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RECRUITINGPhase 3INTERVENTIONAL

A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)

Who May Be Eligible (Plain English)

Key Who May Qualify: 1. Participants with diagnosed by tissue sample (biopsy-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 previous cancer treatment that works throughout the body (like chemotherapy) for unresectable or metastatic melanoma as described in the protocol. 3. tumors that can be measured on scans 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 Who Should NOT Join This Trial: Medical Conditions: 1. Uveal, acral or mucosal melanoma. 2. Ongoing or recent (within 2 years) evidence of an autoimmune conditions (where your immune system attacks your own body) that required systemic treatment with immunosuppressive agents as described in the protocol. 3. Uncontrolled infection with human weakened immune system virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of weakened immune system that is related to, or results in chronic infection. Mild cancer-related weakened immune system (such as weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

fianlimab

Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab

DRUG

cemiplimab

IV administration Q3W in combination with fianlimab

DRUG

relatlimab+nivolumab

IV administration every 4 weeks (Q4W)

Locations (20)

Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
University of California Los Angeles
Los Angeles, California, United States
St. Joseph Hospital Orange
Orange, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Emad Ibrahim, MD, Inc.
Redlands, California, United States
Sutter Health
Sacramento, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Sansum Clinic
Santa Barbara, California, United States
St John's Cancer Institute
Santa Monica, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
The Melanoma And Skin Cancer Institute
Englewood, Colorado, United States
UCHealth
Fort Collins, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Clermont Oncology Center
Clermont, Florida, United States