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A Study of Autogene Cevumeran, Atezolizumab, and mFOLFIRINOX for Pancreatic Cancer

This study is looking at people who have had surgery for pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. It compares two treatment approaches: one group receives a combination of autogene cevumeran, atezolizumab, and mFOLFIRINOX, while the other group receives mFOLFIRINOX alone. The goal is to see if adding autogene cevumeran and atezolizumab is more effective and safe in preventing the cancer from returning. To join, you must be at least 18 years old, have a confirmed diagnosis of PDAC that has been completely removed by surgery, and show no signs of disease after the operation. The main way success will be measured is by how long people live without the cancer coming back (Disease Free Survival), for up to about 6 years. The current status of this study is unclear, and it plans to enroll about 260 participants.

Study design
This is an interventional study comparing two different treatment groups. It plans to enroll 260 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 6 years to see if the disease returns or if a new cancer develops.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05968326

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Genentech, Inc.
~260 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:Autogene cevumeranAtezolizumabmFOLFIRINOX

At a glance

Recruiting sites
0 of 87 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease Free Survival (DFS)
Measured over 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

Conditions

Adenocarcinoma, Pancreatic Ductal

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NCT05968326

Where you'd take part

This study runs at 87 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Addenbrookes Hospital

    Cambridge, United Kingdomno site contact published

  • Amsterdam UMC Location VUMC

    Amsterdam, Netherlandsno site contact published

  • Antwerp University Hospital

    Edegem, VAN, Belgiumno site contact published

  • AZ Maria Middelares

    Ghent, Belgiumno site contact published

  • Barts Health NHS Trust

    London, United Kingdomno site contact published

  • Belfast City Hospital

    Belfast, United Kingdomno site contact published

  • Boston Medical Center (BMC) - Cancer Care Center

    Boston, Massachusettsno site contact published

  • Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital

    Montreal, Quebec, Canadano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Disease Free Survival (DFS)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