CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,069 enrolled
Drug / intervention
Pembrolizumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04003636
NCT04003636Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Jul 1, 2019·Updated Mar 24, 2026

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Gemcitabine, and 2 other interventions for Biliary Tract Carcinoma. Completed, enrolled 1,069 participants across 185 sites in 24 countries.

Detailed 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 primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Tract Carcinoma
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 1, 2019
Enrollment StartSep 24, 2019
Primary CompletionDec 15, 2022
Study CompletionApr 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.0 years ago

Interventions

Pembrolizumabbiological

Pembrolizumab by intravenous (IV) infusion

Gemcitabinedrug

Gemcitabine by IV infusion

Cisplatindrug

Cisplatin by IV infusion

Placebodrug

Placebo to pembrolizumab