MelanomaPhase 2NCT04698187
CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
A Phase 2 study testing CMP-001 and Nivolumab in people with Melanoma and Advanced Melanoma, run by Regeneron Pharmaceuticals at 25 sites in United States.
Trial summary
CMP-001-010 is a Phase 2 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) administered to participants with refractory unresectable or metastatic melanoma. The primary objective of the study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Advanced Melanoma, Metastatic Melanoma
- What is being tested?
- CMP-001 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 25 sitesUnited States
- Study dates
- 11 Mar 2021to 5 Feb 2024
- 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
- Subjects enrolled in the study must meet all of the following inclusion criteria to be eligible.
- Histopathologically-confirmed diagnosis of malignant melanoma that is metastatic or unresectable at Screening.
- Known BRAF mutation status; if BRAF V600 mutation positive, must have had prior treatment with a local Health Authority approved BRAF inhibitor, with or without mitogen-activated protein kinase inhibitor. Patients with BRAF V600 mutations who refuse a BRAF inhibitor will not be eligible.
- Refractory to PD-1 blockade either as monotherapy or in combination with other therapies, as defined by the following criteria:
- Received treatment with a Food and Drug Administration approved PD-1 blocking antibody for 12 weeks or longer.
- Have PD (according to RECIST v1.1) within 12 weeks of the last dose of a PD-1 blocking antibody, either as monotherapy or in combination with other agents.
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- Evidence of confirmed PD must be established by investigator assessment at least 4 weeks after the initial date of PD. The second assessment may serve as the Baseline for this study if completed within 30 days before to the start of study treatment. NOTE: in subjects with histologically confirmed recurrence on or after adjuvant PD-1 blocking antibody, confirmatory imaging is not required.
- Measurable disease, as defined by RECIST v1.1 and all of the following:
- At least 1 accessible lesion amenable to repeated IT injection.
- One or more measurable lesions at least 1 cm in diameter that are not intended for CMP 001 injection and can be followed as target lesions per RECIST v1.1.
- Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion.
- Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A fresh tissue biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable if no intervening therapy was received. Note: For tissue sampling details, please refer to the laboratory manual.
- Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1):
- Bone marrow function:
- neutrophil count ≥ 1500/mm3
- platelet count ≥ 100,000/mm3
- hemoglobin concentration ≥ 9 g/dL
- white blood cells ≥ 2000/mm3
- Liver function:
- total bilirubin ≤ 1.5 times the upper limit of normal (ULN) with the following exception: patients with Gilbert Disease total serum bilirubin ≤ 3 times ULN
- aspartate aminotransferase and alanine aminotransferase ≤ 3 times the ULN
- Lactate dehydrogenase ≤ 2 times the ULN
- Renal function: estimated (Cockcroft-Gault) or measured creatinine clearance ≥ 30 mL/min.
- Coagulation:
- International normalized ratio or prothrombin time (PT) ≤ 1.5 times ULN, unless subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time or PTT ≤ 1.5 times ULN, unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Age ≥ 18 years at time of consent.
- Eastern Cooperative Oncology Group Performance Status of 0 to 1 at Screening.
- Capable of understanding and complying with protocol requirements.
- Women of childbearing potential must have negative serum pregnancy test before dosing at W1D1 and be willing to use an adequate method of contraception from the time of consent until at least 150 days after last dose of study treatment.
- Able and willing to provide written informed consent and to follow study instructions. Subjects unable to provide written informed consent on their own behalf will not be eligible for the study.
Who cannot join
- Subjects presenting with any of the following will not qualify for entry into the study:
- Uveal, acral, or mucosal melanoma.
- Received radiation therapy (or other nonsystemic therapy) within 2 weeks before first dose of study treatment on W1D1. Patients should have recovered (ie, Grade ≤1 or at baseline) from radiation-related toxicities.
- Treatment with complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before start of study treatment. Refer to Section 4.4. for prohibited therapies.
- Received systemic pharmacologic doses of corticosteroids ≥10 mg/day prednisone within 30 days before first dose of study treatment on W1D1.
- Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤ 10 mg/day do not need to discontinue steroids before enrollment.
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- Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
- Stress-dose corticosteroids will be required in subjects with adrenal insufficiency
- History of immune-related AE that required permanent discontinuation of PD-1 blocking antibody.
- Not fully recovered from AEs (to Grade 1 or less [per CTCAE v5.0], with the exception of persistent adverse events or sequelae, eg, vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency) due to prior treatment.
- NOTE: Subjects previously treated with a CTLA-4-blocking antibody, subjects receiving corticosteroids with daily doses > 5 mg and ≤ 10 mg of prednisone equivalent for 2 weeks, and subjects with clinical symptoms and/or laboratory findings suggesting risk for adrenal insufficiency should undergo diagnostic tests for adrenal insufficiency via local laboratory.
- Active pneumonitis or history of noninfectious pneumonitis that required steroids.
- Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator.
- Known history of immunodeficiency.
- Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include cancers that have undergone potentially curative therapy, eg, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer with prostate-specific antigen level below 4.0 ng/mL, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic), in situ breast cancer, and adjuvant hormonal therapy for breast cancer > 3 years from curative-intent surgical resection.
- Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
- Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).
- Prior allogenic tissue/solid organ transplant.
- Active infection requiring systemic therapy.
- Known or suspected active infection with severe acute respiratory syndrome coronavirus 2 virus.
- Known or suspected active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (testing is not required unless suspected).
- Received a live virus/attenuated vaccination within 30 days before first dose of study treatment on W1D1.
- Received blood products (including platelets or red blood cells) or colony stimulating factors (including granulocyte colony stimulating factor, granulocyte/macrophage colony stimulating factor, or recombinant erythropoietin) within 30 days before the start of Screening.
- History of allergy or hypersensitivity to nivolumab and/or any of its excipients.
- Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator would make the subject unable to cooperate or participate in the study.
- Participation in another clinical study of an investigational anticancer therapy or device within 30 days before first dose of study treatment on W1D1. Participation in the follow-up phase (receiving no study treatment) of a prior study is allowed.
- Requires prohibited treatment (ie, non-protocol specified anticancer pharmacotherapy, surgery, or radiotherapy) for treatment of malignant tumor.
- Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator.
- Received previous CMP-001 treatment.
- Pregnant or breastfeeding or expecting to conceive or donate eggs within the projected duration of the study, from the time of consent until at least 150 days after last dose of study treatment for women.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University Cancer & Blood Center
Athens, Georgia, 30607
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
The Ohio State University
Columbus, Ohio, 43220
Sammons Cancer Center
Dallas, Texas, 75246
University of Colorado- Denver
Denver, Colorado, 80204
City of Hope National Medical Center, Robert Kang, MD
Duarte, California, 91010
Duke University Cancer Institute
Durham, North Carolina, 27710
Hartford Healthcare
Hartford, Connecticut, 06106
University of Iowa
Iowa City, Iowa, 52242
GenesisCare USA
Jacksonville, Florida, 32204
UCLA Hematology-Oncology
Los Angeles, California, 90095
University of Louisville Health Care
Louisville, Kentucky, 40202
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Orlando Health
Orlando, Florida, 32806
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
University of Utah- Huntsman Cancer Institute
Salt Lake City, Utah, 84112
California Cancer Associates for Research & Excellence, Inc.
San Marcos, California, 92069
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: A Multicenter, Open-label, Phase 2 Study of Intratumoral CMP-001 in Combination With Intravenous Nivolumab in Subjects With Refractory Unresectable or Metastatic Melanoma
CMP-001-010 is a Phase 2 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) administered to participants with refractory unresectable or metastatic melanoma.
The primary objective of the study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
Read more
The secondary objectives are to:
- To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
- To evaluate the efficacy of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
- To assess the pharmacokinetic (PK) profile of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
- To assess and describe the immunogenicity of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
Read the detailed description
Former Sponsor Checkmate Pharmaceuticals
- Being tested
- CMP-001, Nivolumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMP-001Drug
Also called vidutolimod
Subjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W).
NivolumabDrug
Also called OPDIVO
Nivolumab 360 mg IV is administered Q3W.
| Study group | Role | What they receive |
|---|---|---|
| CMP-001 and Nivolumab | Experimental | All enrolled subjects will receive CMP-001 IT and nivolumab IV according to the treatment schedule until a reason for treatment discontinuation is reached. Receives: Drug: CMP-001; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)
Measured: Up to approximately 24 months (107 weeks)
Secondary outcomes (18)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.
Measured: Up to approximately 24 months (107 weeks)
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported:
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event
Measured: Up to approximately 24 months (107 weeks)
Time to Response (TTR) by BICR
TTR, defined as the time from the first dose date of the study treatment to the first time when criteria are first met for CR or PR, whichever occurred first, per RECIST v1.1 by BICR.
Measured: Up to approximately 28 months (122 weeks)
Time to Response (TTR) by Investigator
TTR, defined as the time from the first dose date of the study treatment to the first time when criteria are first met for CR or PR, whichever occurred first, per RECIST v1.1 by Investigator.
Measured: Up to approximately 28 months (122 weeks)
Duration of Response (DOR) by BICR
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST v1.1 by BICR.
Measured: Up to approximately 28 months (122 weeks)
Duration of Response (DOR) by Investigator
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST v1.1 by Investigator.
Measured: Up to approximately 28 months (122 weeks)
Confirmed ORR in Non-injected Target Lesions by Investigator
Confirmed ORR, defined as the percentage of participants in the analysis set who had confirmed BOR of CR or PR based on RECIST v1.1 as assessed by Investigator.
Measured: Up to approximately 24 months (107 weeks)
Progression-free Survival (PFS) by BICR
PFS, defined as time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 by BICR or death, whichever occurred first.
Measured: Up to approximately 31 months (135 weeks)
Progression-free Survival (PFS) by Investigator
PFS, defined as time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 by Investigator or death, whichever occurred first.
Measured: Up to approximately 31 months (135 weeks)
Overall Survival (OS) by Investigator
OS, defined as the time from the first dose date of the study treatment to the date of death from any cause.
Measured: Up to approximately 32 months (139 weeks)
Immune Objective Response Rate (iORR) by Investigator
iORR, defined as the percentage of participants with an immune best overall response (iBOR) of confirmed immune complete response (iCR) or confirmed immune partial response (iPR) based on immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by Investigator assessment.
Measured: Up to approximately 24 months (107 weeks)
Immune Duration of Response (iDOR) by Investigator
iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by Investigator assessment.
Measured: Up to approximately 28 months (122 weeks)
Immune Progression-free Survival (iPFS) by Investigator
iPFS, defined as the time from the first dose date of the study treatment to date of immune confirmed progressive disease (iCPD) per iRECIST by Investigator assessment or death, whichever occurred first.
Measured: Up to 9 months (approximately 39 weeks)
Maximum Observed Serum Concentration
Assess the pharmacokinetic (PK) profile for maximum observed serum concentration.
Measured: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Area Under the Serum Concentration-Time Curve From Time Zero to the Last Quantifiable Time Point
Assess the PK profile for area under the serum concentration-time curve from time zero to the last quantifiable time point.
Measured: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity
Assess the PK profile for area under the serum concentration-time curve from time zero extrapolated to infinity.
Measured: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Terminal Elimination Half-Life
Assess the PK profile for terminal elimination half-life.
Measured: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Number of Participants With Immunogenicity as Measured by Anti-Qbeta Antibodies (ADA)
Development of anti-Qbeta antibodies in participants with refractory unresectable or metastatic melanoma.
Measured: Up to approximately 24 months (107 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start11 Mar 2021
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Why it stopped: Business Decision
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 MelanomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698187
- Sponsor's protocol ID
- CMP-001-010
- Status last verified
- Jun 2025
- First submitted
- 10 Dec 2020
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 2 Study of Intratumoral CMP-001 in Combination With Intravenous Nivolumab in Subjects With Refractory Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT04698187
- Acronym / sponsor ID
- CMP-001-010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CMP-001-010 is a Phase 2 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) administered to participants with refractory unresectable or metastatic melanoma.
The primary objective of the study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
The secondary objectives are to:
- To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
- To evaluate the efficacy of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
- To assess the pharmacokinetic (PK) profile of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
- To assess and describe the immunogenicity of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
Detailed description
Former Sponsor Checkmate Pharmaceuticals
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMP-001 and Nivolumab | Experimental | Drug: CMP-001, Drug: NivolumabAll enrolled subjects will receive CMP-001 IT and nivolumab IV according to the treatment schedule until a reason for treatment discontinuation is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Subjects enrolled in the study must meet all of the following inclusion criteria to be eligible.
- Histopathologically-confirmed diagnosis of malignant melanoma that is metastatic or unresectable at Screening.
- Known BRAF mutation status; if BRAF V600 mutation positive, must have had prior treatment with a local Health Authority approved BRAF inhibitor, with or without mitogen-activated protein kinase inhibitor. Patients with BRAF V600 mutations who refuse a BRAF inhibitor will not be eligible.
- Refractory to PD-1 blockade either as monotherapy or in combination with other therapies, as defined by the following criteria:
- Evidence of confirmed PD must be established by investigator assessment at least 4 weeks after the initial date of PD. The second assessment may serve as the Baseline for this study if completed within 30 days before to the start of study treatment. NOTE: in subjects with histologically confirmed recurrence on or after adjuvant PD-1 blocking antibody, confirmatory imaging is not required.
Key exclusion criteria (30 listed)
- Uveal, acral, or mucosal melanoma.
- Received radiation therapy (or other nonsystemic therapy) within 2 weeks before first dose of study treatment on W1D1. Patients should have recovered (ie, Grade ≤1 or at baseline) from radiation-related toxicities.
- Treatment with complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before start of study treatment. Refer to Section 4.4. for prohibited therapies.
- Received systemic pharmacologic doses of corticosteroids ≥10 mg/day prednisone within 30 days before first dose of study treatment on W1D1.
- History of immune-related AE that required permanent discontinuation of PD-1 blocking antibody.
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 |
|---|---|---|
| CMP-001Also: vidutolimodSubjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W). | Drug | CMP-001 and Nivolumab |
| NivolumabAlso: OPDIVONivolumab 360 mg IV is administered Q3W. | Drug | CMP-001 and Nivolumab |
Primary outcome
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 24 months (107 weeks)
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)
18 secondary outcomes
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Time frame: Up to approximately 24 months (107 weeks)
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: Up to approximately 24 months (107 weeks)
Time to Response (TTR) by BICR
Time frame: Up to approximately 28 months (122 weeks)
Time to Response (TTR) by Investigator
Time frame: Up to approximately 28 months (122 weeks)
Duration of Response (DOR) by BICR
Time frame: Up to approximately 28 months (122 weeks)
Duration of Response (DOR) by Investigator
Time frame: Up to approximately 28 months (122 weeks)
Confirmed ORR in Non-injected Target Lesions by Investigator
Time frame: Up to approximately 24 months (107 weeks)
Progression-free Survival (PFS) by BICR
Time frame: Up to approximately 31 months (135 weeks)
Progression-free Survival (PFS) by Investigator
Time frame: Up to approximately 31 months (135 weeks)
Overall Survival (OS) by Investigator
Time frame: Up to approximately 32 months (139 weeks)
Immune Objective Response Rate (iORR) by Investigator
Time frame: Up to approximately 24 months (107 weeks)
Immune Duration of Response (iDOR) by Investigator
Time frame: Up to approximately 28 months (122 weeks)
Immune Progression-free Survival (iPFS) by Investigator
Time frame: Up to 9 months (approximately 39 weeks)
Maximum Observed Serum Concentration
Time frame: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Area Under the Serum Concentration-Time Curve From Time Zero to the Last Quantifiable Time Point
Time frame: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity
Time frame: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Terminal Elimination Half-Life
Time frame: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Number of Participants With Immunogenicity as Measured by Anti-Qbeta Antibodies (ADA)
Time frame: Up to approximately 24 months (107 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Summary is available on TrialSummaries.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMP-001 and Nivolumab in people with Melanoma and Advanced Melanoma, run by Regeneron Pharmaceuticals at 25 sites 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 31 inclusion and 30 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: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 2 Apr 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?
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) (time frame: Up to approximately 24 months (107 weeks)). 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 11 Jun 2025.