Home › Melanoma › NCT06246916
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)
RecruitingPhase 3
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the study
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)
What is being tested
- fianlimab (drug)
- cemiplimab (drug)
- relatlimab+nivolumab (drug)
Sponsor: Regeneron Pharmaceuticals · Participants: 560 · Started: Sep 9, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06246916
Locations in the U.S.
| Arizona | Ironwood Cancer & Research Centers, Chandler Banner MD Anderson Cancer Center, Gilbert |
| Arkansas | University of Arkansas for Medical Sciences, Little Rock |
| California | Providence Medical Foundation, Fullerton Cancer and Blood Specialty Clinic, Los Alamitos University of California Los Angeles, Los Angeles St. Joseph Hospital Orange, Orange University of California Irvine, UCI Medical Center, Orange Emad Ibrahim, MD, Inc., Redlands Sutter Health, Sacramento University of California San Francisco (UCSF), San Francisco St John's Cancer Institute, Santa Monica |
| Colorado | Rocky Mountain Regional VA Medical Center, Aurora University of Colorado Cancer Center, Aurora The Melanoma And Skin Cancer Institute, Englewood |
| Connecticut | Yale Cancer Center, New Haven |
| Florida | Mayo Clinic Florida, Jacksonville Boca Raton Clinical Research (BRCR) Global, Tamarac H. Lee Moffitt Cancer Center, Tampa |
| Georgia | University Cancer & Blood Center, Athens |
| Idaho | Beacon Clinic, Coeur d'Alene |
| Illinois | Hope and Healing Cancer Services, Hinsdale Advocate Lutheran General Hospital, Park Ridge Illinois CancerCare, Peoria |
| Indiana | Fort Wayne Medical Oncology and Hematology, Fort Wayne |
| Kansas | The University of Kansas Cancer Center, Westwood |
| Kentucky | Markey Cancer Center Clinical Research Organization, Lexington |
| Louisiana | Mary Bird Perkins Cancer Center, Baton Rouge |
| Maryland | Maryland Oncology Hematology, P.A., Columbia |
| Michigan | University of Michigan, Ann Arbor Henry Ford Cancer Institute/Henry Ford Health System, Detroit |
| Minnesota | Minnesota Oncology Hematology, P.A, Fridley Allina Health Cancer Institute, Minneapolis |
| Missouri | Mercy South, St Louis VA St. Louis Healthcare System, St Louis Washington University School of Medicine, St Louis |
| Nebraska | Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha |
| Nevada | Comprehensive Cancer Centers of Nevada, Las Vegas |
| New Hampshire | Dartmouth Hitchcock Medical Center, Lebanon |
| New Jersey | John Theurer Cancer Center, Hackensack Rutgers Cancer Institute of New Jersey, New Brunswick The Valley Hospital Inc., Paramus |
| New York | New York Oncology Hematology, Albany |
| North Carolina | Messino Cancer Center, Asheville Levine Cancer Institute, Charlotte Novant Health Cancer Institute, Charlotte Novant Health Weisiger Cancer Institute - Charlotte, Charlotte Duke Health System, Durham Novant Health Zimmer Cancer Institute - Wilmington, Wilmington |
| Ohio | Oncology Hematology Care Clinical Trials, Cincinnati Seidman Cancer Center, Cleveland The Ohio State University Wexner Medical Center, Columbus |
| Oklahoma | Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa |
| Oregon | USOR Willamette Valley Cancer Institute and Research Center, Eugene Kaiser Foundation Hospitals, Portland Oregon Health and Science University, Portland |
| Pennsylvania | St. Luke's University Health Network, Easton Penn State Health Milton South Hershey Medical Center, Hershey Fox Chase Cancer Center, Philadelphia University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Pittsburgh |
| Rhode Island | Lifespan Cancer Institute, Providence |
| Tennessee | Tennessee Oncology - Chattanooga, Chattanooga University of Tennessee Medical Center, Knoxville Sarah Cannon Research Institute (SCRI) Oncology Partners, Nashville Tennessee Oncology, Nashville |
| Texas | Texas Oncology - Austin Central, Central Austin Cancer Center, Austin Texas Oncology - Austin Midtown, Midtown Medical Center I, Austin Texas Oncology - South Austin, South Austin Cancer Center, Austin Texas Oncology - Bedford, Bedford Texas Oncology, Dallas Texas Oncology - Medical City, Dallas Center For Disease And Blood Disorder, Fort Worth Texas Oncology - Fort Worth, Fort Worth Texas Oncology - Grapevine, Grapevine Texas Oncology - Harlingen, Medical Arts Pavillion, Harlingen The University of Texas MD Anderson Cancer Center, Houston Texas Oncology - Longview, Longview Joe Arrington Cancer Research & Treatment Center, Lubbock Texas Oncology - McAllen, McAllen Texas Oncology-Palestine Cancer Center, Palestine Texas Oncology - Weslaco, Knapp Medical Plaza, Weslaco |
| Utah | University of Utah Huntsman Cancer Institute, Salt Lake City |
| Virginia | University of Virginia, Charlottesville Inova Schar Cancer Institute, Fairfax Virginia Commonwealth University Massey Cancer Center, Richmond Oncology & Hematology Associates of Southwest Virginia, Inc., Roanoke |
| Washington | Swedish Cancer Institute - Edmonds Campus, Edmonds Swedish Cancer Institute - Issaquah Campus, Issaquah Kadlec Clinic Hematology and Oncology, Kennewick Swedish Cancer Institute, Seattle |
| West Virginia | West Virginia University, Morgantown |
| Wisconsin | University of Wisconsin Carbone Cancer Center, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.