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

Merck Sharp & Dohme LLC185 sites in 6 countries1,069 target enrollmentSeptember 24, 2019

ConditionsBiliary Tract Carcinoma

DrugsGemcitabine Cisplatin Placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Biliary Tract Carcinoma
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 1069
Locations: 185
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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 to overall survival (OS).

Registry

clinicaltrials.gov

Start Date

September 24, 2019

End Date

April 1, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
•Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
•Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
•Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
•Has a life expectancy of greater than 3 months
•Has adequate organ function

Exclusion Criteria

•Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
•Has ampullary cancer
•Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
•Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
•Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
•Has had an allogenic tissue/solid organ transplant

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: Up to approximately 38 months

Overall survival was defined as the time from randomization to death due to any cause.

Secondary Outcomes

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)(Up to approximately 26 months)
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)(Up to approximately 26 months)
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR(Up to approximately 38 months)
Number of Participants Who Experience One or More Adverse Events (AE)(Up to approximately 65 months)
Number of Participants Who Discontinued Study Intervention Due to an AE(Up to approximately 63 months)