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
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
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:
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Caba, Buenos Aires 1125, Argentina
Caba, 1061, Argentina
Blacktown, New South Wales 2148, Australia
Belo Horizonte, Minas Gerais 30130-090, Brazil
Passo Fundo, Rio Grande do Sul 99010-090, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Tbilisi, Caucasus 0144, Georgia
Kiel, Schleswig-Holstein 24105, Germany
Naples, Campania 80121, Italy
Gdansk, Pomeranian Voivodeship 80-219, Poland
Słupsk, Pomeranian Voivodeship 76-200, Poland
Barcelona, Catalonia 08028, Spain
Istanbul, 81450, Turkey (Türkiye)
Bristol, Somerset BS2 8ED, United Kingdom
Coventry, West Midlands CV2 2DX, United Kingdom