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 5289282, Arizona 5551752 85224
Gilbert 5295903, Arizona 5551752 85234
Tucson 5318313, Arizona 5551752 85711
Little Rock 4119403, Arkansas 4099753 72205
Fullerton 5351247, California 5332921 92835
Los Alamitos 5368304, California 5332921 90720
Los Angeles 5368361, California 5332921 90095
Orange 5379513, California 5332921 92868
Rancho Mirage 5386015, California 5332921 92270
Sacramento 5389489, California 5332921 95816
San Francisco 5391959, California 5332921 94143
Santa Barbara 5392952, California 5332921 93105
Santa Monica 5393212, California 5332921 90404
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Englewood 5421250, Colorado 5417618 80113
Fort Collins 5577147, Colorado 5417618 80528
New Haven 4839366, Connecticut 4831725 06510
Clermont 4151352, Florida 4155751 34711
Jacksonville 4160021, Florida 4155751 32224
Jacksonville 4160021, Florida 4155751 32256
Tamarac 4174738, Florida 4155751 33321
Tampa 4174757, Florida 4155751 33612
Athens 4180386, Georgia 4197000 30607
Columbus 4188985, Georgia 4197000 31904
Coeur d'Alene 5589173, Idaho 5596512 83815
Hinsdale 4896012, Illinois 4896861 60521
Park Ridge 4905367, Illinois 4896861 60068
Peoria 4905687, Illinois 4896861 61615
Fort Wayne 4920423, Indiana 4921868 46825-1623
Westwood 4281639, Kansas 4273857 66205
Lexington 4297983, Kentucky 6254925 40536-0093
Baton Rouge 4315588, Louisiana 4331987 70809
Columbia 4352053, Maryland 4361885 21044
Ann Arbor 4984247, Michigan 5001836 48109
Detroit 4990729, Michigan 5001836 48201
Fridley 5027482, Minnesota 5037779 55432
Minneapolis 5037649, Minnesota 5037779 55407
St Louis 4407066, Missouri 4398678 63106
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63128
Billings 5640350, Montana 5667009 59102
Omaha 5074472, Nebraska 5073708 68130
Las Vegas 5506956, Nevada 5509151 89148
Hackensack 5098706, New Jersey 5101760 07601
New Brunswick 5101717, New Jersey 5101760 08901
Paramus 5102387, New Jersey 5101760 07652
Albany 5106834, New York 5128638 12206
Asheville 4453066, North Carolina 4482348 28806
Charlotte 4460243, North Carolina 4482348 28204
Charlotte 4460243, North Carolina 4482348 28204
Charlotte 4460243, North Carolina 4482348 28204
Durham 4464368, North Carolina 4482348 27710
Wilmington 4499379, North Carolina 4482348 28401
Cincinnati 4508722, Ohio 5165418 45242
Cleveland 5150529, Ohio 5165418 44106
Tulsa 4553433, Oklahoma 4544379 74146
Eugene 5725846, Oregon 5744337 97401
Portland 5746545, Oregon 5744337 97227
Portland 5746545, Oregon 5744337 97239
Easton 5188140, Pennsylvania 6254927 18045
Philadelphia 4560349, Pennsylvania 6254927 19111
Pittsburgh 5206379, Pennsylvania 6254927 15232
Providence 5224151, Rhode Island 5224323 02903
Greenville 4580543, South Carolina 4597040 29607
Chattanooga 4612862, Tennessee 4662168 37404
Knoxville 4634946, Tennessee 4662168 37920
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Austin 4671654, Texas 4736286 78705
Austin 4671654, Texas 4736286 78731
Bedford 4673094, Texas 4736286 76022
Dallas 4684888, Texas 4736286 75230
Dallas 4684888, Texas 4736286 75246
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
Grapevine 4694568, Texas 4736286 76051
Harlingen 4696233, Texas 4736286 78550
Houston 4699066, Texas 4736286 77030
Longview 4707814, Texas 4736286 75601
Lubbock 5525577, Texas 4736286 79410
McAllen 4709796, Texas 4736286 78503
Palestine 4717232, Texas 4736286 75801
Tyler 4738214, Texas 4736286 75701
Tyler 4738214, Texas 4736286 75702
Weslaco 4740629, Texas 4736286 78596
Salt Lake City 5780993, Utah 5549030 84112
Charlottesville 4752031, Virginia 6254928 22908
Fairfax 4758023, Virginia 6254928 22031
Norfolk 4776222, Virginia 6254928 23502
Richmond 4781708, Virginia 6254928 23298
Roanoke 4782167, Virginia 6254928 24014
Edmonds 5793427, Washington 5815135 98026
Issaquah 5798487, Washington 5815135 98029
Seattle 5809844, Washington 5815135 98104-3551
Morgantown 4815352, West Virginia 4826850 26506
Madison 5261457, Wisconsin 5279468 53792
More Details
- NCT ID
- NCT06246916
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals