CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 158 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/NCT04924062
NCT04924062Phase 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 Jun 11, 2021·Updated Apr 15, 2026

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Gemcitabine, and 2 other interventions for Biliary Tract Carcinoma. Completed, enrolled 158 participants across 22 sites.

Detailed Summary

In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults 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
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 11, 2021
Enrollment StartJul 10, 2020
Primary CompletionDec 15, 2022
Study CompletionMar 25, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.1 years ago

Interventions

Pembrolizumabbiological

Pembrolizumab by intravenous (IV) infusion

Gemcitabinedrug

Gemcitabine by IV infusion

Cisplatindrug

Cisplatin by IV infusion

Placebodrug

Placebo to pembrolizumab by IV infusion