drugset / Trial / NCT03941093
Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.
Timeline
- Start
- 2019-05-10
- Primary completion
- 2024-06-11
- Completion
- 2024-06-11
Outcome
Missed primary endpoint
registry p = 0.5487; Hazard Ratio (HR) 1.08 (95% CI 0.83 to 1.41); Stratified Log Rank Test NCT03941093 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pamrevlumab | Monoclonal antibody | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Comparator | Irinotecan | Small molecule | — | Intravenous |
| Comparator | Leucovorin | Small molecule | — | Intravenous |
| Comparator | Nab-paclitaxel | Small molecule | — | Intravenous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Comparator | fluorouracil | Small molecule | — | Intravenous |