A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC)
Start Date
12/9/2024
Completion Date
11/10/2027
Summary
The original purpose of this study was to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the nivolumab monotherapy arm. Following the Sponsor's decision to phase out the study, as of Protocol Version 5, the primary purpose of the study is to ensure treatment continuity and safety for the participants who continue to participate in the study and receive study treatment.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Autogene Cevumeran
Nivolumab
Conditions
Locations
Highlands Oncology Group.
Springdale, Arkansas 72762
United States
Kaiser Permanente - Baldwin Park
Baldwin Park, California 91706
United States
City of Hope Cancer Center
Duarte, California 91010
United States
Kaiser Permanente - Los Angeles (N. Vermont)
Los Angeles, California 90027
United States
Kaiser Permanente - Riverside
Riverside, California 92505
United States
University of California San Francisco
San Francisco, California 94158
United States
Yale Cancer Center
New Haven, Connecticut 06520
United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia 20007
United States
Norton Cancer Institute
Louisville, Kentucky 40207
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey 07920
United States
MSK Monmouth
Middletown, New Jersey 07748
United States
MSK Bergen
Montvale, New Jersey 07645
United States
MSK Commack
Commack, New York 11725
United States
MSK Westchester
Harrison, New York 10604
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
MSK Nassau
Uniondale, New York 11553
United States
Providence Portland Medical Ctr
Portland, Oregon 97225
United States
AHN Cancer Institute ? Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Bon Secours - St. Francis Hospital
Greenville, South Carolina 29607
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States
University of Washington Medical Center
Seattle, Washington 98195
United States
Instituto Alexander Fleming
Buenos Aires, 1426
Argentina
Hospital Britanico
Buenos Aires, C1280AEB
Argentina
Hospital Italiano
Ciudad Autonoma Buenos Aires, C1199ABB
Argentina
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
Australia
Box Hill Hospital
Box Hill, Victoria 3128
Australia
Sunshine Hospital
St Albans, Victoria 3021
Australia
UZ Gent
Ghent, 9000
Belgium
AZ Groeninge
Kortrijk, 8500
Belgium
UZ Leuven Gasthuisberg
Leuven, 3000
Belgium
Clinique Ste-Elisabeth
Namur, 5000
Belgium
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul 90035-000
Brazil
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Princess Margaret Cancer Center
Toronto, Ontario M5G 1Z5
Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
McGill University Health Center
Montreal, Quebec H4A 3J1
Canada
Aalborg Universitetshospital
Aalborg, 9000
Denmark
Aarhus Universitetshospital
Aarhus N, 8200
Denmark
Herlev Hospital
Herlev, 2730
Denmark
Hopital Claude Huriez
Lille, 59000
France
Institut Paoli Calmettes
Marseille, 13273
France
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer
Rennes, 35000
France
Institut Gustave Roussy
Villejuif, 94805
France
Vivantes Klinikum Am Urban
Berlin, 10967
Germany
Universitätsklinikum Düsseldorf;Urologische Klinik
Düsseldorf, 40225
Germany
Uniklinik Essen
Essen, 45122
Germany
Uniklinik-Eppendorf
Hamburg, 20246
Germany
Uniklinikum Heidelberg
Heidelberg, 69120
Germany
Marien Hospital Herne
Herne, 44625
Germany
Universitätsklinikum Jena, Urologische Klinik und Poliklinik
Jena, 07747
Germany
Klinikum rechts der Isar der TU München
München, 81675
Germany
Klinikum Stuttgart - Katharinenhospital
Stuttgart, 70174
Germany
Universitätsklinikum Ulm
Ulm, 89081
Germany
Alexandras Hospital
Athens, 115 28
Greece
Attikon University General Hospital
Athens, 124 61
Greece
Theageneio Hospital
Thessaloniki, 546 39
Greece
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Apulia 70124
Italy
Istituto Nazionale Tumori Irccs Fondazione G. Pascale
Naples, Campania 80131
Italy
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna 40138
Italy
IFO - Istituto Regina Elena
Rome, Lazio 00144
Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy 24127
Italy
Istituto Clinico Humanitas
Rozzano, Lombardy 20089
Italy
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piedmont 10043
Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto 35128
Italy
A.O.U di Verona Policlinico G.B. Rossi
Verona, Veneto 37134
Italy
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco 44280
Mexico
CUAN Hospital
San Pedro Garza García, Nuevo León 66278
Mexico
Erasmus MC
Rotterdam, 3015 GD
Netherlands
St. Antonius locatie Leidsche Rijn
Utrecht, 3543 AZ
Netherlands
Akershus universitetssykehus
Lørenskog, 1474
Norway
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 85-796
Poland
Szpital Wojewodzki im. M. Kopernika w Koszalinie
Koszalin, 75-581
Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, 20-090
Poland
Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, 10-228
Poland
Radomskie Centrum Onkologii
Radom, 26-600
Poland
AIDPORT Sp. z o. o.
Skórzewo, 60-185
Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, 02-781
Poland
Seoul National University Bundang Hospital
Seongnam-si, 463-707
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands 07014
Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Sant Andreu de la Barca, Barcelona 08740
Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna 15706
Spain
Hospital Clinico San Carlos
Madrid, 28040
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Instituto Valenciano Oncologia
Valencia, 46009
Spain
Hospital General Universitario de Valencia
Valencia, 46014
Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Spain
Sahlgrenska University Hospital
Gothenburg, 413 45
Sweden
Skånes Onkologiska Klinik, Universitetssjukhuset
Lund, 22185
Sweden
Chang Gung Medical Foundation - Kaohsiung
Kaohisung, DUMMY_VALUE
Taiwan
National Taiwan Uni Hospital
Taipei, 100
Taiwan
Taipei Veterans General Hospital
Taipei, 112
Taiwan
Clatterbridge Cancer Centre
Bebington, CH63 4JY
United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
United Kingdom
Barts & London School of Med;Medical Oncology
London, EC1M 6BQ
United Kingdom
Royal Preston Hosptial
Preston, PR2 9HT
United Kingdom
Southampton General Hospital
Southampton, SO16 6YD
United Kingdom