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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX 		Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
  • 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.
    Other names:
    • Tecentriq
  • Drug: mFOLFIRINOX
    mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Active Comparator
Arm 2: mFOLFIRINOX 		Participants will receive mFOLFIRINOX.
  • Drug: mFOLFIRINOX
    mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

Recruiting Locations

USC Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033

USC Norris Cancer Center
Newport Beach 5376890, California 5332921 92663

University of California, San Francisco (UCSF)
San Francisco 5391959, California 5332921 94158-2350

University of California Los Angeles
Santa Monica 5393212, California 5332921 90404

St. Francis Hospital and Medical Center
Hartford 4835797, Connecticut 4831725 06105

Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06520

Smilow Cancer Hospital Care Center at Trumbull
Trumbull 4844459, Connecticut 4831725 06611

Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis 4259418, Indiana 4921868 46202

University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536

Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
Boston 4930956, Massachusetts 6254926 02114-2621

Boston Medical Center (BMC) - Cancer Care Center
Boston 4930956, Massachusetts 6254926 02118

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202-2610

University of Nebraska
Omaha 5074472, Nebraska 5073708 68198-5300

Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge 5095409, New Jersey 5101760 07920

Memorial Sloan Kettering Cancer Center
Middletown 5101170, New Jersey 5101760 07748

Memorial Sloan Kettering Cancer Center at Bergen
Montvale 5101361, New Jersey 5101760 07645

Memorial Sloan Kettering Cancer Center - Commack
Commack 5113412, New York 5128638 11725

Memorial Sloan Kettering Cancer Center at Westchester
Harrison 5120095, New York 5128638 10604

Northwell Health
Lake Success 5123853, New York 5128638 11042

NYU Langone Health
New York 5128581, New York 5128638 10016

Mount SInai Medical Center
New York 5128581, New York 5128638 10029

Columbia University Medical Center
New York 5128581, New York 5128638 10032

MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH
New York 5128581, New York 5128638 10065-7471

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065

Memorial Sloan Kettering Cancer Center at Nassau
Uniondale 5141927, New York 5128638 11553

Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27710-4000

University of Cincinnati Cancer Institute
Cincinnati 4508722, Ohio 5165418 45219

Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903

Miriam Hospital
Providence 5224151, Rhode Island 5224323 02906

Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GO44479 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.