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Study identifier: NCT05968326 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingIMCODE003

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

Condition: Adenocarcinoma, Pancreatic Ductal  ·  Sponsor: Genentech, Inc.

PhasePhase 2
Planned participants260
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where89 locations · 10 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: GO44479 https://forpatients.roche.com/ No attachments to email below.  ·  888-662-6728 (U.S. Only)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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).

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (89)

USC Norris Comprehensive Cancer CenterLos Angeles, California, United StatesRecruiting
USC Norris Cancer CenterNewport Beach, California, United StatesRecruiting
University of California, San Francisco (UCSF)San Francisco, California, United StatesRecruiting
University of California Los AngelesSanta Monica, California, United StatesRecruiting
St. Francis Hospital and Medical CenterHartford, Connecticut, United StatesRecruiting
Smilow Cancer CenterNew Haven, Connecticut, United StatesWithdrawn
Yale Cancer CenterNew Haven, Connecticut, United StatesRecruiting
Smilow Cancer Hospital Care Center at TrumbullTrumbull, Connecticut, United StatesRecruiting
Northwestern Memorial HospitalChicago, Illinois, United StatesRecruiting
Indiana University Health Melvin & Bren Simon Cancer CenterIndianapolis, Indiana, United StatesRecruiting
University of Kentucky Medical CenterLexington, Kentucky, United StatesRecruiting
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer CenterBoston, Massachusetts, United StatesRecruiting

+ 77 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

Los AngelesNewport BeachSan FranciscoSanta Monica

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