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
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.
Biliary Tract Cancer
Gemcitabine and Cisplatin
-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
-Has ampullary cancer
-Has received prior anti-cancer therapy for advanced unresectable biliary tract cancer
18 - 100
Healthy Volunteers Needed
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.
Knight Clinical Trials Information Line
Merck Sharp & Dohme Corp