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)

PHASE2RecruitingINTERVENTIONAL
Enrollment

362

Participants

Timeline

Start Date

December 9, 2024

Primary Completion Date

November 6, 2028

Study Completion Date

January 6, 2034

Conditions
Muscle Invasive Urothelial Carcinoma
Interventions
DRUG

Autogene Cevumeran

Autogene cevumeran will be administered as an IV infusion per the schedule in the specified arm.

DRUG

Nivolumab

Nivolumab will be administered as an IV infusion per the schedule in the specified arm.

DRUG

Saline

Saline solution for IV infusion

Trial Locations (96)

100

RECRUITING

National Taiwan Uni Hospital, Taipei

112

SUSPENDED

Taipei Veterans General Hospital, Taipei

1426

SUSPENDED

Instituto Alexander Fleming, Buenos Aires

1474

SUSPENDED

Akershus universitetssykehus, Lørenskog

2730

SUSPENDED

Herlev Hospital, Herlev

3000

SUSPENDED

UZ Leuven Gasthuisberg, Leuven

3021

RECRUITING

Sunshine Hospital, St Albans

3128

RECRUITING

Box Hill Hospital, Box Hill

5000

SUSPENDED

Clinique Ste-Elisabeth, Namur

5112

RECRUITING

Lyell McEwin Hospital, Elizabeth Vale

8200

SUSPENDED

Aarhus Universitetshospital, Aarhus N

8500

SUSPENDED

AZ Groeninge, Kortrijk

9000

SUSPENDED

UZ Gent, Ghent

SUSPENDED

Aalborg Universitetshospital, Aalborg

10032

SUSPENDED

Columbia University Irving Medical Center, New York

10043

SUSPENDED

A.O. Universitaria S. Luigi Gonzaga, Orbassano

10065

SUSPENDED

Memorial Sloan Kettering Cancer Center, New York

10604

SUSPENDED

MSK Westchester, Harrison

10967

SUSPENDED

Vivantes Klinikum Am Urban, Berlin

11553

SUSPENDED

MSK Nassau, Uniondale

11725

SUSPENDED

MSK Commack, Commack

15212

SUSPENDED

AHN Cancer Institute ? Allegheny General Hospital, Pittsburgh

15706

SUSPENDED

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela

20007

SUSPENDED

Georgetown University Medical Center Lombardi Cancer Center, Washington D.C.

20089

SUSPENDED

Istituto Clinico Humanitas, Rozzano

20246

SUSPENDED

Uniklinik-Eppendorf, Hamburg

22031

SUSPENDED

Inova Schar Cancer Institute, Fairfax

22185

SUSPENDED

Skånes Onkologiska Klinik, Universitetssjukhuset, Lund

24127

SUSPENDED

Asst Papa Giovanni XXIII, Bergamo

28040

SUSPENDED

Hospital Clinico San Carlos, Madrid

28046

SUSPENDED

Hospital Universitario La Paz, Madrid

35042

SUSPENDED

Centre Eugene Marquis, Rennes

35128

SUSPENDED

IOV - Istituto Oncologico Veneto - IRCCS, Padua

37134

SUSPENDED

A.O.U di Verona Policlinico G.B. Rossi, Verona

40138

SUSPENDED

AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica, Bologna

40207

SUSPENDED

Norton Cancer Institute, Louisville

40225

SUSPENDED

Universitätsklinikum Düsseldorf;Urologische Klinik, Düsseldorf

41013

SUSPENDED

Hospital Universitario Virgen del Rocio, Seville

44280

SUSPENDED

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44625

SUSPENDED

Marien Hospital Herne, Herne

45122

SUSPENDED

Uniklinik Essen, Essen

46009

SUSPENDED

Instituto Valenciano Oncologia, Valencia

46014

SUSPENDED

Hospital General Universitario de Valencia, Valencia

48202

SUSPENDED

Henry Ford Health System, Detroit

50009

SUSPENDED

Hospital Clinico Universitario Lozano Blesa, Zaragoza

59000

SUSPENDED

Hopital Claude Huriez, Lille

69120

SUSPENDED

Uniklinikum Heidelberg, Heidelberg

70124

SUSPENDED

A.O. Universitaria Ospedale Consorziale Policlinico Di Bari, Bari

72762

SUSPENDED

Highlands Oncology Group., Springdale

77030

SUSPENDED

MD Anderson Cancer Center, Houston

80131

SUSPENDED

Istituto Nazionale Tumori Irccs Fondazione G. Pascale, Napoli

81675

SUSPENDED

Klinikum rechts der Isar der TU München, München

89081

SUSPENDED

Universitätsklinikum Ulm, Ulm

91010

SUSPENDED

City of Hope Cancer Center, Duarte

92505

SUSPENDED

Kaiser Permanente - Riverside, Riverside

94158

SUSPENDED

University of California San Francisco, San Francisco

94805

SUSPENDED

Institut Gustave Roussy, Villejuif

97225

SUSPENDED

Providence Portland Medical Ctr, Portland

98109

SUSPENDED

Fred Hutchinson Cancer Research Center, Seattle

98195

SUSPENDED

University of Washington Medical Center, Seattle

07920

SUSPENDED

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge

07748

SUSPENDED

MSK Monmouth, Middletown

07645

SUSPENDED

MSK Bergen, Montvale

C1280AEB

RECRUITING

Hospital Britanico, Buenos Aires

C1199ABB

SUSPENDED

Hospital Italiano, Ciudad Autonoma Buenos Aires

T6G 1Z2

SUSPENDED

Cross Cancer Institute, Edmonton

M5G 1Z5

RECRUITING

Princess Margaret Cancer Center, Toronto

H3T 1E2

SUSPENDED

Jewish General Hospital, Montreal

H4A 3J1

SUSPENDED

McGill University Health Center, Montreal

07747

SUSPENDED

Universitätsklinikum Jena, Urologische Klinik und Poliklinik, Jena

115 28

SUSPENDED

Alexandras Hospital, Athens

124 61

SUSPENDED

Attikon University General Hospital, Athens

546 39

SUSPENDED

Theageneio Hospital, Thessaloniki

00144

SUSPENDED

IFO - Istituto Regina Elena, Rome

3015 GD

SUSPENDED

Erasmus MC, Rotterdam

3543 AZ

SUSPENDED

St. Antonius locatie Leidsche Rijn, Utrecht

85-796

SUSPENDED

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka, Bydgoszcz

75-581

SUSPENDED

Szpital Wojewodzki im. M. Kopernika w Koszalinie, Koszalin

20-090

SUSPENDED

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Lublin

10-228

SUSPENDED

Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn

26-600

SUSPENDED

Radomskie Centrum Onkologii, Radom

60-185

SUSPENDED

AIDPORT Sp. z o. o., Skórzewo

02-781

SUSPENDED

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Warsaw

463-707

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

03080

SUSPENDED

Seoul National University Hospital, Seoul

03722

SUSPENDED

Severance Hospital, Yonsei University Health System, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

07014

SUSPENDED

Hospital Universitario Son Espases, Palma de Mallorca

08740

SUSPENDED

Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Sant Andreu de la Barca

413 45

SUSPENDED

Sahlgrenska University Hospital, Gothenburg

Unknown

SUSPENDED

Chang Gung Medical Foundation - Kaohsiung, Kaohsiung City

EX2 5DW

RECRUITING

Royal Devon and Exeter Hospital, Exeter

EC1M 6BQ

SUSPENDED

Barts & London School of Med;Medical Oncology, London

PR2 9HT

SUSPENDED

Royal Preston Hosptial, Preston

SO16 6YD

SUSPENDED

Southampton General Hospital, Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BioNTech SE

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY