RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-10-18
Study Completion:2029-12-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05968326

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed diagnosis of PDAC
  2. * 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
  3. * Macroscopically complete (R0 or R1) resection of PDAC
  4. * Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to randomization
  5. * CA19-9 level measured within 14 days prior to initiation of study treatment
  6. * Interval of between 6 and 12 weeks since resection of PDAC
  7. * Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
  8. * Adequate hematologic and end-organ function
  9. * 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.
  10. * 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.
  1. * Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
  2. * 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
  3. * Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
  4. * Preexisting Grade \>/=2 neuropathy
  5. * Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygous or compound heterozygous mutations of DPYD genetic locus associated with DPD deficiency
  6. * Disorders of the colon or rectum, or postoperative complication leading to Grade \>/=2 diarrhea
  7. * Pregnancy or breastfeeding
  8. * Active or history of autoimmune disease or immune deficiency
  9. * Treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of DPD, within 4 weeks prior to initiation of study treatment
  10. * Current or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and/or uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1).

Contacts and Locations

Study Contact

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

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
USC Norris Cancer Center; USC Oncology Hematology Newport Beach
Newport Beach, California, 92663
United States
University of California, San Francisco (UCSF)
San Francisco, California, 94143
United States
University of California Los Angeles
Santa Monica, California, 90404
United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
United States
Smilow Cancer Center
New Haven, Connecticut, 06510
United States
Yale Cancer Center
New Haven, Connecticut, 06520
United States
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut, 06611
United States
Northwestern Memorial Hospital; Division of Gastroenterology and Hepatology
Chicago, Illinois, 60611
United States
Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536
United States
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
Boston, Massachusetts, 02114-2621
United States
Boston Medical Center (BMC) - Cancer Care Center
Boston, Massachusetts, 02118
United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Cancer Center; MSK Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604
United States
Northwell Health; Monter Cancer Center
Lake Success, New York, 11042
United States
NYU Langone Health
Mineola, New York, 11501
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 11101
United States
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale, New York, 11553
United States
Duke Cancer Institute
Durham, North Carolina, 27710
United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Miriam Hospital
Providence, Rhode Island, 02906
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18
Study Completion Date2029-12-27

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2029-12-27

Terms related to this study

Additional Relevant MeSH Terms

  • Adenocarcinoma, Pancreatic Ductal