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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

Status
Active
Cancer Type
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04003636
Protocol IDs
3475-966 (primary)
NCI-2019-05779
2019-000944-82
MK-3475-966
KEYNOTE-966
Study Sponsor
Merck and Company Inc

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 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
770-281-5131
www.ngoc.com

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**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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