A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Genentech, Inc.
- Study ID
- NCT05968326
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Adenocarcinoma, Pancreatic Ductal
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Autogene cevumeran — DRUGAutogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
- Atezolizumab — DRUGAtezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
- mFOLFIRINOX — DRUGmFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Study Details
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.
Key Dates
- Start date
- Oct 18, 2023
- Status verified
- Jun 2026
- Primary completion
- Jan 1, 2031
- Completion
- Jan 1, 2031
Study Design
- Enrollment
- 260 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOXParticipants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
- Active Comparator: Arm 2: mFOLFIRINOXParticipants will receive mFOLFIRINOX.
Primary Outcome Measure
Disease Free Survival (DFS) [ Time Frame: From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years ]
Central Contacts
- Reference Study ID Number: GO44479 https://forpatients.roche.com/888-662-6728 (U.S. Only)
- Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Locations (32)
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By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Cancer Center· Newport Beach, CAUniversity of California, San Francisco (UCSF)· San Francisco, CAUniversity of California Los Angeles· Santa Monica, CASt. Francis Hospital and Medical Center· Hartford, CTSmilow Cancer Center· New Haven, CT