drugset / Trial / NCT06178445
Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer
Phase 2
Active not recruiting
24 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
MSD Sharp & Dohme GmbH, Germany · collabMedizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2024-04-17
- Primary completion
- 2026-12
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |