Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

Official Title

A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)

Summary:

A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

Trial Description

Primary Outcome:

• Pathologic Complete Response (pCR) Rate
• Event-Free Survival (EFS)

• Overall Survival (OS)
• Disease-Free Survival (DFS)
• Pathologic Downstaging (pDS) Rate
• Number of Participants Who Experienced an Adverse Event (AE)
• Number of Participants Who Discontinued Study Treatment Due to an AE
• Number of Participants Who Experienced Perioperative Complications
• Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G)
• Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys)
• Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI)
• Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS)
• Time to Deterioration (TTD) in the Total Score of FACT-G
• TTD in EQ-5D-5L VAS

View this trial on ClinicalTrials.gov