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)
Recruiting now · Phase 3
Conditions studied: Melanoma
In brief
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)
Key facts
- Study ID
- NCT06246916
- Run by
- Regeneron Pharmaceuticals
- People needed
- 560
- Starts
- 2024-09-09
- Expected to finish
- 2033-07-10
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Advocate Lutheran General Hospital — Park Ridge, Illinois, United States (enrolling)
- Illinois CancerCare — Peoria, Illinois, United States (enrolling)
- University Cancer & Blood Center — Athens, Georgia, United States (enrolling)
- Hope and Healing Cancer Services — Hinsdale, Illinois, United States (enrolling)
- Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
- Ironwood Cancer & Research Centers — Chandler, Arizona, United States (enrolling)
- St. Joseph Hospital Orange — Orange, California, United States (enrolling)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
- Beacon Clinic — Coeur d'Alene, Idaho, United States (enrolling)
- Sutter Health — Sacramento, California, United States (enrolling)
- University of California San Francisco (UCSF) — San Francisco, California, United States (enrolling)
- University of California Los Angeles — Los Angeles, California, United States (enrolling)
- St John's Cancer Institute — Santa Monica, California, United States (enrolling)
- Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States (enrolling)
- University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
- The Melanoma And Skin Cancer Institute — Englewood, Colorado, United States (enrolling)
- University of California Irvine, UCI Medical Center — Orange, California, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Providence Medical Foundation — Fullerton, California, United States (enrolling)
- Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
- Emad Ibrahim, MD, Inc. — Redlands, California, United States (enrolling)
- Boca Raton Clinical Research (BRCR) Global — Tamarac, Florida, United States (enrolling)
- H. Lee Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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