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

Recruiting now · Phase 2

Conditions studied: Adenocarcinoma, Pancreatic Ductal

In brief

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.

Key facts

Study ID

NCT05968326

Run by

Genentech, Inc.

People needed

260

Starts

2023-10-18

Expected to finish

2031-01-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• University of California Los Angeles — Santa Monica, California, United States (enrolling)
• USC Norris Cancer Center — Newport Beach, California, United States (enrolling)
• University of California, San Francisco (UCSF) — San Francisco, California, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center at Trumbull — Trumbull, Connecticut, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• Indiana University Health Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• St. Francis Hospital and Medical Center — Hartford, Connecticut, United States (enrolling)
• Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center — Boston, Massachusetts, United States (enrolling)
• Boston Medical Center (BMC) - Cancer Care Center — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• University of Nebraska — Omaha, Nebraska, United States (enrolling)
• Memorial Sloan Kettering Cancer Center Basking Ridge — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center at Bergen — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center - Commack — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center at Westchester — Harrison, New York, United States (enrolling)
• Northwell Health — Lake Success, New York, United States (enrolling)
• University of Kentucky Medical Center — Lexington, Kentucky, United States (enrolling)
• Mount SInai Medical Center — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center at Nassau — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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