Actively Recruiting
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)
Led by Hoffmann-La Roche · Updated on 2026-05-11
362
Participants Needed
107
Research Sites
152 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of the study is 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 saline + nivolumab arm.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and participate in the study
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper urinary tract
- Tumor classification of (y)pT3-4 or (y)pN+ and M0 according to pathological examination
- Surgical removal of muscle-invasive urothelial carcinoma
- Participants who had neoadjuvant chemotherapy, alone or with checkpoint inhibitors, are eligible
- Participants without prior neoadjuvant chemotherapy are eligible if ineligible for adjuvant cisplatin therapy or have refused it
- Tumor tissue available for biomarker analysis
- No residual disease or metastasis confirmed by recent CT or MRI scans within 28 days before randomization
- Full recovery from cystectomy or nephroureterectomy within 120 days after surgery
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Negative HIV test at screening
- Negative hepatitis B surface antigen test at screening
- Positive hepatitis B surface antibody or appropriate hepatitis B virus test results
- Negative hepatitis C virus antibody test or confirmed negative HCV RNA test at screening
You will not qualify if you...
- Partial cystectomy for bladder cancer or partial nephroureterectomy for renal pelvis tumor
- Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks before study treatment
- Adjuvant chemotherapy, immunotherapy, or radiation therapy for urothelial carcinoma after surgery
- Active malignancies within 3 years before randomization
- Treatment with live, attenuated vaccine within 4 weeks before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 107 locations
1
Highlands Oncology Group.
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Kaiser Permanente - Baldwin Park
Baldwin Park, California, United States, 91706
Actively Recruiting
3
City of Hope Cancer Center
Duarte, California, United States, 91010
Withdrawn
4
Kaiser Permanente - Los Angeles (N. Vermont)
Los Angeles, California, United States, 90027
Actively Recruiting
5
Kaiser Permanente - Riverside
Riverside, California, United States, 92505
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
7
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Withdrawn
8
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007
Withdrawn
9
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Withdrawn
10
Henry Ford Health System
Detroit, Michigan, United States, 48202
Withdrawn
11
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
12
MSK Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
13
MSK Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
14
MSK Commack
Commack, New York, United States, 11725
Actively Recruiting
15
MSK Westchester
Harrison, New York, United States, 10604
Actively Recruiting
16
Columbia University Irving Medical Center
New York, New York, United States, 10032
Withdrawn
17
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
18
MSK Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
19
Providence Portland Medical Ctr
Portland, Oregon, United States, 97225
Actively Recruiting
20
AHN Cancer Institute ? Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Withdrawn
21
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Withdrawn
22
Bon Secours - St. Francis Hospital
Greenville, South Carolina, United States, 29607
Withdrawn
23
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
24
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Withdrawn
25
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
26
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
27
Instituto Alexander Fleming
Buenos Aires, Argentina, 1426
Actively Recruiting
28
Hospital Britanico
Buenos Aires, Argentina, C1280AEB
Actively Recruiting
29
Hospital Italiano
Ciudad Autonoma Buenos Aires, Argentina, C1199ABB
Completed
30
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Actively Recruiting
31
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Withdrawn
32
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Actively Recruiting
33
UZ Gent
Ghent, Belgium, 9000
Withdrawn
34
AZ Groeninge
Kortrijk, Belgium, 8500
Withdrawn
35
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Withdrawn
36
Clinique Ste-Elisabeth
Namur, Belgium, 5000
Actively Recruiting
37
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
Withdrawn
38
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
39
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
40
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Completed
41
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Completed
42
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Actively Recruiting
43
Aarhus Universitetshospital
Aarhus N, Denmark, 8200
Actively Recruiting
44
Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
45
Hopital Claude Huriez
Lille, France, 59000
Actively Recruiting
46
Institut Paoli Calmettes
Marseille, France, 13273
Withdrawn
47
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer
Rennes, France, 35000
Actively Recruiting
48
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
49
Vivantes Klinikum Am Urban
Berlin, Germany, 10967
Completed
50
Universitätsklinikum Düsseldorf;Urologische Klinik
Düsseldorf, Germany, 40225
Actively Recruiting
51
Uniklinik Essen
Essen, Germany, 45122
Withdrawn
52
Uniklinik-Eppendorf
Hamburg, Germany, 20246
Withdrawn
53
Uniklinikum Heidelberg
Heidelberg, Germany, 69120
Completed
54
Marien Hospital Herne
Herne, Germany, 44625
Actively Recruiting
55
Universitätsklinikum Jena, Urologische Klinik und Poliklinik
Jena, Germany, 07747
Actively Recruiting
56
Klinikum rechts der Isar der TU München
München, Germany, 81675
Withdrawn
57
Klinikum Stuttgart - Katharinenhospital
Stuttgart, Germany, 70174
Actively Recruiting
58
Universitätsklinikum Ulm
Ulm, Germany, 89081
Active, Not Recruiting
59
Alexandras Hospital
Athens, Greece, 115 28
Actively Recruiting
60
Attikon University General Hospital
Athens, Greece, 124 61
Actively Recruiting
61
Theageneio Hospital
Thessaloniki, Greece, 546 39
Actively Recruiting
62
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Apulia, Italy, 70124
Actively Recruiting
63
Istituto Nazionale Tumori Irccs Fondazione G. Pascale
Naples, Campania, Italy, 80131
Withdrawn
64
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
65
IFO - Istituto Regina Elena
Rome, Lazio, Italy, 00144
Actively Recruiting
66
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy, 24127
Actively Recruiting
67
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy, 20089
Withdrawn
68
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piedmont, Italy, 10043
Actively Recruiting
69
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, Italy, 35128
Withdrawn
70
A.O.U di Verona Policlinico G.B. Rossi
Verona, Veneto, Italy, 37134
Actively Recruiting
71
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Actively Recruiting
72
CUAN Hospital
San Pedro Garza García, Nuevo León, Mexico, 66278
Withdrawn
73
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
74
St. Antonius locatie Leidsche Rijn
Utrecht, Netherlands, 3543 AZ
Withdrawn
75
Akershus universitetssykehus
Lørenskog, Norway, 1474
Completed
76
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, Poland, 85-796
Actively Recruiting
77
Szpital Wojewodzki im. M. Kopernika w Koszalinie
Koszalin, Poland, 75-581
Actively Recruiting
78
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, Poland, 20-090
Withdrawn
79
Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland, 10-228
Actively Recruiting
80
Radomskie Centrum Onkologii
Radom, Poland, 26-600
Actively Recruiting
81
AIDPORT Sp. z o. o.
Skórzewo, Poland, 60-185
Actively Recruiting
82
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, Poland, 02-781
Withdrawn
83
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 463-707
Actively Recruiting
84
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
85
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Withdrawn
86
Asan Medical Center
Seoul, South Korea, 05505
Active, Not Recruiting
87
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
88
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07014
Actively Recruiting
89
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
90
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Sant Andreu de la Barca, Barcelona, Spain, 08740
Actively Recruiting
91
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, Spain, 15706
Actively Recruiting
92
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
93
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
94
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
95
Instituto Valenciano Oncologia
Valencia, Spain, 46009
Actively Recruiting
96
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Actively Recruiting
97
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
98
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
99
Skånes Onkologiska Klinik, Universitetssjukhuset
Lund, Sweden, 22185
Withdrawn
100
Chang Gung Medical Foundation - Kaohsiung
Kaohisung, Taiwan, DUMMY_VALUE
Actively Recruiting
101
National Taiwan Uni Hospital
Taipei, Taiwan, 100
Withdrawn
102
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
103
Clatterbridge Cancer Centre
Bebington, United Kingdom, CH63 4JY
Withdrawn
104
Royal Devon and Exeter Hospital
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
105
Barts & London School of Med;Medical Oncology
London, United Kingdom, EC1M 6BQ
Actively Recruiting
106
Royal Preston Hosptial
Preston, United Kingdom, PR2 9HT
Withdrawn
107
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Withdrawn
Research Team
R
Reference Study ID Number: BO45230 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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