Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Official Title

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

Summary:

This study is designed to assess the antitumour efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is persistent or recurrent following adequate BCG induction. The primary hypothesis is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS).

Trial Description

Primary Outcome:

  • Complete Response Rate (CRR) by Blinded Independent Central Review (BICR)
Secondary Outcome:
  • Event-Free Survival (EFS)
  • Recurrence-Free Survival (RFS)
  • Overall Survival (OS)
  • Disease Specific Survival (DSS)
  • Time to Cystectomy
  • 12-Month EFS Rate
  • Duration of Response (DOR)
  • 12-Month DOR Rate
  • Time to True Deterioration (TTD) in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30)
  • Percentage of Participants Experiencing Adverse Events (AEs)
  • Percentage of Participants Discontinuing Study Drug Due to AEs
  • Change From Baseline in EORTC-QLQ-C30 Global Health Status (Item 29) Scale Score
  • Change from Baseline in EORTC-QLQ-C30 Quality of Life (Item 30) Scale Score
  • Change from Baseline in EORTC-QLQ-C30 Score
  • Change from Baseline in EORTC QLQ-Non-Muscle Invasive Bladder Cancer Module 24 (NMIBC24) Score
  • Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Index Score
  • Change from Baseline in EuroQoL Visual Analogue Score (EQ VAS)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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