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Pembrolizumab in Biliary Tract Cancer

NCT03260712 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-03

No results posted yet for this study

Summary

This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.

Conditions

Interventions

DRUG

Pembrolizumab

The dose of pembrolizumab in this trial is 200 mg Q3W.

DRUG

Cisplatin

25mg/m2 cisplatin on days 1 and 8 of a 21 day cycle

DRUG

Gemcitabine

1000mg/m2 gemcitabine on days 1 and 8 of a 21 day cycle

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Markus Moehler, Prof. Dr. · Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2023-04-27
Completion
2023-08-31

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03260712 on ClinicalTrials.gov