Dysautonomia International

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

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

Adenocarcinoma, Pancreatic Ductal

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

Arm	Description	Assigned 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, California 90033

USC Norris Cancer Center
Newport Beach, California 92663

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

University of California Los Angeles
Santa Monica, California 90404

St. Francis Hospital and Medical Center
Hartford, Connecticut 06105

Yale Cancer Center
New Haven, Connecticut 06520

Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut 06611

Northwestern Memorial Hospital
Chicago, Illinois 60611

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

University of Kentucky Medical Center
Lexington, Kentucky 40536

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

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

Henry Ford Health System
Detroit, Michigan 48202-2610

University of Nebraska
Omaha, Nebraska 68198-5300

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

Memorial Sloan Kettering Cancer Center
Middletown, New Jersey 07748

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

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

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

Northwell Health
Lake Success, New York 11042

Mount SInai Medical Center
New York, New York 10029

Columbia University Medical Center
New York, New York 10032

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

Memorial Sloan Kettering Cancer Center
New York, New York 10065

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

Duke Cancer Institute
Durham, North Carolina 27710-4000

University of Cincinnati Cancer Institute
Cincinnati, Ohio 45219

Rhode Island Hospital
Providence, Rhode Island 02903

Miriam Hospital
Providence, Rhode Island 02906

Fred Hutchinson Cancer Research Center
Seattle, Washington 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.