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RECRUITING

NCT05968326

PHASE2

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

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2023-10-18

Completion Date

2031-01-01

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Adenocarcinoma, Pancreatic Ductal

Interventions

DRUG

Autogene cevumeran

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

DRUG

Atezolizumab

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

DRUG

mFOLFIRINOX

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

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).

Locations (89)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Cancer Center

Newport Beach, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

University of California Los Angeles

Santa Monica, California, United States

St. Francis Hospital and Medical Center

Hartford, Connecticut, United States

Smilow Cancer Center

New Haven, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Trumbull

Trumbull, Connecticut, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Indiana University Health Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

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

Boston, Massachusetts, United States

Boston Medical Center (BMC) - Cancer Care Center

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Nebraska

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center

Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center at Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States

Northwell Health

Lake Success, New York, United States

NYU Langone Health