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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502404-73-00 | Registry Identifier | EU CT Number |
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| Name | Class |
|---|---|
| BioNTech SE | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX | Experimental | Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX. |
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| Arm 2: mFOLFIRINOX | Active Comparator | Participants will receive mFOLFIRINOX. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autogene cevumeran | Drug | Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO44479 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Atezolizumab | Drug | Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints. |
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| mFOLFIRINOX | Drug | mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints. |
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| Years 3 and 5 |
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 6 years |
| USC Norris Cancer Center |
| Recruiting |
| Newport Beach |
| California |
| 92663 |
| United States |
| University of California, San Francisco (UCSF) | Recruiting | San Francisco | California | 94158-2350 | United States |
| University of California Los Angeles | Recruiting | Santa Monica | California | 90404 | United States |
| St. Francis Hospital and Medical Center | Recruiting | Hartford | Connecticut | 06105 | United States |
| Smilow Cancer Center | Withdrawn | New Haven | Connecticut | 06510 | United States |
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06520 | United States |
| Smilow Cancer Hospital Care Center at Trumbull | Recruiting | Trumbull | Connecticut | 06611 | United States |
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
| Indiana University Health Melvin & Bren Simon Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky Medical Center | Recruiting | Lexington | Kentucky | 40536 | United States |
| Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center | Recruiting | Boston | Massachusetts | 02114-2621 | United States |
| Boston Medical Center (BMC) - Cancer Care Center | Recruiting | Boston | Massachusetts | 02118 | United States |
| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202-2610 | United States |
| University of Nebraska | Recruiting | Omaha | Nebraska | 68198-5300 | United States |
| Memorial Sloan Kettering Cancer Center Basking Ridge | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Cancer Center at Bergen | Recruiting | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Cancer Center - Commack | Recruiting | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center at Westchester | Recruiting | Harrison | New York | 10604 | United States |
| Northwell Health | Recruiting | Lake Success | New York | 11042 | United States |
| NYU Langone Health | Active, not recruiting | New York | New York | 10016 | United States |
| Mount SInai Medical Center | Recruiting | New York | New York | 10029 | United States |
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH | Recruiting | New York | New York | 10065-7471 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center at Nassau | Recruiting | Uniondale | New York | 11553 | United States |
| Duke Cancer Institute | Recruiting | Durham | North Carolina | 27710-4000 | United States |
| University of Cincinnati Cancer Institute | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
| Miriam Hospital | Recruiting | Providence | Rhode Island | 02906 | United States |
| Fred Hutchinson Cancer Research Center | Recruiting | Seattle | Washington | 98109 | United States |
| Antwerp University Hospital | Recruiting | Edegem | VAN | 2650 | Belgium |
| ULB Hôpital Erasme | Recruiting | Brussels | 1070 | Belgium |
| AZ Maria Middelares | Recruiting | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| St Michael Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital | Recruiting | Montreal | Quebec | H2L 4M1 | Canada |
| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Régional Universitaire de Lille | Recruiting | Lille | 59037 | France |
| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
| Institut Paoli Calmettes | Recruiting | Marseille | 13273 | France |
| Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54519 | France |
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) | Recruiting | Berlin | 13353 | Germany |
| Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital | Recruiting | Bochum | 44791 | Germany |
| Universitaetsklinikum Koeln | Recruiting | Cologne | 50937 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Recruiting | Dresden | 01307 | Germany |
| Universitätsklinikum Essen | Recruiting | Essen | 45122 | Germany |
| Krankenhaus Nordwest GmbH | Recruiting | Frankfurt | 60488 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| Universitaetsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
| Ludwig-Maximilians-Universität München | Recruiting | München | 81377 | Germany |
| Klinikum Bogenhausen | Recruiting | München | 81925 | Germany |
| Universitaetsklinikum Tuebingen | Recruiting | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale | Recruiting | Ulm | 89081 | Germany |
| Uniklinikum Würzburg, Med. Klinik und Poliklinik II | Recruiting | Würzburg | 97080 | Germany |
| Amsterdam UMC Location VUMC | Recruiting | Amsterdam | 1081 HV | Netherlands |
| UMC Radboud Nijmegen | Recruiting | Nijmegen | 6500 HB | Netherlands |
| Erasmus MC | Recruiting | Rotterdam | 3000 CA | Netherlands |
| National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer | Recruiting | Goyang-si | 410-769 | South Korea |
| CHA Bundang Medical Center | Recruiting | Gyeonggi-do | 13496 | South Korea |
| The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital) | Recruiting | Seocho | 06591 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | 13620 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Severance Hospital - Yonsei Cancer Center | Recruiting | Seoul | 120-752 | South Korea |
| University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC) | Recruiting | Songpa-gu | 05505 | South Korea |
| Institut Catala d?Oncologia Hospital Germans Trias i Pujol | Recruiting | Badalona | Barcelona | 08916 | Spain |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | Malaga | 29010 | Spain |
| Clinica Universitaria de Navarra (CUN) | Recruiting | Pamplona/iruña | Navarre | 31008 | Spain |
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario Vall d Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | 28007 | Spain |
| Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia | Recruiting | Madrid | 28027 | Spain |
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario 12 De Octubre | Recruiting | Madrid | 28041 | Spain |
| Centro Integral Oncológico Clara Campal Ensayos Clínicos START | Recruiting | Madrid | 28050 | Spain |
| Sahlgrenska Universitetssjukhuset | Recruiting | Gothenburg | 41 343 | Sweden |
| Karolinska Universitetssjukhuset | Recruiting | Solna | 171 64 | Sweden |
| Clatterbridge Cancer Centre Liverpool | Recruiting | Liverpool | LIV | L7 8YA | United Kingdom |
| Belfast City Hospital | Recruiting | Belfast | BT9 7AB | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Recruiting | Birmingham | B15 2TH | United Kingdom |
| Addenbrookes Hospital | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
| Barts Health NHS Trust | Recruiting | London | EC1A 7BE | United Kingdom |
| Guys Hospital | Recruiting | London | SE1 9RT | United Kingdom |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
| University College London Cancer Institute | Recruiting | London | WC1E 6DD | United Kingdom |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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