> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-the-efficacy-and-safety-of-adjuvant-autogene-0fd31dc5-b562-4742-9912-7802b13d3e70 > Record changed: 2026-11-04 # A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC NCT05968326 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) Participants 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) Lead sponsor Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) Start date 2023-10-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) Number of sites 87 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Acronym** IMCODE003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Short title** A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Dates **Completion date** 2031-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **First posted** 2023-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Registry last updated** 2026-09-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Primary completion date** 2031-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Start date** 2023-10-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Size and sites **Participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Planned participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Number of sites** 87 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Lead sponsor** Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Identifiers **Registry ID** NCT05968326 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **ClinicalTrials.gov ID** NCT05968326 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Outcomes ### Primary outcomes 1. Disease Free Survival (DFS) Timeframe: 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 ### Secondary outcomes 1. DFS Rates at 12, 24, and 36 Months Timeframe: Months 12, 24, 36 2. Overall Survival (OS) Timeframe: From randomization to death from any cause (up to approximately 6 years) 3. OS Rates at 3 and 5 Years Timeframe: Years 3 and 5 4. Percentage of Participants With Adverse Events (AEs) Timeframe: Up to approximately 6 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Sites - USC Norris Comprehensive Cancer CenterLos Angeles, United States - USC Norris Cancer CenterNewport Beach, United States - University of California, San Francisco (UCSF)San Francisco, United States - University of California Los AngelesSanta Monica, United States - St. Francis Hospital and Medical CenterHartford, United States - Yale Cancer CenterNew Haven, United States - Smilow Cancer Hospital Care Center at TrumbullTrumbull, United States - Northwestern Memorial HospitalChicago, United States - Indiana University Health Melvin & Bren Simon Cancer CenterIndianapolis, United States - University of Kentucky Medical CenterLexington, United States - Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer CenterBoston, United States - Boston Medical Center (BMC) - Cancer Care CenterBoston, United States - Henry Ford Health SystemDetroit, United States - University of NebraskaOmaha, United States - Memorial Sloan Kettering Cancer Center Basking RidgeBasking Ridge, United States - Memorial Sloan Kettering Cancer CenterMiddletown, United States - Memorial Sloan Kettering Cancer Center at BergenMontvale, United States - Memorial Sloan Kettering Cancer Center - CommackCommack, United States - Memorial Sloan Kettering Cancer Center at WestchesterHarrison, United States - Northwell HealthLake Success, United States - Mount SInai Medical CenterNew York, United States - Columbia University Medical CenterNew York, United States - MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHHNew York, United States - Memorial Sloan Kettering Cancer CenterNew York, United States - Memorial Sloan Kettering Cancer Center at NassauUniondale, United States And 62 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers - 2022-502404-73-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968326) ## Related records ### Drugs (6) - [Atezolizumab](https://trialight.com/data/asset/atezolizumab-2cce6944-73b7-49f4-8125-4e6747997b82.md) - [Autogene cevumeran](https://trialight.com/data/asset/autogene-cevumeran-eb4276fe-4301-43ae-889f-3f338e7e2485.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Leucovorin calcium](https://trialight.com/data/asset/leucovorin-calcium-8da292ca-1b92-4365-b525-77d897b1c096.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) ### Collaborators (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Lead sponsors (1) - [Genentech, Inc.](https://trialight.com/data/company/genentech-inc-36ac9a9c-11fd-490c-a8c8-30c070bd99d2.md) ### Conditions (2) - [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) Primary condition ### Targets (3) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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