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)
Purpose
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)
Condition
- Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental fianlimab+cemiplimab |
Randomized 1:1 |
|
|
Active Comparator relatlimab+nivolumab |
Randomized 1:1 |
|
Recruiting Locations
Chandler, Arizona 85224
Gilbert, Arizona 85234
Tucson, Arizona 85711
Little Rock, Arkansas 72205
Los Alamitos, California 90720
Los Angeles, California 90095
Rancho Mirage, California 92270
Sacramento, California 95816
San Francisco, California 94143
Santa Barbara, California 93105
Santa Monica, California 90404
Aurora, Colorado 80045
Aurora, Colorado 80045
Englewood, Colorado 80113
Fort Collins, Colorado 80528
New Haven, Connecticut 06510
Clermont, Florida 34711
Jacksonville, Florida 32256
Tamarac, Florida 33321
Tampa, Florida 33612
Columbus, Georgia 31904
Coeur d'Alene, Idaho 83815
Hinsdale, Illinois 60521
Park Ridge, Illinois 60068
Peoria, Illinois 61615
Fort Wayne, Indiana 46825-1623
Westwood, Kansas 66205
Lexington, Kentucky 40536-0093
Baton Rouge, Louisiana 70809
Columbia, Maryland 21044
Detroit, Michigan 48201
Fridley, Minnesota 55424
Minneapolis, Minnesota 55407
Saint Louis, Missouri 63106
Saint Louis, Missouri 63110
Saint Louis, Missouri 63128
Billings, Montana 59102
Omaha, Nebraska 68130
Las Vegas, Nevada 89148
Hackensack, New Jersey 07601
New Brunswick, New Jersey 08903
Paramus, New Jersey 07652
Albany, New York 12206
Asheville, North Carolina 28806
Charlotte, North Carolina 28204
Cincinnati, Ohio 45242
Cleveland, Ohio 44106
Tulsa, Oklahoma 74146
Eugene, Oregon 97401
Portland, Oregon 97227
Easton, Pennsylvania 18045
Philadelphia, Pennsylvania 19111
Pittsburgh, Pennsylvania 15232
Providence, Rhode Island 02903
Greenville, South Carolina 29607
Chattanooga, Tennessee 37404
Knoxville, Tennessee 37920
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Austin, Texas 78731
Dallas, Texas 75246
Fort Worth, Texas 76104
Houston, Texas 77030
Lubbock, Texas 79410
Tyler, Texas 75701
Tyler, Texas 75702
Salt Lake City, Utah 84112
Charlottesville, Virginia 22908
Fairfax, Virginia 22031
Norfolk, Virginia 23502
Richmond, Virginia 23298
Roanoke, Virginia 24014
Edmonds, Washington 98026
Issaquah, Washington 98029
Seattle, Washington 98104-3551
Morgantown, West Virginia 26506
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT06246916
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals