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 in All Participants
  • Pathologic Complete Response Rate in Participants Whose Tumours Express PD-L1 Combined Positive Score (CPS) ≥10
  • Event-Free Survival (EFS) in All Participants
  • Event-Free Survival in Participants Whose Tumours Express PD-L1, CPS ≥10
Secondary Outcome:
  • Overall Survival (OS) in All Participants
  • Overall Survival in Participants Whose Tumours Express PD-L1, CPS ≥10
  • Disease-Free Survival (DFS) in All Participants
  • Disease-Free Survival in Participants Whose Tumours Express PD-L1, CPS ≥10
  • Pathologic Downstaging (pDS) Rate in All Participants
  • Pathologic Downstaging (pDS) Rate in Participants Whose Tumours Express PD-L1, CPS ≥10
  • Number of Participants Experiencing Adverse Events (AEs)
  • Number of Participants Discontinuing Study Drug Due to an AE
  • Number of Participants Experiencing 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 Functional Assessment of Cancer Therapy-Bladder Cancer-Specific Subscale/Symptom Index for Participants Undergoing Cystectomy (Total Score FACT BI-Cys)
  • Change in Patient-Reported Outcomes from Baseline in FACT-Bl-Cys-Trial Outcome Index (TOI)
  • Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS)
  • Change in Patient-Reported Outcomes from Baseline in EQ-5D-5L Utility Score
  • Time to Deterioration (TTD) in the Total Score of FACT-G
  • Time to Deterioration in EQ-5D-5L VAS

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society