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Clinical Trials in the UK / NCT05968326
Active, not recruiting Phase 2

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

NCT05968326 · tracked via the Priya Life Science UK tracker
Sponsor
Genentech, Inc.
Phase
Phase 2
Started
2023-10-18
Last updated
2026-09-09

Condition(s) studied

Adenocarcinoma, Pancreatic Ductal

Investigational drug(s) / intervention(s)

Autogene cevumeranAtezolizumabmFOLFIRINOX

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

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion 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 treatment initiation * 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. Exclusion Criteria: * 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).

Primary outcome measure(s)

Trial sites (87)

FacilityCityRegionStatus
USC Norris Comprehensive Cancer Center Los Angeles California
USC Norris Cancer Center Newport Beach California
University of California, San Francisco (UCSF) San Francisco California
University of California Los Angeles Santa Monica California
St. Francis Hospital and Medical Center Hartford Connecticut
Yale Cancer Center New Haven Connecticut
Smilow Cancer Hospital Care Center at Trumbull Trumbull Connecticut
Northwestern Memorial Hospital Chicago Illinois
Indiana University Health Melvin & Bren Simon Cancer Center Indianapolis Indiana
University of Kentucky Medical Center Lexington Kentucky
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center Boston Massachusetts
Boston Medical Center (BMC) - Cancer Care Center Boston Massachusetts
Henry Ford Health System Detroit Michigan
University of Nebraska Omaha Nebraska
Memorial Sloan Kettering Cancer Center Basking Ridge Basking Ridge New Jersey
Memorial Sloan Kettering Cancer Center Middletown New Jersey
Memorial Sloan Kettering Cancer Center at Bergen Montvale New Jersey
Memorial Sloan Kettering Cancer Center - Commack Commack New York
Memorial Sloan Kettering Cancer Center at Westchester Harrison New York
Northwell Health Lake Success New York
Mount SInai Medical Center New York New York
Columbia University Medical Center New York New York
MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH New York New York
Memorial Sloan Kettering Cancer Center New York New York
Memorial Sloan Kettering Cancer Center at Nassau Uniondale New York
Duke Cancer Institute Durham North Carolina
University of Cincinnati Cancer Institute Cincinnati Ohio
Rhode Island Hospital Providence Rhode Island
Miriam Hospital Providence Rhode Island
Fred Hutchinson Cancer Research Center Seattle Washington
Antwerp University Hospital Edegem VAN
ULB Hôpital Erasme Brussels Belgium
AZ Maria Middelares Ghent Belgium
Universitair Ziekenhuis Gent Ghent Belgium
UZ Leuven Leuven Belgium
St Michael Hospital Toronto Ontario
Princess Margaret Cancer Center Toronto Ontario
Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital Montreal Quebec
Jewish General Hospital Montreal Quebec
Centre Hospitalier Régional Universitaire de Lille Lille France

+ 47 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Genentech, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05968326 on ClinicalTrials.gov ↗ ← All trials in the UK