Actively Recruiting
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
Led by Genentech, Inc. · Updated on 2026-05-11
260
Participants Needed
89
Research Sites
376 weeks
Total Duration
On this page
Sponsors
G
Genentech, Inc.
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)
- Tumor staging of T1-T3, N0-N2, and M0 according to AJCC guidelines
- Complete surgical removal of PDAC with no visible disease after surgery
- CA19-9 tumor marker measured within 14 days before treatment start
- Surgery performed 6 to 12 weeks before starting study treatment
- Full recovery from surgery and ability to receive study treatments as judged by the investigator
- Adequate blood and organ function
- Female participants of childbearing potential agree to use contraception during treatment and specified periods after
- Male participants with partners of childbearing potential agree to use contraception or abstain during treatment and specified periods after
You will not qualify if you...
- Prior chemotherapy, radiation, or other systemic treatment for pancreatic cancer
- Planned additional anti-cancer therapy after mFOLFIRINOX not required by the study
- Absence of spleen or distal pancreatectomy with splenectomy
- Moderate or worse neuropathy (Grade 2 or higher)
- Known complete deficiency of dihydropyrimidine dehydrogenase (DPD)
- Colon or rectal disorders or postoperative complications causing moderate or worse diarrhea
- Pregnancy or breastfeeding
- Active or past autoimmune disease or immune deficiency
- Use of certain antiviral drugs (brivudine, sorivudine) within 4 weeks before treatment
- Current or planned use of strong drugs affecting cytochrome P450 3A4 or UGT1A1 enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 89 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
USC Norris Cancer Center
Newport Beach, California, United States, 92663
Actively Recruiting
3
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94158-2350
Actively Recruiting
4
University of California Los Angeles
Santa Monica, California, United States, 90404
Actively Recruiting
5
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Actively Recruiting
6
Smilow Cancer Center
New Haven, Connecticut, United States, 06510
Withdrawn
7
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
8
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
9
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
11
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
12
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
Boston, Massachusetts, United States, 02114-2621
Actively Recruiting
13
Boston Medical Center (BMC) - Cancer Care Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
14
Henry Ford Health System
Detroit, Michigan, United States, 48202-2610
Actively Recruiting
15
University of Nebraska
Omaha, Nebraska, United States, 68198-5300
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
17
Memorial Sloan Kettering Cancer Center
Middletown, New Jersey, United States, 07748
Actively Recruiting
18
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
19
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, United States, 11725
Actively Recruiting
20
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, United States, 10604
Actively Recruiting
21
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
22
NYU Langone Health
New York, New York, United States, 10016
Active, Not Recruiting
23
Mount SInai Medical Center
New York, New York, United States, 10029
Actively Recruiting
24
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
25
MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH
New York, New York, United States, 10065-7471
Actively Recruiting
26
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
27
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
28
Duke Cancer Institute
Durham, North Carolina, United States, 27710-4000
Actively Recruiting
29
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45219
Actively Recruiting
30
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
31
Miriam Hospital
Providence, Rhode Island, United States, 02906
Actively Recruiting
32
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
33
Antwerp University Hospital
Edegem, VAN, Belgium, 2650
Actively Recruiting
34
ULB Hôpital Erasme
Brussels, Belgium, 1070
Actively Recruiting
35
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
36
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
37
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
38
St Michael Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
39
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
40
Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
Montreal, Quebec, Canada, H2L 4M1
Actively Recruiting
41
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
42
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037
Actively Recruiting
43
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
44
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
45
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
46
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
47
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, Germany, 13353
Actively Recruiting
48
Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital
Bochum, Germany, 44791
Actively Recruiting
49
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
50
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
51
Universitätsklinikum Essen
Essen, Germany, 45122
Actively Recruiting
52
Krankenhaus Nordwest GmbH
Frankfurt, Germany, 60488
Actively Recruiting
53
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
54
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
55
Ludwig-Maximilians-Universität München
München, Germany, 81377
Actively Recruiting
56
Klinikum Bogenhausen
München, Germany, 81925
Actively Recruiting
57
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
58
Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale
Ulm, Germany, 89081
Actively Recruiting
59
Uniklinikum Würzburg, Med. Klinik und Poliklinik II
Würzburg, Germany, 97080
Actively Recruiting
60
Amsterdam UMC Location VUMC
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
61
UMC Radboud Nijmegen
Nijmegen, Netherlands, 6500 HB
Actively Recruiting
62
Erasmus MC
Rotterdam, Netherlands, 3000 CA
Actively Recruiting
63
National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer
Goyang-si, South Korea, 410-769
Actively Recruiting
64
CHA Bundang Medical Center
Gyeonggi-do, South Korea, 13496
Actively Recruiting
65
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, South Korea, 06591
Actively Recruiting
66
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
67
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
68
Severance Hospital - Yonsei Cancer Center
Seoul, South Korea, 120-752
Actively Recruiting
69
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu, South Korea, 05505
Actively Recruiting
70
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
71
Hospital Regional Universitario de Malaga
Málaga, Malaga, Spain, 29010
Actively Recruiting
72
Clinica Universitaria de Navarra (CUN)
Pamplona/iruña, Navarre, Spain, 31008
Actively Recruiting
73
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
74
Hospital Universitario Vall d Hebron
Barcelona, Spain, 08035
Actively Recruiting
75
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
76
Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia
Madrid, Spain, 28027
Actively Recruiting
77
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
78
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
79
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Madrid, Spain, 28050
Actively Recruiting
80
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 41 343
Actively Recruiting
81
Karolinska Universitetssjukhuset
Solna, Sweden, 171 64
Actively Recruiting
82
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
83
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
84
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
85
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Actively Recruiting
86
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Actively Recruiting
87
Guys Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
88
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
89
University College London Cancer Institute
London, United Kingdom, WC1E 6DD
Actively Recruiting
Research Team
R
Reference Study ID Number: GO44479 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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