A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Status: Recruiting
Location: See all (101) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.

• Participants must not have received prior systemic therapy for unresectable or metastatic 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 or submitted sample for BRAF V600 mutation assessment as described in the protocol

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
Arizona Oncology Associates
WITHDRAWN
Tucson
California
Providence Medical Foundation
RECRUITING
Fullerton
Cancer and Blood Specialty Clinic
RECRUITING
Los Alamitos
University of California Los Angeles
RECRUITING
Los Angeles
St. Joseph Hospital Orange
RECRUITING
Orange
Eisenhower Medical Center
RECRUITING
Rancho Mirage
Sutter Health
RECRUITING
Sacramento
University of California San Francisco (UCSF)
RECRUITING
San Francisco
Sansum Clinic
RECRUITING
Santa Barbara
St John's Cancer Institute
RECRUITING
Santa Monica
Colorado
Rocky Mountain Regional VA Medical Center
RECRUITING
Aurora
University of Colorado Cancer Center
RECRUITING
Aurora
The Melanoma And Skin Cancer Institute
RECRUITING
Englewood
UCHealth
RECRUITING
Fort Collins
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Florida
Clermont Oncology Center
RECRUITING
Clermont
Cancer Specialist of North Florida
RECRUITING
Jacksonville
Mayo Clinic Florida
RECRUITING
Jacksonville
Boca Raton Clinical Research (BRCR) Global
RECRUITING
Tamarac
H. Lee Moffitt Cancer Center
RECRUITING
Tampa
Georgia
University Cancer & Blood Center
RECRUITING
Athens
John B. Amos Cancer Center
RECRUITING
Columbus
Idaho
Beacon Clinic
RECRUITING
Coeur D'alene
Illinois
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Illinois CancerCare
RECRUITING
Peoria
Indiana
Fort Wayne Medical Oncology and Hematology
RECRUITING
Fort Wayne
Kansas
The University of Kansas Cancer Center
RECRUITING
Westwood
Kentucky
Markey Cancer Center Clinical Research Organization
RECRUITING
Lexington
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Maryland
Maryland Oncology Hematology, P.A.
RECRUITING
Columbia
Michigan
University of Michigan
RECRUITING
Ann Arbor
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
Minnesota Oncology Hematology, P.A
RECRUITING
Fridley
Allina Health Cancer Institute
RECRUITING
Minneapolis
Missouri
Mercy South
RECRUITING
St Louis
VA St. Louis Healthcare System
RECRUITING
St Louis
Washington University
RECRUITING
St Louis
Montana
St. Vincent Healthcare
RECRUITING
Billings
North Carolina
Messino Cancer Center
RECRUITING
Asheville
Levine Cancer Institute
RECRUITING
Charlotte
Novant Health Cancer Institute
RECRUITING
Charlotte
Novant Health Weisiger Cancer Institute - Charlotte
RECRUITING
Charlotte
Duke Health System
RECRUITING
Durham
Novant Health Zimmer Cancer Institute - Wilmington
RECRUITING
Wilmington
Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
John Theurer Cancer Center
RECRUITING
Hackensack
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
The Valley Hospital Inc.
RECRUITING
Paramus
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
New York
New York Oncology Hematology
RECRUITING
Albany
Ohio
Oncology Hematology Care Clinical Trials
RECRUITING
Cincinnati
Seidman Cancer Center
RECRUITING
Cleveland
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC
RECRUITING
Tulsa
Oregon
Oncology Associates of Oregon PC
RECRUITING
Eugene
Kaiser Foundation Hospitals
RECRUITING
Portland
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
St. Luke's University Health Network
RECRUITING
Easton
Fox Chase Cancer Center
RECRUITING
Philadelphia
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
RECRUITING
Pittsburgh
Rhode Island
Lifespan Cancer Institute
RECRUITING
Providence
South Carolina
Saint Francis Cancer Center
RECRUITING
Greenville
Tennessee
Tennessee Oncology - Chattanooga
RECRUITING
Chattanooga
University of Tennessee Medical Center
RECRUITING
Knoxville
Sarah Cannon Research Institute (SCRI) Oncology Partners
RECRUITING
Nashville
Tennessee Oncology
RECRUITING
Nashville
Texas
Texas Oncology - Austin Central, Central Austin Cancer Center
RECRUITING
Austin
Texas Oncology - Austin Midtown, Midtown Medical Center I
RECRUITING
Austin
Texas Oncology - Bedford
RECRUITING
Bedford
Texas Oncology
RECRUITING
Dallas
Texas Oncology - Medical City
RECRUITING
Dallas
Center For Disease And Blood Disorder
RECRUITING
Fort Worth
Texas Oncology - Fort Worth
RECRUITING
Fort Worth
Texas Oncology - Grapevine
RECRUITING
Grapevine
Texas Oncology - Harlingen, Medical Arts Pavillion
RECRUITING
Harlingen
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Texas Oncology - Longview
RECRUITING
Longview
Joe Arrington Cancer Research & Treatment Center
RECRUITING
Lubbock
Texas Oncology - McAllen
RECRUITING
Mcallen
Texas Oncology-Palestine Cancer Center
RECRUITING
Palestine
Texas Oncology-Tyler, Northeast Texas Cancer Institute
RECRUITING
Tyler
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
RECRUITING
Tyler
Texas Oncology - Weslaco, Knapp Medical Plaza
RECRUITING
Weslaco
Utah
University of Utah Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Virginia Commonwealth University Massey Cancer Center
RECRUITING
Richmond
Oncology & Hematology Associates of Southwest Virginia, Inc.
RECRUITING
Roanoke
Washington
Swedish Cancer Institute - Edmonds Campus
RECRUITING
Edmonds
Swedish Cancer Institute - Issaquah Campus
RECRUITING
Issaquah
Swedish Cancer Institute
RECRUITING
Seattle
Wisconsin
University of Wisconsin Carbone Cancer Center
RECRUITING
Madison
West Virginia
West Virginia University
RECRUITING
Morgantown
Other Locations
Canada
London Regional Cancer Centre
RECRUITING
London
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2033-07-10
Participants
Target number of participants: 560
Treatments
Experimental: fianlimab+cemiplimab
Randomized 1:1
Active_comparator: relatlimab+nivolumab
Randomized 1:1
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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