A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

RECRUITING

Condition(s) Being Studied

Adenocarcinoma, Pancreatic Ductal

Study Timeline

Start Date October 18, 2023
Est. Completion January 1, 2031
Last Updated March 1, 2026

Sponsor Information

Genentech, Inc. INDUSTRY

Contact Information

Reference Study ID Number: GO44479 https://forpatients.roche.com/

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Study Overview

Brief 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 Criteria

Gender: ALL
Age Range: 18 Years - N/A

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 ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
  • Adequate hematologic and end-organ function
  • Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 28 days after the final dose of autogene cevumeran, for 9 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab. They must refrain from donating eggs for 9 months after the last dose of chemotherapy.
  • Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period.

Exclusion Criteria:

  • Prior a...

Interventions

DRUG Atezolizumab

Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.

DRUG Autogene cevumeran

Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.

DRUG mFOLFIRINOX

mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

Study Locations (89)

  • USC Norris Comprehensive Cancer Center Los Angeles, California, United States
    RECRUITING
  • USC Norris Cancer Center Newport Beach, California, United States
    RECRUITING
  • University of California, San Francisco (UCSF) San Francisco, California, United States
    RECRUITING
  • University of California Los Angeles Santa Monica, California, United States
    RECRUITING
  • St. Francis Hospital and Medical Center Hartford, Connecticut, United States
    RECRUITING
  • Smilow Cancer Center New Haven, Connecticut, United States
    WITHDRAWN
  • Yale Cancer Center New Haven, Connecticut, United States
    RECRUITING
  • Smilow Cancer Hospital Care Center at Trumbull Trumbull, Connecticut, United States
    RECRUITING
  • Northwestern Memorial Hospital Chicago, Illinois, United States
    RECRUITING
  • Indiana University Health Melvin & Bren Simon Cancer Center Indianapolis, Indiana, United States
    RECRUITING
  • +79 more locations

Interested in This Clinical Trial?

Learn more about this study and see if you may be eligible to participate.

View on ClinicalTrials.gov