drugset / Trial / NCT04753879
Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
Phase 2
Active not recruiting
38 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and clinical activity of maintenance olaparib and pembrolizumab following multi-agent, low dose chemotherapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with untreated metastatic pancreatic ductal cancer.
Timeline
- Start
- 2021-09-29
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 500 mg | Oral |
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |