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A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
University of California Los Angeles
Los Angeles, California, United States
St. Joseph Hospital Orange
Orange, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Emad Ibrahim, MD, Inc.
Redlands, California, United States
Start Date
September 9, 2024
Primary Completion Date
March 22, 2027
Completion Date
July 10, 2033
Last Updated
February 19, 2026
560
ESTIMATED participants
fianlimab
DRUG
cemiplimab
DRUG
relatlimab+nivolumab
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
NCT06066138
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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