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

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

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.

N/A

Adenocarcinoma, Pancreatic Ductal

DRUG: Autogene cevumeran
DRUG: Atezolizumab
DRUG: mFOLFIRINOX

GO44479
2022-502404-73-00 (REGISTRY Identifier) (REGISTRY: EU CT Number)

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	Results Reporting Dates	Study Record Updates
First Submitted 2023-07-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-03
First Submitted that Met QC Criteria 2023-07-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-25
First Posted (ACTUAL) 2023-08-01	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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. 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.

Participant Group/Arm

Intervention/Treatment

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.

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.

Primary Outcome Measures	Measure Description	Time Frame
Disease Free Survival (DFS)		From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years

Secondary Outcome Measures	Measure Description	Time Frame
DFS Rates at 12, 24, and 36 Months		Months 12, 24, 36
Overall Survival (OS)		From randomization to death from any cause (up to approximately 6 years)
OS Rates at 3 and 5 Years		Years 3 and 5
Percentage of Participants With Adverse Events (AEs)		Up to approximately 6 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Reference Study ID Number: GO44479 https://forpatients.roche.com/

Phone Number: 888-662-6728 (U.S. Only)

Email: global-roche-genentech-trials@gene.com

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

BioNTech SE

Investigators

STUDY_DIRECTOR: Clinical Trials, Hoffmann-La Roche

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

Patients

Caregivers

Clinical Trial Record