RecruitingPhase 2NCT05968326

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

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

Sponsor

Genentech, Inc.

Enrollment

260 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Adenocarcinoma, Pancreatic Ductal

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine called autogene cevumeran, combined with an immunotherapy drug (atezolizumab) and standard chemotherapy, in people who have had surgery to remove pancreatic cancer. The goal is to see whether this combination reduces the chance of the cancer coming back after surgery. Pancreatic cancer (PDAC) has a high recurrence rate, and researchers hope this immunotherapy approach can help the immune system target any remaining cancer cells. **You may be eligible if...** - You have had surgery to completely remove pancreatic cancer (PDAC) 6 to 12 weeks ago - Your cancer was confirmed by a biopsy and was stage T1–T3, N0–N2, M0 (meaning it hadn't spread beyond nearby lymph nodes) - You have recovered well from surgery and have no signs of remaining disease - Your blood counts, liver, and kidney function are in acceptable ranges - You are willing to use contraception during and after treatment **You may NOT be eligible if...** - You have had prior chemotherapy or radiation for this cancer before surgery - You have signs of cancer remaining after surgery - You are pregnant or breastfeeding - You have certain autoimmune conditions or are on immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAutogene cevumeran

Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.

DRUGAtezolizumab

Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.

DRUGmFOLFIRINOX

mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

Locations(89)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Cancer Center

Newport Beach, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

University of California Los Angeles

Santa Monica, California, United States

St. Francis Hospital and Medical Center

Hartford, Connecticut, United States

Smilow Cancer Center

New Haven, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Trumbull

Trumbull, Connecticut, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Indiana University Health Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center

Boston, Massachusetts, United States

Boston Medical Center (BMC) - Cancer Care Center

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Nebraska

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center

Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center at Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States

Northwell Health

Lake Success, New York, United States

NYU Langone Health