Study on the Effectiveness and Safety of Adding Autogene Cevumeran and Atezolizumab to mFOLFIRINOX in Patients with Removed Pancreatic Cancer

Sponsor: Genentech, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05968326

Provider View

This study compares the effectiveness and safety of a new treatment combination with the standard treatment for patients who have had surgery to remove pancreatic cancer and have no signs of the disease.

Patient Parameters

Program Overview

This study is looking at how well a new combination of treatments works for people who have had surgery to remove pancreatic cancer. The new treatment includes autogene cevumeran and atezolizumab, along with a chemotherapy regimen called mFOLFIRINOX. The study will compare this new combination to the standard mFOLFIRINOX treatment alone. Participants must not have received any previous cancer treatment for their pancreatic cancer and should show no signs of the disease after surgery.

Description

The study aims to find out if adding autogene cevumeran and atezolizumab to the standard chemotherapy treatment, mFOLFIRINOX, is more effective and safe for patients who have had their pancreatic cancer surgically removed. Participants in this study will be randomly assigned to receive either the new combination treatment or the standard mFOLFIRINOX treatment alone. The study will monitor the participants' health and any side effects they experience to determine the safety and effectiveness of the new treatment combination. This research is important because it could lead to better treatment options for people with pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  • Cancer staging of T1-T3, N0-N2, and M0 according to the AJCC Cancer Staging Manual
  • Complete surgical removal of the cancer (R0 or R1 resection)
  • No signs of cancer after surgery, as confirmed by the doctor within 28 days before starting the study
  • CA19-9 level checked within 14 days before starting the study treatment
  • Surgery was done between 6 and 12 weeks ago
  • Fully recovered from surgery and able to receive the study treatments, as judged by the doctor
  • Good blood and organ function
  • Women who can have children must agree to avoid pregnancy during treatment and for a specified time after the last dose of each study drug
  • Men with partners who can have children must agree to use birth control or remain abstinent during treatment and for a specified time after the last dose of each study drug, and must not donate sperm during this time.

Exclusion Criteria

  • Previous treatment for pancreatic cancer before joining the study
  • Plans for additional cancer treatment after mFOLFIRINOX that is not part of the study
  • Removal of the spleen during surgery
  • Existing moderate to severe nerve damage
  • Known deficiency in the enzyme DPD, which affects drug metabolism
  • Digestive issues or complications after surgery leading to moderate to severe diarrhea
  • Currently pregnant or breastfeeding
  • History of autoimmune disease or immune deficiency
  • Recent treatment with certain drugs that affect DPD enzyme activity
  • Current or planned use of strong drugs that affect liver enzymes CYP3A4 and UGT1A1.

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