Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)

Official Title

A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)


This is a single-arm, open-label, multicentre, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR)
Secondary Outcome:
  • Duration of Response (DOR)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Percentage of Participants with One or More Adverse events (AEs)
  • Study Intervention Discontinuation due to AEs

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society