Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/KEYNOTE-054)

Official Title

Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK- 3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group

Summary:

This study will assess whether post-resection adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA [> 1 mm metastasis], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death ligand 1 (PD-L1)-positive tumour expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo.

Trial Description

Primary Outcome:

• Recurrence-free survival (RFS) for All Participants
• RFS for Participants with PD-L1-positive Tumour Expression

• Distant Metastases-free Survival (DMFS) in All Participants
• DMFS for Participants with PD-L1-positive Tumour Expression
• Overall Survival (OS) in All Participants
• OS in for Participants with PD-L1-positive Tumour Expression

View this trial on ClinicalTrials.gov