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

Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
USC Norris Cancer Center
RECRUITING
Newport Beach
University of California, San Francisco (UCSF)
RECRUITING
San Francisco
Connecticut
St. Francis Hospital and Medical Center
RECRUITING
Hartford
Smilow Cancer Center
WITHDRAWN
New Haven
Yale Cancer Center
RECRUITING
New Haven
Smilow Cancer Hospital Care Center at Trumbull
RECRUITING
Trumbull
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Indiana
Indiana University Health Melvin & Bren Simon Cancer Center
RECRUITING
Indianapolis
Kentucky
University of Kentucky Medical Center
RECRUITING
Lexington
Massachusetts
Boston Medical Center (BMC) - Cancer Care Center
RECRUITING
Boston
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
North Carolina
Duke Cancer Institute
RECRUITING
Durham
Nebraska
University of Nebraska
RECRUITING
Omaha
New Jersey
Memorial Sloan Kettering Cancer Center Basking Ridge
RECRUITING
Basking Ridge
Memorial Sloan Kettering Cancer Center
RECRUITING
Middletown
Memorial Sloan Kettering Cancer Center at Bergen
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center - Commack
RECRUITING
Commack
Memorial Sloan Kettering Cancer Center at Westchester
RECRUITING
Harrison
Northwell Health
RECRUITING
Lake Success
Columbia University Medical Center
RECRUITING
New York
MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Mount SInai Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Memorial Sloan Kettering Cancer Center at Nassau
RECRUITING
Uniondale
Ohio
University of Cincinnati Cancer Institute
RECRUITING
Cincinnati
Rhode Island
Miriam Hospital
RECRUITING
Providence
Rhode Island Hospital
RECRUITING
Providence
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Other Locations
Belgium
ULB Hôpital Erasme
RECRUITING
Brussels
Antwerp University Hospital
RECRUITING
Edegem
AZ Maria Middelares
RECRUITING
Ghent
Universitair Ziekenhuis Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Canada
Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
Princess Margaret Cancer Center
RECRUITING
Toronto
St Michael Hospital
RECRUITING
Toronto
France
Centre Hospitalier Régional Universitaire de Lille
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
Institut Paoli Calmettes
RECRUITING
Marseille
Institut de Cancérologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Germany
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
RECRUITING
Berlin
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)
RECRUITING
Bochum
Universitaetsklinikum Koeln
RECRUITING
Cologne
Universitätsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitätsklinikum Essen
RECRUITING
Essen
Krankenhaus Nordwest GmbH
RECRUITING
Frankfurt
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg
RECRUITING
Heidelberg
Klinikum Bogenhausen
RECRUITING
München
Universitaetsklinikum Tuebingen
RECRUITING
Tübingen
Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale
RECRUITING
Ulm
Uniklinikum Würzburg, Med. Klinik und Poliklinik II
RECRUITING
Würzburg
Netherlands
Amsterdam UMC Location VUMC
RECRUITING
Amsterdam
UMC Radboud Nijmegen
RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
Republic of Korea
National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer
RECRUITING
Goyang-si
CHA Bundang Medical Center
RECRUITING
Gyeonggi-do
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
RECRUITING
Seocho
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital - Yonsei Cancer Center
RECRUITING
Seoul
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
RECRUITING
Songpa-gu
Spain
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitario Vall d Hebron
RECRUITING
Barcelona
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
RECRUITING
Madrid
Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Clinica Universitaria de Navarra (CUN)
RECRUITING
Pamplona/iruña
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Karolinska Universitetssjukhuset
RECRUITING
Solna
United Kingdom
Belfast City Hospital
RECRUITING
Belfast
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Addenbrookes Hospital
RECRUITING
Cambridge
Royal Liverpool University Hospital
RECRUITING
Liverpool
Barts Health NHS Trust
RECRUITING
London
Guys Hospital
RECRUITING
London
Hammersmith Hospital
RECRUITING
London
University College London Cancer Institute
RECRUITING
London
Contact Information
Primary
Reference Study ID Number: GO44479 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2023-10-18
Estimated Completion Date: 2031-01-01
Participants
Target number of participants: 260
Treatments
Experimental: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
Active_comparator: Arm 2: mFOLFIRINOX
Participants will receive mFOLFIRINOX.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.
Collaborators: BioNTech SE

This content was sourced from clinicaltrials.gov