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Evaluating a new treatment combination for resected pancreatic cancer

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

PHASE2 · Genentech, Inc. · NCT05968326

This study is testing a new combination treatment for people who have had surgery for pancreatic cancer to see if it works better than the standard treatment alone.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment260 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. (industry)
Drugs / interventionsatezolizumab, chemotherapy
Locations89 sites (Los Angeles, California and 88 other locations)
Trial IDNCT05968326 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of a combination treatment involving autogene cevumeran, atezolizumab, and mFOLFIRINOX compared to mFOLFIRINOX alone in patients with resected pancreatic ductal adenocarcinoma (PDAC). Participants must have undergone surgery and show no evidence of disease post-operation. The study will involve monitoring the patients' response to the treatment and any associated side effects. It is designed for individuals who have not received prior systemic anti-cancer treatment for PDAC.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed resected PDAC who have no evidence of disease after surgery.

Not a fit: Patients with metastatic disease or those who have received prior systemic anti-cancer treatment for PDAC will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with resected PDAC by enhancing disease-free survival rates.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy and chemotherapy combinations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Los Angeles, California and 88 other locations

+39 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Adenocarcinoma, Pancreatic Ductal

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.