Clinical Trial

Biliary Tract Carcinoma Treatment

Study Description

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

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).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Pembrolizumab

Pembrolizumab by intravenous (IV) infusion

Drug - Gemcitabine

Gemcitabine by IV infusion

Drug - Cisplatin

Cisplatin by IV infusion

Drug - Placebo

Placebo to pembrolizumab

Additional Information

Official Study 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

Clinical Trial ID

NCT04003636

ParticipAid ID

dPNq4a