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 (NCT06190951)
A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UC San Diego — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (104 Sites)
Showing the first 25 of 104 sites.
- UC San Diego — La Jolla, California
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- Hoag Family Cancer Institute — Newport Beach, California
- California Pacific Medical Center Research Institute — San Francisco, California
- University of California San Francisco (UCSF) — San Francisco, California
- St John's Cancer Institute — Santa Monica, California
- University of Colorado Cancer Center — Aurora, Colorado
- Hartford Hospital — Hartford, Connecticut
- Yale University Cancer Center — New Haven, Connecticut
- Emory Healthcare, Emory Clinic — Atlanta, Georgia
- NorthShore University HealthSystem — Evanston, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute Brookline Avenue — Boston, Massachusetts
- University of Massachusetts Chan Medical School — Worcester, Massachusetts
- Washington University School of Medicine — St Louis, Missouri
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Northwell Health Cancer Institute — Lake Success, New York
- Duke Cancer Institute, University Hospital — Durham, North Carolina
- Seidman Cancer Center — Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio
- The Ohio State University James Comprehensive Cancer Center — Columbus, Ohio
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania
- University of Tennessee Medical Center — Knoxville, Tennessee
- UT Southwestern/Simmons Comprehensive Cancer Center — Dallas, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma
- Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
- An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) — Tucson, Arizona
- Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. — CABA, Buenos Aires
- Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients — Santa Monica, California
- NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma — Boston, Massachusetts
- A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma — Orlando, Florida
Explore by condition: All Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.