Home › Trials › NCT06246916

Combining two experimental drugs for advanced melanoma treatment

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Phase 3 Interventional Regeneron Pharmaceuticals · NCT06246916

This study is testing if a new combination of two experimental drugs can help people with advanced melanoma more than the current approved treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment560 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsfianlimab, cemiplimab, relatlimab, nivolumab
Locations109 sites (Chandler, Arizona and 108 other locations)
Trial IDNCT06246916 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable stage III or IV melanoma who have not received prior systemic therapy for their condition.

Not a fit: Patients with uveal, acral, or mucosal melanoma, or those with uncontrolled infections or recent autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promise with similar immunotherapy combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 108 other locations

+59 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MelanomaUnresectable MelanomaMetastatic MelanomaAdvanced MelanomaStage IIIStage IV
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.