Combining two experimental drugs for advanced melanoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of fianlimab and cemiplimab, two experimental drugs, in treating advanced or metastatic melanoma. Participants will be compared against a control group receiving relatlimab and nivolumab, a currently approved treatment. The study will also assess side effects, drug levels in the blood, and the body's immune response to the drugs. The goal is to determine if the new combination offers any advantages over existing therapies.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
3. Measurable disease per RECIST version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
5. Adequate bone marrow, hepatic, and kidney function
6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol

Key Exclusion Criteria:

Medical Conditions:

1. Uveal, acral or mucosal melanoma.
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.

   Prior/Concomitant Therapy:
4. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
5. Systemic immune suppression as described in the protocol.

   Other Comorbidities:
6. Participants with a history of myocarditis.
7. Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
8. Active or untreated brain metastases or spinal cord compression as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Where it's running

• Ironwood Cancer & Research Centers
  Chandler, Arizona, United States Recruiting
• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• Providence Medical Foundation
  Fullerton, California, United States Recruiting
• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• St. Joseph Hospital Orange
  Orange, California, United States Recruiting

+63 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• First-line immune-checkpoint antibody combinations for advanced clear cell kidney cancer

  This trial tests whether combining fianlimab and cemiplimab, with or without ipilimumab, works better than the standard ipilimumab plus nivolumab as first treatment for people with advanced clear cell kidney cancer.

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• Relatlimab, nivolumab, and ipilimumab for melanoma that has spread to the brain

  This trial will test whether the combination of relatlimab, nivolumab, and ipilimumab can help adults with melanoma brain metastases, including those with and without symptoms.

  Recruiting Phase 2 Stanford University · Palo Alto, California · NCT06712927

• Triplet combination of Relatlimab, Nivolumab, and Ipilimumab in first-line metastatic melanoma

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• Combining Sarilumab with Other Treatments for Advanced Melanoma

  This study is testing a new combination of treatments for people with advanced melanoma to see if it helps them feel better and live longer.

  Recruiting at 4 sites Phase 2 NYU Langone Health · Los Angeles, California and 3 other locations · NCT05428007

• Using ctDNA to decide whether to add ipilimumab for people on nivolumab and relatlimab

  This tests whether using a ctDNA blood test to guide adding ipilimumab for adults with advanced or metastatic melanoma on nivolumab and relatlimab leads to longer progression-free survival.

  Recruiting Phase 2 NYU Langone Health · New York, New York · NCT07504796

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.