Metastatic MelanomaPhase 2NCT07504796
ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
A Phase 2 study testing Nivolumab, Relatlimab and Ipilimumab in people with Metastatic Melanoma and Advanced Melanoma, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of ctDNA measurements to guide first-lien therapy choice for patients with advanced or metastatic melanoma. Primary endpoints include progression-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma, Advanced Melanoma
- What is being tested?
- Nivolumab, Relatlimab and Ipilimumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to May 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patient must be ≥ 18 years old.
- Patients must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent from (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care.
- Patients must be willing and able to comply with scheduled visits, laboratory tests, and other requirements of the study.
- Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. Patients with mucosal melanoma defined as unresectable stage III or regional/distant metastatic disease are eligible.
- Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible.
- Patient must have at least one lesion for measurable disease per RECIST 1.1 guidelines (refer to section 8.1 for more information).
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- Patients must have specimen required for study procedures, including either archived tumor tissue or fresh tissue and whole blood available, at baseline to send to Natera as part of screening for Signatera testing to be completed. (refer to section 8.2 for more information)
- Patient must be planned to initiate standard of care first-line therapy for metastatic disease
- Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical). Exceptions: Surgery for melanoma and/or post-resection brain radiotherapy (RT) if central nervous system (CNS) metastases and adjuvant RT for locoregional disease after resection. Prior treatment with the following therapies in the adjuvant setting: interferon (IFN)-alpha therapy, BRAF/MEK therapy (e.g. dabrafenib and trametinib), anti-PD-1 therapy (e.g. pembrolizumab or nivolumab), or anti-CTLA-4 therapy (e.g. ipilimumab) is allowed if therapy has been completed for 6 months (see criterion 10).
- All patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug. Imaging studies must include computerized tomography (CT) scan of chest, abdomen, pelvis, and all known sites of resected disease in the setting of Stage IIIB/C/D or Stage IV disease, and brain magnetic resonance imaging ([MRI]; brain CT is allowable if MRI is contraindicated).
- The complete set of baseline radiographic images must be available before treatment initiation. Prior treatment with adjuvant IFN-alpha, adjuvant ipilimumab and/or nivolumab or pembrolizumab or BRAF/MEK therapy (e.g. dabrafenib and trametinib) are allowed if recurrence of disease occurred more than 6 months from the last dose of adjuvant therapy; that is, a patient must have recurred with unresectable disease at least 6 months or more after finishing adjuvant therapy; combination adjuvant therapies with nivolumab or pembrolizumab are also allowed (vaccines, bempegaldesleukin, relatlimab, etc.).
- Patients must have detectable ctDNA at baseline. A blood sample will be collected during the screening phase in order to determine if patients are eligible based on presence of ctDNA. Patients are permitted to start treatment with nivolumab/relatlimab cycle 1 while awaiting results.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Patients with prior or concurrent nonmelanoma malignancies whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this study.
- Asymptomatic brain metastases are permitted. Patients who have received/will receive gamma knife radiotherapy or stereotactic body radiation therapy (SBRT) treated lesions are also eligible. Patients must be on < 10 mg of prednisone or equivalent at the time of treatment.
- All baseline laboratory requirements will be assessed and should be obtained within 14 days of C1D1. Screening laboratory values must meet the following criteria:
- white blood cells (WBCs) ≥ 2000/μL
- Neutrophils ≥ 1500/μL
- Platelets ≥ 100 × 10³/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)
- Aspartate Aminotransferase (AST) ≤ 1.5 × ULN
- Alanine Aminotransferase (ALT) ≤ 1.5 × ULN
- Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)
- Coagulation : Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR)
Who cannot join
- Patients with carcinomatosis meningitis or a history of current ocular/uveal melanoma are excluded.
- Patients with a history of myocarditis.
- Patients with active, known, or suspected autoimmune disease requiring immunosuppression beyond 10 mg daily of prednisone. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent.
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of C1D1. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
- Patients must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible.
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with or would otherwise affect study participation.
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- Known hypersensitivity to monoclonal antibodies
- Pregnancy
- Prior therapy for melanoma with the following exceptions which are allowed: 1) surgery for the melanoma lesion(s), 2) adjuvant RT after neurosurgical resection for CNS lesions or for resected locoregional disease, and 3) prior adjuvant therapy as long as concluded 6 months prior.
- Any of the following laboratory abnormalities:
- Absolute Neutrophil Count (ANC) < 1,500/μL or WBC < 2,000 μL
- Platelet count < 100,000/μL
- Hematologic growth factors are not allowed at screening or during the first cycle of treatment
- Hemoglobin < 9 g/dL (< 5.5 mmol/L; previous red blood cell (RBC) transfusion is permitted)
- Creatinine > 1.5 × ULN
- AST or ALT > 1.5 × ULN. For patients with liver metastasis AST or ALT > 3 × ULN
- Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Trials Office contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced Melanoma
The purpose of this study is to investigate the use of ctDNA measurements to guide first-lien therapy choice for patients with advanced or metastatic melanoma. Primary endpoints include progression-free survival. Secondary study endpoints include objective response rate and incidence and severity of immune-related adverse events.
Read the detailed description
This study's approach seeks to rationally, rather than empirically, choose one treatment approach over another, as well as to develop methods to predict disease recurrence at earlier time points. The combination of ipilimumab and nivolumab is the standard of care for first-line treatment of advanced melanoma. This study instead seeks to pioneer treatment choice based on evidence of molecular relapse, and to determine whether this results in superior outcomes compared with the current standard of care to treat until evidence of radiologic progression. Patients with sustained "zeroconversion" may not require an immediate switch, while patients whose ctDNA levels are detectable and/or rising may benefit from an earlier therapeutic switch. The overall goal is to improve patient selection for therapy, thus sparing the therapeutic and financial toxicities from therapies that have stopped working (i.e. patients with rising ctDNA levels) or are perhaps not necessary (patients who have sustained zeroconversion).
- Conditions
- Metastatic Melanoma, Advanced Melanoma
- Being tested
- Nivolumab, Relatlimab, Ipilimumab, Signatera genome MRD assay
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
480 mg Nivolumab every 4 weeks
RelatlimabDrug
160 mg Relatlimab every 4 weeks
IpilimumabDrug
50 mg (1 mg/kg) intravenously every 8 weeks
Signatera genome MRD assayDevice
SignateraTM is a personalized, tumor-informed circulating tumor DNA (ctDNA)-based test of molecular residual disease (MRD). The Signatera Designed on Genome test is a qualitative and quantitative test that reports the presence or absence of ctDNA as "ctDNA Positive" or "ctDNA Not Detected".
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Undetectable ctDNA | Experimental | Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients with undetectable ctDNA ("zeroconversion") will continue on this regimen until radiologic progression or death for up to 2 years, per standard of care. Receives: Drug: Nivolumab; Drug: Relatlimab; Device: Signatera genome MRD assay |
| Cohort B: Positive ctDNA without early progresson (continue treatment) | Active comparator | Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients who exhibit positive ctDNA at week 6, who do not exhibit "zeroconverson" at week 6 will be randomized to one of two treatment arms in Cohort B. In this arm patients continue treatment with 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4 week intervals. Receives: Drug: Nivolumab; Drug: Relatlimab; Device: Signatera genome MRD assay |
| Cohort B: Positive ctDNA without early progression (switch treatment) | Experimental | Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients who exhibit positive ctDNA at week 6, who do not exhibit "zeroconverson" at week 6 will be randomized to one of two treatment arms in Cohort B. In this arm patients receive 1 dose of ipilimumab at 1 mg/kg in 8 week intervals in addition to 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4 week intervals. Receives: Drug: Nivolumab; Drug: Relatlimab; Drug: Ipilimumab; Device: Signatera genome MRD assay |
| Cohort C: Positive ctDNA with early progression | Experimental | Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients with positive ctDNA and progressive disease (early progression) on scans at week 6 will switch to ipilimumab at 1 mg/kg in 8-week intervals in addition to 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4-week intervals. Cohort C patients will continue on this regimen until radiologic progression or death for up to 2 years, per standard of care. Receives: Drug: Nivolumab; Drug: Relatlimab; Drug: Ipilimumab; Device: Signatera genome MRD assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival rate in patients randomized in Cohort B
Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 (with irRECIST used as a supportive criterion) or death from any cause, whichever occurs earlier.
Measured: Month 6
Secondary outcomes (5)
Objective response rate (CR+PR)
Objective response rate (ORR) (CR+PR) by RECIST 1.1, with irRECIST supportive, reported as the percentage of patients achieving response in all cohorts. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (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; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. The ORR is the response recorded from the start of the treatment until month 6
Measured: Month 6
Incidence of immune-related adverse events (irAEs) with ipilimumab, relatlimab, and nivolumab triplet therapy administered after prior nivolumab plus relatlimab doublet therapy.
From the first treatment administration until final on-treatment visit.
Measured: Up to 2 years
Progression-free survival in Cohorts A and C
Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 (with irRECIST used as a supportive criterion) or death from any cause, whichever occurs earlier.
Measured: Month 6
Progression-free survival
Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 (with irRECIST used as a supportive criterion) or death from any cause, whichever occurs earlier.
Measured: Month 12
Progression-free survival
Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 (with irRECIST used as a supportive criterion) or death from any cause, whichever occurs earlier.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start13 Apr 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice M. Mehnert, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504796
- Sponsor's protocol ID
- 25-00592
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone s Data Sharing Strategy Board (DSSB). Requests should be directed to: cancertrials@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced Melanoma
- ClinicalTrials.gov ID
- NCT07504796
- Acronym / sponsor ID
- 25-00592
- Conditions
- Metastatic Melanoma, Advanced Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the use of ctDNA measurements to guide first-lien therapy choice for patients with advanced or metastatic melanoma. Primary endpoints include progression-free survival. Secondary study endpoints include objective response rate and incidence and severity of immune-related adverse events.
Detailed description
This study's approach seeks to rationally, rather than empirically, choose one treatment approach over another, as well as to develop methods to predict disease recurrence at earlier time points. The combination of ipilimumab and nivolumab is the standard of care for first-line treatment of advanced melanoma. This study instead seeks to pioneer treatment choice based on evidence of molecular relapse, and to determine whether this results in superior outcomes compared with the current standard of care to treat until evidence of radiologic progression. Patients with sustained "zeroconversion" may not require an immediate switch, while patients whose ctDNA levels are detectable and/or rising may benefit from an earlier therapeutic switch. The overall goal is to improve patient selection for therapy, thus sparing the therapeutic and financial toxicities from therapies that have stopped working (i.e. patients with rising ctDNA levels) or are perhaps not necessary (patients who have sustained zeroconversion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Undetectable ctDNA | Experimental | Drug: Nivolumab, Drug: Relatlimab, Device: Signatera genome MRD assayPatients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients with undetectable ctDNA ("zeroconversion") will continue on this regimen until radiologic progression or death for up to 2 years, per standard of care. |
| Cohort B: Positive ctDNA without early progresson (continue treatment) | Active comparator | Drug: Nivolumab, Drug: Relatlimab, Device: Signatera genome MRD assayPatients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients who exhibit positive ctDNA at week 6, who do not exhibit "zeroconverson" at week 6 will be randomized to one of two treatment arms in Cohort B. In this arm patients continue treatment with 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4 week intervals. |
| Cohort B: Positive ctDNA without early progression (switch treatment) | Experimental | Drug: Nivolumab, Drug: Relatlimab, Drug: Ipilimumab, Device: Signatera genome MRD assayPatients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients who exhibit positive ctDNA at week 6, who do not exhibit "zeroconverson" at week 6 will be randomized to one of two treatment arms in Cohort B. In this arm patients receive 1 dose of ipilimumab at 1 mg/kg in 8 week intervals in addition to 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4 week intervals. |
| Cohort C: Positive ctDNA with early progression | Experimental | Drug: Nivolumab, Drug: Relatlimab, Drug: Ipilimumab, Device: Signatera genome MRD assayPatients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients with positive ctDNA and progressive disease (early progression) on scans at week 6 will switch to ipilimumab at 1 mg/kg in 8-week intervals in addition to 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4-week intervals. Cohort C patients will continue on this regimen until radiologic progression or death for up to 2 years, per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patient must be ≥ 18 years old.
- Patients must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent from (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care.
- Patients must be willing and able to comply with scheduled visits, laboratory tests, and other requirements of the study.
- Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. Patients with mucosal melanoma defined as unresectable stage III or regional/distant metastatic disease are eligible.
- Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible.
Key exclusion criteria (17 listed)
- Patients with carcinomatosis meningitis or a history of current ocular/uveal melanoma are excluded.
- Patients with a history of myocarditis.
- Patients with active, known, or suspected autoimmune disease requiring immunosuppression beyond 10 mg daily of prednisone. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent.
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of C1D1. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
- Patients must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible.
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 |
|---|---|---|
| Nivolumab480 mg Nivolumab every 4 weeks | Drug | Cohort A: Undetectable ctDNA, Cohort B: Positive ctDNA without early progression (switch treatment), Cohort B: Positive ctDNA without early progresson (continue treatment), Cohort C: Positive ctDNA with early progression |
| Relatlimab160 mg Relatlimab every 4 weeks | Drug | Cohort A: Undetectable ctDNA, Cohort B: Positive ctDNA without early progression (switch treatment), Cohort B: Positive ctDNA without early progresson (continue treatment), Cohort C: Positive ctDNA with early progression |
| Ipilimumab50 mg (1 mg/kg) intravenously every 8 weeks | Drug | Cohort B: Positive ctDNA without early progression (switch treatment), Cohort C: Positive ctDNA with early progression |
| Signatera genome MRD assaySignateraTM is a personalized, tumor-informed circulating tumor DNA (ctDNA)-based test of molecular residual disease (MRD). The Signatera Designed on Genome test is a qualitative and quantitative test that reports the presence or absence of ctDNA as "ctDNA Positive" or "ctDNA Not Detected". | Device | Cohort A: Undetectable ctDNA, Cohort B: Positive ctDNA without early progression (switch treatment), Cohort B: Positive ctDNA without early progresson (continue treatment), Cohort C: Positive ctDNA with early progression |
Primary outcome
Progression Free Survival rate in patients randomized in Cohort B
Time frame: Month 6
Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 (with irRECIST used as a supportive criterion) or death from any cause, whichever occurs earlier.
5 secondary outcomes
Objective response rate (CR+PR)
Time frame: Month 6
Incidence of immune-related adverse events (irAEs) with ipilimumab, relatlimab, and nivolumab triplet therapy administered after prior nivolumab plus relatlimab doublet therapy.
Time frame: Up to 2 years
Progression-free survival in Cohorts A and C
Time frame: Month 6
Progression-free survival
Time frame: Month 12
Progression-free survival
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone s Data Sharing Strategy Board (DSSB). Requests should be directed to: cancertrials@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Cancer Trials Office contact
Janice M. Mehnert, MD principal investigator
NYU Langone Health
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, Relatlimab and Ipilimumab in people with Metastatic Melanoma and Advanced Melanoma, run by NYU Langone Health 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 25 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janice M. Mehnert, MD (212-731-5431, janice.mehnert@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival rate in patients randomized in Cohort B (time frame: Month 6). 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 24 Aug 2026.