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Not recruiting
Phase 2

Cevumeran & Atezolizumab

Sponsor:

Genentech, Inc.

Code:

NCT05968326

Conditions

Adenocarcinoma, Pancreatic Ductal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autogene cevumeran

Atezolizumab

mFOLFIRINOX

Study Details

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.

Conditions

Adenocarcinoma, Pancreatic Ductal

Study ID

NCT05968326

Start date

Oct 18, 2023

Status verified date

Sep, 2026

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jan 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 cytochrome P450 3A4 (CYP3A4) and/or uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1).

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX

Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

active comparator: Arm 2: mFOLFIRINOX

Participants will receive mFOLFIRINOX.

Interventions

Autogene cevumeran

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

Atezolizumab

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

mFOLFIRINOX

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

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 and Locations

More Information

Sponsor

Genentech, Inc.

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-09-09.