A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma
Genentech, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed diagnosis of PDAC * Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual * Macroscopically complete (R0 or R1) resection of PDAC * Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to treatment initiation * CA19-9 level measured within 14 days prior to initiation of study treatment * Interval of between 6 and 12 weeks since resection of PDAC * Full recovery from surgery and ab…
Interventions
- DrugAutogene cevumeran
Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
- DrugAtezolizumab
Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
- DrugmFOLFIRINOX
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Locations (89)
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- USC Norris Cancer CenterNewport Beach, California
- University of California, San Francisco (UCSF)San Francisco, California
- University of California Los AngelesSanta Monica, California
- St. Francis Hospital and Medical CenterHartford, Connecticut
- Smilow Cancer CenterNew Haven, Connecticut