Advanced MelanomaPhase 2NCT04493203
Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma
A Phase 2 study testing Nivolumab and Axitinib in people with Advanced Melanoma and Unresectable Melanoma, run by Yana Najjar at 1 site in United States.
Trial summary
This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma, Unresectable Melanoma
- What is being tested?
- Nivolumab and Axitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 12 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have unresectable (stage III) or advanced (stage IV) cutaneous or mucosal melanoma. Patients with uveal melanoma are not eligible.
- Progressed on prior anti-PD1 therapy with or without anti-CTLA4 therapy. Patients may have progressed in the adjuvant setting if treated within the last 6 months. Prior treatment with BRAF/MEK inhibitors permitted, however, not required. Progression must be radiographic, and progression of disease will be confirmed by a radiologist. Patients must have progressed during anti-PD-1 therapy, defined as unequivocal progression on or within 3 months of the last dose of anti-PD-1 therapy if treated in the metastatic setting, or within 6 months if treated in the adjuvant setting.
- Have measurable disease based on RECIST 1.1.
- Patients do not have to have biopsiable disease to be eligible. However, patients with biopsiable disease must undergo biopsy at study entry and at week 12.
- Have a performance status of 0 or 1 on the ECOG Performance Scale.
- Demonstrate adequate organ function, per protocol
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- Patients with brain metastases are permitted if they are asymptomatic or previously treated with CNS directed therapy with stable CNS disease for at least 2 weeks. Stable is defined as asymptomatic or not progressing on imaging.
- Female patients of childbearing potential - negative pregnancy testing; use of birth control, surgically sterile or abstain from heterosexual activity during study and for 5 months after the last dose of study medication.
- Male subjects - agree to use an adequate contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy; abstinence acceptable
Who cannot join
- Prior history of Grade 3 or 4 immune-related adverse events or immune-related adverse events requiring discontinuation of prior therapies.
- History of hypertensive crisis or hypertensive encephalopathy.
- Significant thrombotic (e.g. deep vein thrombosis or pulmonary embolism) or hemorrhagic event within 6 months prior to enrollment.
- History of prior immune-related adverse event due to an anti-PD1 or anti-CTLA4 that has not resolved to grade 1 on a steroid dose of prednisone 10 mg or less at the time of study entry (excluding vitiligo and endocrine toxicity).
- Patients with prior myocarditis or other immune-mediated cardiac adverse events, prior Guillain-Barre syndrome, encephalitis, meningitis, or transverse myelitis, prior Stevens-Johnson syndrome or toxic epidermal necrolysis are excluded regardless of grade.
- Poorly controlled hypertension defined as systolic blood pressure (SBP) > 160 and/or diastolic blood pressure (DBP) > 100 despite antihypertensives. If subject is above this goal, treatment with anti-hypertensives to achieve better blood pressure control is permitted. Ambulatory blood pressure assessment is permitted if there is concern for discrepant blood pressure readings while patients are in clinic.
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- Has Class III or IV heart failure based on the New York Heart Association.
- Has had major surgery within 4 weeks of randomization. This does not include outpatient surgeries that do not require post-operative admission.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than the equivalent of prednisone 10 mg daily, unless for prior endocrine toxicity) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (premedication with steroids for contrast imaging studies is permitted).
- Has a known history of active TB (Bacillus Tuberculosis).
- Hypersensitivity to nivolumab or axitinib, or any of their excipients.
- Has had prior chemotherapy or targeted small molecule therapy within 1 week prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Has had radiation within 2 weeks of randomization.
- Has current use or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP34A4/5) inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice. NOTE: The topical use of these medications, such as 2% ketoconazole cream is allowed.
- Has current use or anticipated need for treatment with drugs known to be strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, in situ colon cancer, or nonmetastatic prostate cancer not on systemic therapy.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 2 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic IV antibiotic therapy.
- Has had any of the following within the past 6 months
- Myocardial infarction or unstable angina
- Ventricular arrythmia
- Acute decompensated heart failure
- Cerebrovascular accident
- Hypertensive emergency requiring ICU admission
- Presence of a disorder that may impact absorption of axitinib, such as inability to take oral medication, requirement for IV alimentation, prior gastric resection, treatment for active peptic ulcer confirmed by endoscopy within the past 3 months, active GI bleed, malabsorption syndrome.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment for females and 7 months after the last dose of trial treatment for males.
- Has a known history of HIV (HIV 1/2 antibodies) if the CD4 count is less than 350 mm3 or serum HIV viral load is < 25,000 IU/mL.
- Has a known history of or is positive for hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (hepatitis C virus [HCV] RNA [qualitative] is detected). Note: Without known history, testing only needs to be performed if there is clinical suspicion for Hepatitis B or C.
- Is currently incarcerated or otherwise detained.
- Has received a live vaccine within 30 days of planned start of study therapy. (intranasal iNinfluenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed)
- Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase II Trial of Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma
This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.
Read the detailed description
This trial hypothesizes that decreasing hypoxia in the TME will re-sensitize melanoma tumors to anti-PD1 therapy. Axitinib has already been safely combined with anti-PD1 therapy and was overall well-tolerated. With nivolumab plus axitinib taken together, based on previously published work and data from our laboratories, it is hypothesized that axitinib can metabolically remodel the TME to render it more sensitive to ICB, specifically by reducing intra-tumoral hypoxia, increasing T cell infiltration, and increasing polyfunctional T cells. It will determined if treatment with nivolumab plus axitinib will prolong both progression-free and overall survival.
- Conditions
- Advanced Melanoma, Unresectable Melanoma
- Being tested
- Nivolumab, Axitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo, AG013736
Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
AxitinibDrug
Also called INLYTA
Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours)
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab plus Axitinib | Experimental | Nivolumab 480mg, IV, every 4 weeks, for up to two years.
Axitinib 5mg, PO, BID, for up to two years. Receives: Drug: Nivolumab; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients (prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab
Percentage of patients (no prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Prior Lines of Therapy <=3
Percentage of patients (<=3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Prior Lines of Therapy >3
Percentage of patients (>3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) by iRECIST
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Primary IO Resistance
Percentage of patients (with primary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Secondary IO Resistance
Percentage of patients (with secondary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Acral Histology
Percentage of patients (acral histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Cutaneous Histology
Percentage of patients (with cutaneous histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Overall Response Rate (ORR) - Mucosal Histology
Percentage of patients (with mucosal histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Prior Lines of Therapy <=3
Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Prior Lines of Therapy >3
Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) by iRECIST
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference the smallest sum diameters while on study. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Secondary IO Resistance
Percentage of patients (with secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Primary IO Resistance
Percentage of patients (with primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Acral Histology
Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Cutaneous Histology
Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Disease Control Rate (DCR) - Mucosal Histology
Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 12 weeks from baseline (after treatment)
Best Response
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - no Prior Ipilimumab / Nivolumab
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Acral Histology
Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Cutaneous Histology
Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Mucosal Histology
Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Prior Lines of Therapy <=3
Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Prior Lines of Therapy >3
Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Measured: Up to 12 weeks from baseline (after treatment)
Best Response by iRECIST
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per iRECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Primary IO Resistance
Percentage of patients (w/ primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres
Measured: Up to 12 weeks from baseline (after treatment)
Best Response - Secondary IO Resistance
Percentage of patients (w/ secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres
Measured: Up to 12 weeks from baseline (after treatment)
Secondary outcomes (137)
Overall Survival (OS) - Overall Cohort
The median number of months from the start of treatment that patients remain alive, until death from any cause.
Measured: Up to 45 months
6-month Overall Survival (OS)
Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Measured: Up to12 months
12-month Overall Survival (OS)
Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Measured: Up to 12 months
24-month Overall Survival (OS)
Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Measured: Up to 24 months
Overall Survival (OS) - Prior Ipilimumab/Nivolumab Treatment
The median number of months from the start of treatment that patients (who received prior Ipilimumab/Nivolumab treatment) remained alive, until death from any cause.
Measured: Up to 45 months
6-month Overall Survival (OS) - Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Measured: Up to 6 months
12-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Measured: Up to 12 months
24-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Measured: Up to 24 months
Overall Survival (OS) - no Prior Ipilimumab / Nivolumab Treatment
The median number of months from the start of treatment that patients (who did not receive prior Ipilimumab /Nivolumab treatment) remained alive, until death from any cause.
Measured: Up to 45 months
6-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Measured: Up to 6 months
12-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Measured: Up to 12 months
24-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Percentage of patients (not previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Measured: Up to 24 months
Overall Survival (OS) - Acral Histology
The median number of months from the start of treatment that patients (with acral histology) remain alive, until death from any cause in patients with acral melanoma histology.
Measured: Up to 45 months
6-month Overall Survival (OS) - Acral Histology
Percentage of patients with acral melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.
Measured: Up to 6 months
12-month Overall Survival (OS) - Acral Histology
Percentage of patients with acral melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.
Measured: Up to 12 months
24-month Overall Survival (OS) - Acral Histology
Percentage of patients with acral melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.
Measured: Up to 24 months
Overall Survival (OS) - Mucosal Histology
The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with mucosal histology.
Measured: Up to 45 months
6-month Overall Survival (OS) - Mucosal Histology
Percentage of patients with mucosal melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.
Measured: Up to 6 months
12-month Overall Survival (OS) - Mucosal Histology
Percentage of patients with mucosal melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.
Measured: Up to 12 months
24-month Overall Survival (OS) - Mucosal Histology
Percentage of patients with mucosal melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.
Measured: Up to 24 months
Overall Survival (OS) - Cutaneous Histology
The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with cutaneous melanoma histology.
Measured: Up to 45 months
6-month Overall Survival (OS) - Cutaneous Histology
Percentage of patients with cutaneous melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.
Measured: Up to 6 months
12-month Overall Survival (OS) - Cutaneous Histology
Percentage of patients with cutaneous melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.
Measured: Up to 12 months
24-month Overall Survival (OS) - Cutaneous Histology
Percentage of patients with cutaneous melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.
Measured: Up to 24 months
Overall Survival (OS) - Prior Lines of Therapy >3
The median number of months from the start of treatment that patients with greater than 3 prior lines of treatment remain alive, until death from any cause.
Measured: Up to 45 months
6-month Overall Survival (OS) - Prior Lines of Therapy >3
Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Measured: Up to 6 months
12-month Overall Survival (OS) - Prior Lines of Therapy >3
Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Measured: Up to 12 months
24-month Overall Survival (OS) - Prior Lines of Therapy >3
Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Measured: Up to 24 months
Overall Survival (OS) - Prior Lines of Therapy <=3
The median number of months from the start of treatment that patients who received 3 or less prior lines of treatment remain alive, until death from any cause.
Measured: Up to 45 months
6-month Overall Survival (OS) - Prior Lines of Therapy <=3
Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Measured: Up to 6 months
12-month Overall Survival (OS) - Prior Lines of Therapy <=3
Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Measured: Up to 12 months
24-month Overall Survival (OS) - Prior Lines of Therapy <=3
Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Measured: Up to 24 months
Overall Survival (OS) - Overall Cohort - Primary IO Resistance
The median number of months from the start of treatment that patients with Primary IO resistance remain alive, until death from any cause.
Measured: Up to 45 months
6-month Overall Survival (OS) - Primary IO Resistance
Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Measured: Up to 6 months
12-month Overall Survival (OS) - Primary IO Resistance
Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Measured: Up to 12 months
24-month Overall Survival (OS) - Primary IO Resistance
Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Measured: Up to 24 months
Overall Survival (OS) - Overall Cohort - Secondary IO Resistance
The median number of months from the start of treatment that patients with Secondary IO resistance remain alive, until death from any cause.
Measured: Up to 45 months
6-month Overall Survival (OS) - Secondary IO Resistance
Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.
Measured: Up to 6 months
12-month Overall Survival (OS) - Secondary IO Resistance
Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.
Measured: Up to 12 months
24-month Overall Survival (OS) - Secondary IO Resistance
Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.
Measured: Up to 24 months
Progression-free Survival (PFS) - Overall Cohort
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS)
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS)
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS)
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (previously treated with Ipilimumab / Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS) - no Prior Ipilimumab/Nivolumab Treatment
The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS) - no Prior Ipilimumab / Nivolumab Treatment
The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment
The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Progression-free Survival (PFS) - Overall Cohort - Mucosal Histology
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS) - Mucosal Histology
The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS) - Mucosal Histology
The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS) - Mucosal Histology
The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Progression-free Survival (PFS) - Overall Cohort - Cutaneous Histology
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS) - Cutaneous Histology
The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS) - Cutaneous Histology
The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS) - Cutaneous Histology
The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Progression-free Survival (PFS) - Overall Cohort - Acral Histology
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS) - Acral Histology
The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS) - Acral Histology
The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS) - Acral Histology
The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Progression-free Survival (PFS) - Overall Cohort - Prior Lines <= 3
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS) - Prior Lines <= 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS) - Prior Lines <= 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS) - Prior Lines <= 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Progression-free Survival (PFS) - Overall Cohort - Prior Lines >3
The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Progression-free Survival (PFS) - Prior Lines > 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Progression-free Survival (PFS) - Prior Lines > 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Progression-free Survival (PFS) - Prior Lines > 3
The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Response (DoR) - Overall Cohort
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 4 years and 3 months
6-month Duration of Response (DoR) - Overall Cohort
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 6 months
12-month Duration of Response (DoR) - Overall Cohort
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 months
24-month Duration of Response (DoR) - Overall Cohort
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 24 months
Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 4 years and 3 months
6-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 6 months
12-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 months
24-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 24 months
Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 4 years and 3 months
6-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 6 months
12-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 months
24-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 24 months
Duration of Response (DoR) - Acral Histology
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 4 years and 3 months
6-month Duration of Response (DoR) - Acral Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 6 months
12-month Duration of Response (DoR) - Acral Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 months
24-month Duration of Response (DoR) - Acral Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 24 months
Duration of Response (DoR) - Mucosal Histology
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 4 years and 3 months
6-month Duration of Response (DoR) - Mucosal Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 6 months
12-month Duration of Response (DoR) - Mucosal Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 months
24-month Duration of Response (DoR) - Mucosal Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 24 months
Duration of Response (DoR) - Cutaneous Histology
Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 4 years and 3 months
6-month Duration of Response (DoR) - Cutaneous Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 6 months
12-month Duration of Response (DoR) - Cutaneous Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 12 months
24-month Duration of Response (DoR) - Cutaneous Histology
Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Overall Cohort
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Overall Cohort
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Overall Cohort
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Overall Cohort
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Acral Histology
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Acral Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Acral Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Acral Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Mucosal Histology
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Mucosal Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Mucosal Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Mucosal Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Cutaneous Histology
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Cutaneous Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Cutaneous Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Cutaneous Histology
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Prior Lines > 3
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Prior Lines > 3
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Prior Lines > 3
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Prior Lines > 3
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Prior Lines <= 3
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Prior Lines <= 3
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Prior Lines <= 3
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Prior Lines <= 3
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Overall Cohort - Primary IO Resistance
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Primary IO Resistance
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Primary IO Resistance
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Primary IO Resistance
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Duration of Disease Control (DoDC) - Overall Cohort - Secondary IO Resistance
Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 4 years and 3 months
6-month Duration of Disease Control (DoDC) - Secondary IO Resistance
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 6 months
12-month Duration of Disease Control (DoDC) - Secondary IO Resistance
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 12 months
24-month Duration of Disease Control (DoDC) - Secondary IO Resistance
Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: Up to 24 months
Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Adverse Events determined to be possibly, probably or definitely related to study treatment SAEs are defined as grade 3 and higher toxicity events that are attributable to the study combination therapy. Evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0).
Measured: Up to 28 days after discontinuation of study treatment (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start18 Dec 2020
- Primary completion15 Apr 2024
- Study completion12 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yana Najjar
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Yana Najjar, University of Pittsburgh
- Investigators
- Yana Najjar, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493203
- Sponsor's protocol ID
- HCC 20-101
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2020
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma
- ClinicalTrials.gov ID
- NCT04493203
- Acronym / sponsor ID
- HCC 20-101
- Conditions
- Advanced Melanoma, Unresectable Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yana NajjarUniversity, hospital or other
- Collaborators
- Pfizer, Bristol-Myers Squibb
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 12 Apr 2025 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.
Detailed description
This trial hypothesizes that decreasing hypoxia in the TME will re-sensitize melanoma tumors to anti-PD1 therapy. Axitinib has already been safely combined with anti-PD1 therapy and was overall well-tolerated. With nivolumab plus axitinib taken together, based on previously published work and data from our laboratories, it is hypothesized that axitinib can metabolically remodel the TME to render it more sensitive to ICB, specifically by reducing intra-tumoral hypoxia, increasing T cell infiltration, and increasing polyfunctional T cells. It will determined if treatment with nivolumab plus axitinib will prolong both progression-free and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab plus Axitinib | Experimental | Drug: Nivolumab, Drug: AxitinibNivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have unresectable (stage III) or advanced (stage IV) cutaneous or mucosal melanoma. Patients with uveal melanoma are not eligible.
- Progressed on prior anti-PD1 therapy with or without anti-CTLA4 therapy. Patients may have progressed in the adjuvant setting if treated within the last 6 months. Prior treatment with BRAF/MEK inhibitors permitted, however, not required. Progression must be radiographic, and progression of disease will be confirmed by a radiologist. Patients must have progressed during anti-PD-1 therapy, defined as unequivocal progression on or within 3 months of the last dose of anti-PD-1 therapy if treated in the metastatic setting, or within 6 months if treated in the adjuvant setting.
- Have measurable disease based on RECIST 1.1.
- Patients do not have to have biopsiable disease to be eligible. However, patients with biopsiable disease must undergo biopsy at study entry and at week 12.
- Have a performance status of 0 or 1 on the ECOG Performance Scale.
Key exclusion criteria (36 listed)
- Prior history of Grade 3 or 4 immune-related adverse events or immune-related adverse events requiring discontinuation of prior therapies.
- History of hypertensive crisis or hypertensive encephalopathy.
- Significant thrombotic (e.g. deep vein thrombosis or pulmonary embolism) or hemorrhagic event within 6 months prior to enrollment.
- History of prior immune-related adverse event due to an anti-PD1 or anti-CTLA4 that has not resolved to grade 1 on a steroid dose of prednisone 10 mg or less at the time of study entry (excluding vitiligo and endocrine toxicity).
- Patients with prior myocarditis or other immune-mediated cardiac adverse events, prior Guillain-Barre syndrome, encephalitis, meningitis, or transverse myelitis, prior Stevens-Johnson syndrome or toxic epidermal necrolysis are excluded regardless of grade.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo, AG013736Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. | Drug | Nivolumab plus Axitinib |
| AxitinibAlso: INLYTAAxitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours) | Drug | Nivolumab plus Axitinib |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (no prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - Prior Lines of Therapy <=3
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (<=3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - Prior Lines of Therapy >3
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (>3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) by iRECIST
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Overall Response Rate (ORR) - Primary IO Resistance
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with primary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - Secondary IO Resistance
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with secondary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - Acral Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (acral histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - Cutaneous Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with cutaneous histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Overall Response Rate (ORR) - Mucosal Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with mucosal histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Disease Control Rate (DCR)
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - Prior Lines of Therapy <=3
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - Prior Lines of Therapy >3
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) by iRECIST
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference the smallest sum diameters while on study. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Disease Control Rate (DCR) - Secondary IO Resistance
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - Primary IO Resistance
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - Acral Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - Cutaneous Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Disease Control Rate (DCR) - Mucosal Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Best Response
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Best Response - no Prior Ipilimumab / Nivolumab
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Best Response - Prior Ipilimumab / Nivolumab Treatment
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Best Response - Acral Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Best Response - Cutaneous Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression
Best Response - Mucosal Histology
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression
Best Response - Prior Lines of Therapy <=3
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Best Response - Prior Lines of Therapy >3
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Best Response by iRECIST
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per iRECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD
Best Response - Primary IO Resistance
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (w/ primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres
Best Response - Secondary IO Resistance
Time frame: Up to 12 weeks from baseline (after treatment)
Percentage of patients (w/ secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres
137 secondary outcomes
Overall Survival (OS) - Overall Cohort
Time frame: Up to 45 months
6-month Overall Survival (OS)
Time frame: Up to12 months
12-month Overall Survival (OS)
Time frame: Up to 12 months
24-month Overall Survival (OS)
Time frame: Up to 24 months
Overall Survival (OS) - Prior Ipilimumab/Nivolumab Treatment
Time frame: Up to 45 months
6-month Overall Survival (OS) - Prior Ipilimumab /Nivolumab Treatment
Time frame: Up to 6 months
12-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment
Time frame: Up to 12 months
24-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment
Time frame: Up to 24 months
Overall Survival (OS) - no Prior Ipilimumab / Nivolumab Treatment
Time frame: Up to 45 months
6-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Time frame: Up to 6 months
12-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Time frame: Up to 12 months
24-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment
Time frame: Up to 24 months
Overall Survival (OS) - Acral Histology
Time frame: Up to 45 months
6-month Overall Survival (OS) - Acral Histology
Time frame: Up to 6 months
12-month Overall Survival (OS) - Acral Histology
Time frame: Up to 12 months
24-month Overall Survival (OS) - Acral Histology
Time frame: Up to 24 months
Overall Survival (OS) - Mucosal Histology
Time frame: Up to 45 months
6-month Overall Survival (OS) - Mucosal Histology
Time frame: Up to 6 months
12-month Overall Survival (OS) - Mucosal Histology
Time frame: Up to 12 months
24-month Overall Survival (OS) - Mucosal Histology
Time frame: Up to 24 months
Overall Survival (OS) - Cutaneous Histology
Time frame: Up to 45 months
6-month Overall Survival (OS) - Cutaneous Histology
Time frame: Up to 6 months
12-month Overall Survival (OS) - Cutaneous Histology
Time frame: Up to 12 months
24-month Overall Survival (OS) - Cutaneous Histology
Time frame: Up to 24 months
Overall Survival (OS) - Prior Lines of Therapy >3
Time frame: Up to 45 months
6-month Overall Survival (OS) - Prior Lines of Therapy >3
Time frame: Up to 6 months
12-month Overall Survival (OS) - Prior Lines of Therapy >3
Time frame: Up to 12 months
24-month Overall Survival (OS) - Prior Lines of Therapy >3
Time frame: Up to 24 months
Overall Survival (OS) - Prior Lines of Therapy <=3
Time frame: Up to 45 months
6-month Overall Survival (OS) - Prior Lines of Therapy <=3
Time frame: Up to 6 months
12-month Overall Survival (OS) - Prior Lines of Therapy <=3
Time frame: Up to 12 months
24-month Overall Survival (OS) - Prior Lines of Therapy <=3
Time frame: Up to 24 months
Overall Survival (OS) - Overall Cohort - Primary IO Resistance
Time frame: Up to 45 months
6-month Overall Survival (OS) - Primary IO Resistance
Time frame: Up to 6 months
12-month Overall Survival (OS) - Primary IO Resistance
Time frame: Up to 12 months
24-month Overall Survival (OS) - Primary IO Resistance
Time frame: Up to 24 months
Overall Survival (OS) - Overall Cohort - Secondary IO Resistance
Time frame: Up to 45 months
6-month Overall Survival (OS) - Secondary IO Resistance
Time frame: Up to 6 months
12-month Overall Survival (OS) - Secondary IO Resistance
Time frame: Up to 12 months
24-month Overall Survival (OS) - Secondary IO Resistance
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yana Najjar, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Axitinib in people with Advanced Melanoma and Unresectable Melanoma, run by Yana Najjar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to 12 weeks from baseline (after treatment)). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.