NCT05608291

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,564 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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 an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drug (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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Fianlimab	Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
DRUG	Cemiplimab	Cemiplimab will be administered by IV infusion Q 3 weeks
DRUG	Pembrolizumab	Pembrolizumab will be administered by IV infusion Q 3 weeks
DRUG	Placebo	Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

Timeline

• Start date: 2023-01-16
• Primary completion: 2028-05-16
• Completion: 2030-02-15
• First posted: 2022-11-08
• Last updated: 2025-05-13

Locations

211 sites across 22 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Mexico, Poland, Romania, South Africa, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study