A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
Summary
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. Primary Objectives * To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm. Secondary Objectives * To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC. * To determine progression-free survival (PFS) for each investigational arm vs. SOC. * To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first). * To determine rates of clinical benefit; duration of clinical benefit.
Timeline
- Start
- 2020-01-31
- Primary completion
- 2025-02-05
- Completion
- 2025-02-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Canakinumab | Monoclonal antibody | 250 mg | Subcutaneous |
| Subject | Pamrevlumab | Monoclonal antibody | 35 mg/kg | Intravenous |
| Subject | SM-88 | Unknown | 460 mg | Oral |
| Subject | Spartalizumab | Monoclonal antibody | 400 mg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 150 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |