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

Brief description of study

This is a randomized, double-blind, phase 3 study in patients 12 years of age or older with completely resected high-risk melanoma in the adjuvant setting. There are 3 arms in the study. The study will enroll a total of approximately 1,530 patients, randomized 1:1:1. The study will be conducted globally, at approximately 200 sites in Europe, North America, Latin America (LATAM), and Australia. Patients will have had no prior systemic therapy for melanoma and have fully resected melanoma, of stages IIC, III or IV (American Joint Committee on Cancer [AJCC] v8). The trial will be stratified by the disease stage and geographical region. The study will be blinded, except for an unblinded pharmacist at each site. Primary Objective is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse-free survival (RFS).


Clinical Study Identifier: s22-01563
ClinicalTrials.gov Identifier: NCT05608291
Principal Investigator: Janice Mehnert.
Other Investigators: Nila Theresa De La Rosa, Maya Dimitrova, Jeffrey S. Weber, Kristen Spencer, Kathleen M Madden, Rafael Winograd.


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