Phase
Condition
Melanoma
Treatment
cemiplimab
relatlimab+nivolumab
fianlimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revisededition.
Participants must not have received prior systemic therapy for unresectable ormetastatic melanoma as described in the protocol.
Measurable disease per RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
Adequate bone marrow, hepatic, and kidney function
Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status orsubmitted sample for BRAF V600 mutation assessment as described in the protocol
Exclusion
Key Exclusion Criteria:
Medical Conditions:
Uveal, acral or mucosal melanoma.
Ongoing or recent (within 2 years) evidence of an autoimmune disease that requiredsystemic treatment with immunosuppressive agents as described in the protocol.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV),or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that isrelated to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic orrecurrent infection) is allowed. Prior/Concomitant Therapy:
Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described inthe protocol
Systemic immune suppression as described in the protocol. Other Comorbidities:
Participants with a history of myocarditis.
Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).
Active or untreated brain metastases or spinal cord compression as described in theprotocol.
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Study Design
Connect with a study center
London Regional Cancer Centre
London, Ontario N6A 5W9
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, G1G 5X1
CanadaActive - Recruiting
Ironwood Cancer & Research Centers
Chandler, Arizona 85224
United StatesActive - Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United StatesActive - Recruiting
Arizona Oncology Associates
Tucson, Arizona 85711
United StatesActive - Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesActive - Recruiting
UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
Eisenhower Medical Center
Rancho Mirage, California 92270
United StatesActive - Recruiting
Sutter Health
Sacramento, California 95816
United StatesActive - Recruiting
UCSF
San Francisco, California 94143
United StatesActive - Recruiting
Sansum Clinic
Santa Barbara, California 93105
United StatesActive - Recruiting
St John's Cancer Institute
Santa Monica, California 90404
United StatesActive - Recruiting
Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
United StatesActive - Recruiting
The Melanoma And Skin Cancer Institute
Englewood, Colorado 80113
United StatesActive - Recruiting
UCHealth
Fort Collins, Colorado 80528
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06510
United StatesActive - Recruiting
Clermont Oncology Center
Clermont, Florida 34711
United StatesActive - Recruiting
Cancer Specialist of North Florida
Jacksonville, Florida 32256
United StatesActive - Recruiting
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida 33322
United StatesActive - Recruiting
H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
John B. Amos Cancer Center
Columbus, Georgia 31904
United StatesActive - Recruiting
Beacon Clinic
Coeur d'Alene, Idaho 83815
United StatesActive - Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
United StatesActive - Recruiting
Illinois CancerCare
Peoria, Illinois 61615
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46825-1623
United StatesActive - Recruiting
The University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesActive - Recruiting
Markey Cancer Center Clinical Research Organization
Lexington, Kentucky 40536-0093
United StatesActive - Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
Maryland Oncology Hematology, P.A.
Columbia, Maryland 21044
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Minnesota Oncology Hematology, P.A
Fridley, Minnesota 55424
United StatesActive - Recruiting
Allina Health Cancer Institute
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Mercy South
Saint Louis, Missouri 63128
United StatesActive - Recruiting
VA St. Louis Healthcare System
Saint Louis, Missouri 63106
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
St. Vincent Healthcare
Billings, Montana 59102
United StatesActive - Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
Regeneron Study Facility
Omaha, Nebraska 68130
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada - Southwest
Las Vegas, Nevada 89148
United StatesActive - Recruiting
John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United StatesActive - Recruiting
New York Oncology Hematology
Albany, New York 12206
United StatesActive - Recruiting
Messino Cancer Center
Asheville, North Carolina 28806
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Seidman Cancer Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma 74146
United StatesActive - Recruiting
Kaiser Foundation Hospitals
Portland, Oregon 97227
United StatesActive - Recruiting
St. Luke's University Health Network
Easton, Pennsylvania 18045
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesActive - Recruiting
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Lifespan Cancer Institute
Providence, Rhode Island 02903
United StatesActive - Recruiting
Saint Francis Cancer Center
Greenville, South Carolina 29607
United StatesActive - Recruiting
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology
Nashville, Tennessee 37203
United StatesActive - Recruiting
Texas Oncology - Austin Central, Central Austin Cancer Center
Austin, Texas 78731
United StatesActive - Recruiting
Center For Disease And Blood Disorder
Fort Worth, Texas 76104
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas 79410
United StatesActive - Recruiting
Texas Oncology-Tyler, Northeast Texas Cancer Institute
Tyler, Texas 75702
United StatesActive - Recruiting
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Tyler, Texas 75701
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesActive - Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23298
United StatesActive - Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia 24014
United StatesActive - Recruiting
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington 98026
United StatesActive - Recruiting
Swedish Cancer Institute - Issaquah Campus
Issaquah, Washington 98029
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle, Washington 98104-3551
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26506
United StatesActive - Recruiting
West Virginia University (Please Use)
Morgantown, West Virginia 26506
United StatesActive - Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
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