Clinical trial • Phase II • Oncology
MRNA-4157 for Bladder cancer
Phase II trial of MRNA-4157 for Bladder cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Bladder cancer
- Trial Stage
- Phase II
- Drug Modality
- mRNA | Vaccine
Key dates
- Initial CTIS Submission Date
- 16-12-2024
- First CTIS Authorization Date
- 23-04-2025
Trial design
Randomised, open-label, bcg vaccine (comparator), intravesical use (productname: 'bcg vaccine'); product metadata: maxdailydoseamount 50 mg; maxtreatmentperiod 1 (time unit code 1). detailed schedule/regimen not specified in the ctis record.-controlled Phase II trial in Netherlands, Spain, Greece and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- BCG VACCINE (comparator), intravesical use (productName: 'BCG VACCINE'); product metadata: maxDailyDoseAmount 50 mg; maxTreatmentPeriod 1 (time unit code 1). Detailed schedule/regimen not specified in the CTIS record.
- Target Sample Size
- 171
Eligibility
Recruits 171 No vulnerable populations selected (isVulnerablePopulationSelected = false). Informed consent documents for adult participants are available (country-specific ICFs listed); no paediatric assent/consent or other vulnerable-population consenting procedures are specified in the record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected = false). Informed consent documents for adult participants are available (country-specific ICFs listed); no paediatric assent/consent or other vulnerable-population consenting procedures are specified in the record.
Inclusion criteria
- {"criterion_text":"- Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before randomization/allocation and showed centrally-confirmed high-risk non-muscle invasive bladder cancer (NMIBC)\n- Cohort A: Is BCG-naïve defined as either having never received Bacillus Calmette–Guérin (BCG) or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG\n- Cohort B: Is either BCG-naïve (as defined above) or BCG-exposed who did not receive adequate dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG\n- Is an individual who can provide a tumor tissue sample that is suitable for the NGS and provide blood samples as specified in the study\n- Is an individual with a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 14 days before randomization/allocation\n- Cohort B only: Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)\n- Individuals who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization/allocation"}
Exclusion criteria
- {"criterion_text":"- Has a history of or concurrent locally-advanced or metastatic urothelial carcinoma (UC)\n- Has a known additional malignancy that is progressing or has required active treatment within the last 3 years\n- Had a myocardial infarction within 6 months of randomization/allocation\n- Cohort B only: Is HIV-infected individual with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation\n- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n- Has received prior treatment with a cancer vaccine\n- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization/allocation\n- Cohort A only: Has a known history of HIV infection\n- Active autoimmune disease that has required systemic treatment in the last 2 years\n- Active infection and/or diagnosis requiring systemic therapy\n- Cohort A only: Has a history of a hypersensitivity reaction to V940 and/or BCG and/or any of their excipients Cohort B only: Has a history of a hypersensitivity reaction to V940 and/or any of its excipients\n- Has not adequately recovered from major surgery or has ongoing surgical complications\n- Is incapacitated\n- Cohort A only: Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG\n- Cohort A only: Has current active tuberculosis\n- Has concurrent extravesical non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Cohort A: Event-Free Survival (EFS)\n- Cohort B: Complete Response Rate (CRR)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Cohort A: 12-month EFS Rate\n- Cohort A: 24-month EFS Rate\n- Cohort A: Recurrence-Free Survival (RFS)\n- Cohort A: Disease-Specific Survival (DSS)\n- Cohort A: Overall Survival (OS)\n- Cohort A: 12-month OS Rate\n- Cohort A: 24-month OS Rate\n- Cohort A: CRR\n- Cohort A: Duration of Response (DOR)\n- Cohort A: Time to Cystectomy\n- Cohort B: 6-month CRR\n- Cohort B: 12-month CRR\n- Cohort B: RFS\n- Cohort B: DSS\n- Cohort B: OS\n- Cohort B: Time to Cystectomy\n- Number of Participants who Experience an Adverse Event (AE)\n- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 171
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent obtained from adult participants. Country-specific subject information and informed consent forms are available (documents list includes adult ICFs and recruitment arrangements for Netherlands, Spain, Greece, Hungary, Italy, Denmark, Germany, Poland, France). No paediatric assent or other vulnerable-population consent procedures are specified.
Geography
- Total Number Of Sites
- 35
- Total Number Of Participants
- 138
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 360
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Urology
- Contact Person Name
- Carl Wijburg
- Contact Person Email
- studiesurologie@rijnstate.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Urology
- Contact Person Name
- Joost Boormans
- Contact Person Email
- urologie.ctc@erasmusmc.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 346
- Number Of Sites
- 6
- Number Of Participants
- 19
Sites
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Urology
- Contact Person Name
- Carlos Gonzalez Caliz
- Contact Person Email
- carlosgcaliz88@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Urology
- Contact Person Name
- Felix Guerrero Ramos
- Contact Person Email
- felixguerrero@gmail.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Elena Almagro Casado
- Contact Person Email
- elena.almagro@quironsalud.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Contact Person Name
- Javier Puente Vazquez
- Contact Person Email
- javierpuente.hcsc@gmail.com
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology
- Contact Person Name
- Alfonso Gomez de Liano Lista
- Contact Person Email
- agomlis@gobiernodecanarias.org
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Oncology
- Contact Person Name
- Teresa Bonfill Abella
- Contact Person Email
- tbonfill@tauli.cat
Greece
- Earliest CTIS Part Ii Submission Date
- 14-01-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 437
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
- Department Name
- Oncologic Clinical Trials and Research Clinic
- Contact Person Name
- Evangelos Bournakis
- Contact Person Email
- vagimith@yahoo.com
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4rth Oncology - Internal Medicine Department
- Contact Person Name
- Maria Lykka
- Contact Person Email
- marialykka@gmail.com
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd Propaedeutic Internal Medicine Department
- Contact Person Name
- Aristotelis Bamias
- Contact Person Email
- abamias@med.uoa.gr
- Site Name
- Athens Medical Center S.A.
- Department Name
- Oncology Department
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 386
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- University Of Debrecen
- Department Name
- Urológiai Klinika
- Contact Person Name
- Csaba Attila BERCZI
- Contact Person Email
- berczi@med.unideb.hu
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- Urológia
- Contact Person Name
- Zsófia PÓLYA
- Contact Person Email
- zsofiapolya@gmail.com
- Site Name
- Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
- Department Name
- Urológiai Osztály
- Contact Person Name
- Bassel MANSOUR
- Contact Person Email
- mansour.bassel.clinexpert@gmail.com
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Urológiai Osztály
- Contact Person Name
- András SZIGETI
- Contact Person Email
- drszigetia.petz@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 14-01-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 434
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Department Name
- Oncologia Medica
- Contact Person Name
- Alketa Hamzaj
- Contact Person Email
- alketa.hamzaj@uslsudest.toscana.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Struttura Complessa Oncologia Medica 1
- Contact Person Name
- Giuseppe Procopio
- Contact Person Email
- giuseppe.procopio@istitutotumori.mi.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Oncologia Medica 1
- Contact Person Name
- Fabio Calabrò
- Contact Person Email
- fabio.calabro@ifo.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Contact Person Name
- Gianpaolo Tortora
- Contact Person Email
- giampaolo.tortora@policlinicogemelli.it
Denmark
- Earliest CTIS Part Ii Submission Date
- 08-04-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 350
- Number Of Sites
- 2
- Number Of Participants
- 16
Sites
- Site Name
- Odense University Hospital
- Department Name
- Department of Urology
- Contact Person Name
- Lars Lund
- Contact Person Email
- Lars.Lund@rsyd.dk
- Site Name
- Region Hovedstaden
- Department Name
- Urinvejssygdomme
- Contact Person Name
- Ann Bersang
- Contact Person Email
- ann.kortbaek.bersang.01@regionh.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 14-04-2025
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 345
- Number Of Sites
- 5
- Number Of Participants
- 17
Sites
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Klinik für Urologie und Transplantationschirurgie
- Contact Person Name
- Jens Bedke
- Contact Person Email
- j.bedke@klinikum-stuttgart.de
- Site Name
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
- Department Name
- Zentrum für Uro-Onkologie der Ruhr-Universität Bochum
- Contact Person Name
- Florian Roghmann
- Contact Person Email
- florian.roghmann@elisabethgruppe.de
- Site Name
- Universitaetsklinikum Halle (Saale) AöR
- Department Name
- Universitätsklinik und Poliklinik für Urologie
- Contact Person Name
- Georgios Gakis
- Contact Person Email
- daniela.hesse@uk-halle.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Urologische Klinik und Poliklinik
- Contact Person Name
- Jozefina Casuscelli
- Contact Person Email
- jozefina.casuscelli@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Urologische Klinik und Poliklinik
- Contact Person Name
- Marc-Oliver Grimm
- Contact Person Email
- marc-oliver.grimm@med.uni-jena.de
Poland
- Earliest CTIS Part Ii Submission Date
- 13-03-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 379
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Układu Moczowego
- Contact Person Name
- Paweł Wiechno
- Contact Person Email
- badaniakliniczne@nio.qov.pl
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Contact Person Name
- Tomasz Piernik
- Contact Person Email
- kontakt@cr-center.p
- Site Name
- Szpital Wojewodzki Im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
- Department Name
- Oddział Urologiczny
- Contact Person Name
- Grzegorz Sulimka
- Contact Person Email
- urologia@lukasz.med.pl
France
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 341
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Foch
- Department Name
- Urology
- Contact Person Name
- Yann Neuzillet
- Contact Person Email
- y.neuzillet@hopital-foch.com
- Site Name
- Hopital Saint Louis
- Department Name
- Urology
- Contact Person Name
- Alexandra Masson-Lecomte
- Contact Person Email
- alexandra.massonlecomte@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Urology
- Contact Person Name
- Céline Duperron
- Contact Person Email
- celine.duperron@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Urology
- Contact Person Name
- Christian Pfister
- Contact Person Email
- christian.pfister@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Urology
- Contact Person Name
- Grégoire Robert
- Contact Person Email
- gregoire.robert@chu-bordeaux.fr
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Medidata Solutions Inc.
- Responsibilities
- Electronic Clinical Outcomes Assessment
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging Services including prospective collection of imaging scans and independent review of verification of disease.
- Name
- Almac Clinical Technologies LLC
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
- Name
- Pharmaceutical Product Development LLC
- Name
- Hematogenix Laboratory Services LLC
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic Clinical Outcomes Assessment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging Services including prospective collection of imaging scans and independent review of verification of disease.","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- mRNA-4157
- Active Substance
- MRNA-4157
- Modality
- mRNA
- Routes Of Administration
- INTRAMUSCULAR
- Route
- INTRAMUSCULAR
- Maximum Dose
- 9 mg (maxTotalDoseAmount)
- Investigational Product Name
- BCG VACCINE
- Modality
- Vaccine
- Routes Of Administration
- INTRAVESICAL USE
- Route
- INTRAVESICAL USE
- Maximum Dose
- 50 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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