Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-small Cell Lung Cancer (MK-3475-598/KEYNOTE-598)

Official Title

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumours Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)


The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
  • Progression-free Survival (PFS)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration Of Response (DOR)
  • Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath
  • Incidence of Adverse Events (AEs)
  • Incidence of Discontinuations

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society