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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

Cancer Type
Trial Phase
Phase III
18 Years and older, Male and Female
Study Type
Protocol IDs
3475-966 (primary)
Study Sponsor
Merck and Company Inc


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 study has 2 primary hypotheses: 1. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) and 2. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to overall survival (OS).

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Marietta

340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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