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RecruitingInterventionalPhase 2

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

NCT ID: NCT05968326Sponsor: Genentech, Inc.Last updated: 2026-06-09

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.

Arms & interventions

  • DrugAutogene cevumeran

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

  • DrugAtezolizumab

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

  • DrugmFOLFIRINOX

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

Outcome measures

Primary

  • 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

Secondary

  • DFS Rates at 12, 24, and 36 Months

    Time frame: Months 12, 24, 36

  • Overall Survival (OS)

    Time frame: From randomization to death from any cause (up to approximately 6 years)

  • OS Rates at 3 and 5 Years

    Time frame: Years 3 and 5

  • Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 6 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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).

Study locations (32)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

USC Norris Cancer Center

Newport Beach, California, 92663

Recruiting

University of California, San Francisco (UCSF)

San Francisco, California, 94158-2350

Recruiting

University of California Los Angeles

Santa Monica, California, 90404

Recruiting

St. Francis Hospital and Medical Center

Hartford, Connecticut, 06105

Recruiting

Smilow Cancer Center

New Haven, Connecticut, 06510

Withdrawn

Yale Cancer Center

New Haven, Connecticut, 06520

Recruiting

Smilow Cancer Hospital Care Center at Trumbull

Trumbull, Connecticut, 06611

Recruiting

Northwestern Memorial Hospital

Chicago, Illinois, 60611

Recruiting

Indiana University Health Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202

Recruiting

University of Kentucky Medical Center

Lexington, Kentucky, 40536

Recruiting

Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center

Boston, Massachusetts, 02114-2621

Recruiting

Boston Medical Center (BMC) - Cancer Care Center

Boston, Massachusetts, 02118

Recruiting

Henry Ford Health System

Detroit, Michigan, 48202-2610

Recruiting

University of Nebraska

Omaha, Nebraska, 68198-5300

Recruiting

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, 07920

Recruiting

Memorial Sloan Kettering Cancer Center

Middletown, New Jersey, 07748

Recruiting

Memorial Sloan Kettering Cancer Center at Bergen

Montvale, New Jersey, 07645

Recruiting

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, 11725

Recruiting

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, 10604

Recruiting

Northwell Health

Lake Success, New York, 11042

Recruiting

NYU Langone Health

New York, New York, 10016

Active Not Recruiting

Mount SInai Medical Center

New York, New York, 10029

Recruiting

Columbia University Medical Center

New York, New York, 10032

Recruiting

MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH

New York, New York, 10065-7471

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Memorial Sloan Kettering Cancer Center at Nassau

Uniondale, New York, 11553

Recruiting

Duke Cancer Institute

Durham, North Carolina, 27710-4000

Recruiting

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45219

Recruiting

Rhode Island Hospital

Providence, Rhode Island, 02903

Recruiting

Miriam Hospital

Providence, Rhode Island, 02906

Recruiting

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

Recruiting