Actively Recruiting
Phase 3 Study of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Adults With Unresectable or Metastatic Melanoma
Led by Regeneron Pharmaceuticals · Updated on 2026-05-06
560
Participants Needed
109
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an experimental drug called fianlimab, combined with cemiplimab, in treating adults with advanced or metastatic melanoma, a type of skin cancer. This study compares the combination of fianlimab and cemiplimab with an approved treatment combining relatlimab and nivolumab. The study also investigates side effects, drug levels in the blood, and whether the body produces antibodies against the study drugs. Participants receive either fianlimab and cemiplimab every three weeks through intravenous infusion or the combination of relatlimab and nivolumab every four weeks intravenously. The study is randomized with two groups receiving one of these treatments. This is a phase 3 trial designed to gather detailed information about how these drug combinations work in melanoma treatment. During the study, participants will be regularly monitored for tumor response using standard criteria, side effects, survival, and immune responses for up to 72 months. Tests include blood samples to measure drug concentration and antibody formation. Safety evaluations and disease progression assessments will be done throughout the study period to understand the treatments' effects over time.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically confirmed unresectable stage III or stage IV metastatic melanoma
- No prior systemic therapy for unresectable or metastatic melanoma
- Measurable disease according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver, and kidney function
- Known or submitted sample for BRAF V600 mutation status testing
You will not qualify if you...
- Diagnosis of uveal, acral, or mucosal melanoma
- Active or recent autoimmune disease requiring systemic immunosuppressive treatment within 2 years
- Uncontrolled infection with HIV, hepatitis B, or hepatitis C, or related immunodeficiency
- Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1
- Current systemic immune suppression
- History of myocarditis
- Elevated troponin T or I levels greater than twice the normal limit
- Active or untreated brain metastases or spinal cord compression
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 months
Participants receive intravenous administration of study drugs every 3 or 4 weeks depending on their assigned group.
Infusions every 3 or 4 weeks
Duration - Up to 72 months
After completing treatment, participants are monitored for up to 72 months to assess outcomes and safety.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 109 locations
1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
Withdrawn
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
5
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
6
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
7
University of California Los Angeles
Los Angeles, California, United States, 90024
Actively Recruiting
8
St. Joseph Hospital Orange
Orange, California, United States, 92868
Actively Recruiting
9
University of California Irvine, UCI Medical Center
Orange, California, United States, 92868
Actively Recruiting
10
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Withdrawn
11
Emad Ibrahim, MD, Inc.
Redlands, California, United States, 92373
Actively Recruiting
12
Sutter Health
Sacramento, California, United States, 95816
Actively Recruiting
13
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
Actively Recruiting
14
Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
15
St John's Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
16
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States, 80045
Actively Recruiting
17
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
18
The Melanoma And Skin Cancer Institute
Englewood, Colorado, United States, 80113
Actively Recruiting
19
UCHealth
Fort Collins, Colorado, United States, 80528
Withdrawn
20
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
21
Clermont Oncology Center
Clermont, Florida, United States, 34711
Actively Recruiting
22
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
23
Cancer Specialist of North Florida
Jacksonville, Florida, United States, 32256
Actively Recruiting
24
Boca Raton Clinical Research (BRCR) Global
Tamarac, Florida, United States, 33321
Actively Recruiting
25
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
26
University Cancer & Blood Center
Athens, Georgia, United States, 30607
Actively Recruiting
27
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Withdrawn
28
Beacon Clinic
Coeur d'Alene, Idaho, United States, 83815
Actively Recruiting
29
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
30
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
31
Illinois CancerCare
Peoria, Illinois, United States, 61615
Actively Recruiting
32
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46825
Actively Recruiting
33
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
34
Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, United States, 40536
Actively Recruiting
35
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
36
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
Actively Recruiting
37
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
38
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Withdrawn
39
Henry Ford Cancer Institute/Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
40
Minnesota Oncology Hematology, P.A
Fridley, Minnesota, United States, 55432
Actively Recruiting
41
Allina Health Cancer Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
42
VA St. Louis Healthcare System
St Louis, Missouri, United States, 63106
Actively Recruiting
43
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
44
Mercy South
St Louis, Missouri, United States, 63128
Actively Recruiting
45
St. Vincent Healthcare
Billings, Montana, United States, 59102
Actively Recruiting
46
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
47
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Actively Recruiting
48
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
49
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
50
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
51
The Valley Hospital Inc.
Paramus, New Jersey, United States, 07652
Actively Recruiting
52
New York Oncology Hematology
Albany, New York, United States, 12206
Actively Recruiting
53
Messino Cancer Center
Asheville, North Carolina, United States, 28806
Actively Recruiting
54
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
55
Novant Health Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
56
Novant Health Weisiger Cancer Institute - Charlotte
Charlotte, North Carolina, United States, 28204
Actively Recruiting
57
Duke Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
58
Novant Health Zimmer Cancer Institute - Wilmington
Wilmington, North Carolina, United States, 28401
Actively Recruiting
59
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States, 45242
Actively Recruiting
60
Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
61
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
62
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
63
Oncology Associates of Oregon PC
Eugene, Oregon, United States, 97401
Actively Recruiting
64
Kaiser Foundation Hospitals
Portland, Oregon, United States, 97227
Actively Recruiting
65
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
66
St. Luke's University Health Network
Easton, Pennsylvania, United States, 18045
Actively Recruiting
67
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
68
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
69
Lifespan Cancer Institute
Providence, Rhode Island, United States, 02903
Actively Recruiting
70
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Withdrawn
71
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
72
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
73
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
74
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
75
Texas Oncology - Austin Midtown, Midtown Medical Center I
Austin, Texas, United States, 78705
Actively Recruiting
76
Texas Oncology - Austin Central, Central Austin Cancer Center
Austin, Texas, United States, 78731
Actively Recruiting
77
Texas Oncology - Bedford
Bedford, Texas, United States, 76022
Actively Recruiting
78
Texas Oncology - Medical City
Dallas, Texas, United States, 75230
Actively Recruiting
79
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
80
Center For Disease And Blood Disorder
Fort Worth, Texas, United States, 76104
Actively Recruiting
81
Texas Oncology - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
82
Texas Oncology - Grapevine
Grapevine, Texas, United States, 76051
Actively Recruiting
83
Texas Oncology - Harlingen, Medical Arts Pavillion
Harlingen, Texas, United States, 78550
Actively Recruiting
84
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
85
Texas Oncology - Longview
Longview, Texas, United States, 75601
Actively Recruiting
86
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, United States, 79410
Actively Recruiting
87
Texas Oncology - McAllen
McAllen, Texas, United States, 78503
Actively Recruiting
88
Texas Oncology-Palestine Cancer Center
Palestine, Texas, United States, 75801
Actively Recruiting
89
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States, 75701
Withdrawn
90
Texas Oncology-Tyler, Northeast Texas Cancer Institute
Tyler, Texas, United States, 75702
Actively Recruiting
91
Texas Oncology - Weslaco, Knapp Medical Plaza
Weslaco, Texas, United States, 78596
Actively Recruiting
92
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
93
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
94
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
95
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
96
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
97
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
98
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
Actively Recruiting
99
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, United States, 98026
Actively Recruiting
100
Swedish Cancer Institute - Issaquah Campus
Issaquah, Washington, United States, 98029
Actively Recruiting
101
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Actively Recruiting
102
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
103
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
104
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
105
London Regional Cancer Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
106
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
107
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
108
Jewish General Hospital - Main Address
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
109
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1J 0J9
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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