Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

Official Title

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

Summary:

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect overall survival (OS).

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
  • Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
  • Number of Participants Who Experience One or More Adverse Events (AE)
  • Number of Participants Who Discontinued Study Intervention Due to an Adverse Event
  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

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