drugset / Trial / NCT05968326
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.
Timeline
- Start
- 2023-10-18
- Primary completion
- 2031-01-01
- Completion
- 2031-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1680 mg | Intravenous |
| Subject | Autogene cevumeran | Messenger RNA (mRNA) | — | Intravenous |
| Background | Irinotecan | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Oxaliplatin | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |