Overview

Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer

Status:
Recruiting

Trial end date:
2028-04-01

Target enrollment:

Participant gender:

Summary

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy (gemcitabine/cisplatin) + trastuzumab + pembrolizumab as first-line treatment for cholangiocarcinoma and gallbladder cancer patients. Patients suffering from previously untreated HER2 (human epidermal growth factor receptor 2) positive, unresectable cholangiocarcinoma and gallbladder cancer will be included in the study and are scheduled to receive triplet regimen consisting of a combination of pembrolizumab, trastuzumab and gemcitabine/cisplatin (GemCis).

Phase:

Phase 2

Details

Lead Sponsor:

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborators:

Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel
MSD Sharp & Dohme GmbH, Germany

Treatments:

Pembrolizumab
Trastuzumab