IRB #

STUDY00020506

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

Principal Investigator

Charles Lopez

Study Purpose

The purpose of this study is to test the safety and how well the study drug, pembrolizumab, works in combination with chemotherapy drugs gemcitabine and cisplatin.

Medical Condition(s)

Cholangiocarcinoma
Biliary Tract Cancer
Gemcitabine and Cisplatin
Gallbladder cancer

Eligibility Criteria

Inclusion
-Has histologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
-At least 18 years old

Exclusion
-Has ampullary cancer
-Has received prior anti-cancer therapy for advanced unresectable biliary tract cancer

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will be on the study drug or placebo for up to about 2 years, as long as you do not have serious side effects that require you to stop taking it and your cancer is not getting worse and when you stop taking the study drug, you will be asked to come to the clinic for follow-up imaging until you start new treatment for your cancer or if your cancer gets worse.

If eligible, you may receive study drug or placebo for an additional year before entering the follow-up period.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Merck Sharp & Dohme Corp

Recruitment End

11/03/2025

Compensation Provided

No


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