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 either Persistent or Recurrent Following BCG Induction or that is Naïve to BCG Treatment (KEYNOTE-676)

High Risk Non-muscle invasive bladder cancer

Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A), Event-Free Survival (EFS) (Cohort B)

EFS (Cohort A), Recurrence-Free Survival (RFS) (Cohorts A and B), Overall Survival (OS) (Cohorts A and B), Disease Specific Survival (DSS) (Cohorts A and B), Time to Cystectomy (Cohorts A and B), 12-Month EFS Rate (Cohort A), Duration of Response (DOR) (Cohorts A and B), 12-Month DOR Rate (Cohorts A and B), Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B), Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B), Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B), Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B), Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B), Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (Cohorts A and B), Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B), TTD in the EQ-5D-5L VAS (Cohorts A and B), CRR by BICR (Cohort B), 24-Month EFS Rate (Cohort B)

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