drugset / Trial / NCT05268510
Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib As Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma
Phase 2
Completed
31 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity of a first-line therapy consisting of induction chemotherapy plus pembrolizumab (12 weeks of mod. FOLFOX-6 plus pembrolizumab or 12 weeks of CAPOX plus pembrolizumab) followed by pembrolizumab plus olaparib.
Timeline
- Start
- 2022-09-15
- Primary completion
- 2024-08-27
- Completion
- 2025-01-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Olaparib | Small molecule | 300 mg | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |