NCT06178445

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Biliary Tract Cancer
• HER2 Gene Mutation
• HER2

Interventions

Type	Name	Description
DRUG	SOC plus trastuzumab and pembrolizumab	SOC treatment with gemcitabine/cisplatin in combination with trastuzumab and pembrolizumab

Timeline

• Start date: 2024-04-17
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2023-12-21
• Last updated: 2026-03-27

Locations

8 sites across 1 country: Germany