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)
NCT ID: NCT06534983
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
362 participants
INTERVENTIONAL
2024-12-09
2034-01-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Autogene Cevumeran + Nivolumab
Participants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints.
Autogene Cevumeran
Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.
Nivolumab
Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
Saline + Nivolumab
Participants will receive saline solution along with 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year.
Nivolumab
Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
Saline
Saline solution for IV infusion.
Interventions
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Autogene Cevumeran
Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.
Nivolumab
Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
Saline
Saline solution for IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma \[TCC\]) of the bladder or upper urinary tract
* Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control \[UICC\]/American Joint Committee on Cancer \[AJCC\] 7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0
* Surgical resection of MIUC of the bladder or upper tract
* Participants who have received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible
* Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant refusal, cisplatin ineligibility or investigator decision
* Tumor tissue must be provided for biomarker analysis
* Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization
* Full recovery from cystectomy or nephroureterectomy within 120 days following surgery
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Negative human immunodeficiency virus (HIV) test at screening
* Negative hepatitis B surface antigen (HbsAg) test at screening
* Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< 500 international units/milliliter (IU/mL)
* Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
Exclusion Criteria
* Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
* Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection
* Prior active malignancies within 3 years prior to randomization
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Highlands Oncology Group.
Springdale, Arkansas, United States
Kaiser Permanente - Baldwin Park
Baldwin Park, California, United States
City of Hope Cancer Center
Duarte, California, United States
Kaiser Permanente - Los Angeles (N. Vermont)
Los Angeles, California, United States
Kaiser Permanente - Riverside
Riverside, California, United States
University of California San Francisco
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Henry Ford Health System
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, United States
MSK Monmouth
Middletown, New Jersey, United States
MSK Bergen
Montvale, New Jersey, United States
MSK Commack
Commack, New York, United States
MSK Westchester
Harrison, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MSK Nassau
Uniondale, New York, United States
Providence Portland Medical Ctr
Portland, Oregon, United States
AHN Cancer Institute ? Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Bon Secours - St. Francis Hospital
Greenville, South Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Instituto Alexander Fleming
Buenos Aires, , Argentina
Hospital Britanico
Buenos Aires, , Argentina
Hospital Italiano
Ciudad Autonoma Buenos Aires, , Argentina
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Clinique Ste-Elisabeth
Namur, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus Universitetshospital
Aarhus N, , Denmark
Herlev Hospital
Herlev, , Denmark
Hopital Claude Huriez
Lille, , France
Institut Paoli Calmettes
Marseille, , France
Centre Eugene Marquis
Rennes, , France
Institut Gustave Roussy
Villejuif, , France
Vivantes Klinikum Am Urban
Berlin, , Germany
Universitätsklinikum Düsseldorf;Urologische Klinik
Düsseldorf, , Germany
Uniklinik Essen
Essen, , Germany
Uniklinik-Eppendorf
Hamburg, , Germany
Uniklinikum Heidelberg
Heidelberg, , Germany
Marien Hospital Herne
Herne, , Germany
Universitätsklinikum Jena, Urologische Klinik und Poliklinik
Jena, , Germany
Klinikum rechts der Isar der TU München
München, , Germany
Klinikum Stuttgart - Katharinenhospital
Stuttgart, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Alexandras Hospital
Athens, , Greece
Attikon University General Hospital
Athens, , Greece
Theageneio Hospital
Thessaloniki, , Greece
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Apulia, Italy
Istituto Nazionale Tumori Irccs Fondazione G. Pascale
Napoli, Campania, Italy
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna, Italy
IFO - Istituto Regina Elena
Rome, Lazio, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piedmont, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padua, Veneto, Italy
A.O.U di Verona Policlinico G.B. Rossi
Verona, Veneto, Italy
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Erasmus MC
Rotterdam, , Netherlands
St. Antonius locatie Leidsche Rijn
Utrecht, , Netherlands
Akershus universitetssykehus
Lørenskog, , Norway
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, , Poland
Szpital Wojewodzki im. M. Kopernika w Koszalinie
Koszalin, , Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, , Poland
Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, , Poland
Radomskie Centrum Onkologii
Radom, , Poland
AIDPORT Sp. z o. o.
Skórzewo, , Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, , Poland
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Sant Andreu de la Barca, Barcelona, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Instituto Valenciano Oncologia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skånes Onkologiska Klinik, Universitetssjukhuset
Lund, , Sweden
Chang Gung Medical Foundation - Kaohsiung
Kaohsiung City, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Clatterbridge Cancer Centre
Bebington, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Barts & London School of Med;Medical Oncology
London, , United Kingdom
Royal Preston Hosptial
Preston, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: BO45230 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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BO45230
Identifier Type: -
Identifier Source: org_study_id
2023-509023-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
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