Clinical Trial

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

Study acronym: TRAP-BTC
Active, Not Recruiting Phase 2
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-12-20; most recent amendment 2026-03-23.
Status change: Recruiting → Active, Not Recruiting 2026-03-23
Status change: Not Yet Recruiting → Recruiting 2024-05-29
Trial Details
NCT Number NCT06178445
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
Conditions Biliary Tract Cancer, HER2 Gene Mutation, HER2
Enrollment 24 participants
Start Date 2024-04-17
Primary Completion 2026-12 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-27