A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Melanoma
In brief
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug(s). * How much study drug(s) is in the blood at different times. * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.
Key facts
- Study ID
- NCT06190951
- Run by
- Regeneron Pharmaceuticals
- People needed
- 151
- Starts
- 2024-09-18
- Expected to finish
- 2030-12-09
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Hoag Family Cancer Institute — Newport Beach, California, United States
- California Pacific Medical Center Research Institute — San Francisco, California, United States
- University of California San Francisco (UCSF) — San Francisco, California, United States
- St John's Cancer Institute — Santa Monica, California, United States
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Hartford Hospital — Hartford, Connecticut, United States
- Yale University Cancer Center — New Haven, Connecticut, United States
- Emory Healthcare, Emory Clinic — Atlanta, Georgia, United States
- NorthShore University HealthSystem — Evanston, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana Farber Cancer Institute Brookline Avenue — Boston, Massachusetts, United States
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Northwell Health Cancer Institute — Lake Success, New York, United States
- Duke Cancer Institute, University Hospital — Durham, North Carolina, United States
- Seidman Cancer Center — Cleveland, Ohio, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- The Ohio State University James Comprehensive Cancer Center — Columbus, Ohio, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- University of Tennessee Medical Center — Knoxville, Tennessee, United States
- UT Southwestern/Simmons Comprehensive Cancer Center — Dallas, Texas, United States
- UC San Diego — La Jolla, California, United States
Full record on ClinicalTrials.gov
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