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.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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 randomization - 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. - 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 adjuvant, neoadjuvant, or induction treatment for pancreatic cancer - Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and/or chemotherapy), not mandated per protocol, to be initiated after completion of mFOLFIRINOX treatment - Absence of spleen; distal pancreatectomy with splenectomy is exclusionary - Preexisting Grade >/=2 neuropathy - Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygous or compound heterozygous mutations of DPYD genetic locus associated with DPD deficiency - Disorders of the colon or rectum, or postoperative complication leading to Grade >/=2 diarrhea - Pregnancy or breastfeeding - Active or history of autoimmune disease or immune deficiency - Treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of DPD, within 4 weeks prior to initiation of study treatment - Current or planned treatment with strong inhibitors or inducers of CYP3A4 and/or UGT1A1.

Study Design

Phase 2
Study Type
Intervention Model
Parallel Assignment
Primary Purpose
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
  • Drug: Autogene cevumeran
    Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
  • Drug: Atezolizumab
    Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
    Other names:
    • Tecentriq
    mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Active Comparator
Participants will receive mFOLFIRINOX.
    mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

Recruiting Locations

Boston Medical Center (BMC) - Cancer Care Center
Boston, Massachusetts 02118

More Details

Genentech, Inc.

Study Contact

Reference Study ID Number: GO44479 https://forpatients.roche.com/
888-662-6728 (U.S. Only)


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.