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

Description

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.

Conditions

Adenocarcinoma, Pancreatic Ductal

Study Overview

Study Details

Study overview

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.

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

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

Condition
Adenocarcinoma, Pancreatic Ductal
Intervention / Treatment

-

Contacts and Locations

Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Newport Beach

USC Norris Cancer Center; USC Oncology Hematology Newport Beach, Newport Beach, California, United States, 92663

San Francisco

University of California, San Francisco (UCSF), San Francisco, California, United States, 94143

Santa Monica

University of California Los Angeles, Santa Monica, California, United States, 90404

Hartford

St. Francis Hospital and Medical Center, Hartford, Connecticut, United States, 06105

New Haven

Smilow Cancer Center, New Haven, Connecticut, United States, 06510

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06520

Trumbull

Smilow Cancer Hospital Care Center at Trumbull, Trumbull, Connecticut, United States, 06611

Chicago

Northwestern Memorial Hospital; Division of Gastroenterology and Hepatology, Chicago, Illinois, United States, 60611

Indianapolis

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 randomization
  • * 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.
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2029-12-27