Clinical trial • Phase I/II • Oncology
PEMBROLIZUMAB for Muscle-invasive urothelial carcinoma | Urothelial carcinoma
Phase I/II trial of PEMBROLIZUMAB for Muscle-invasive urothelial carcinoma | Urothelial carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Muscle-invasive urothelial carcinoma | Urothelial carcinoma
- Trial Stage
- Phase I/II
- Drug Modality
- Monoclonal antibody | ADC | mRNA | Other
Key dates
- Initial CTIS Submission Date
- 13-11-2023
- First CTIS Authorization Date
- 28-03-2024
Trial design
Randomised, compare v940 plus pembrolizumab to placebo plus pembrolizumab (placebo to v940 + pembrolizumab). dosing/schedule not specified in provided summary.-controlled Phase I/II trial across 27 sites in France, Poland, Germany and others.
- Randomised
- Yes
- Comparator
- Compare V940 plus pembrolizumab to placebo plus pembrolizumab (placebo to V940 + pembrolizumab). Dosing/schedule not specified in provided summary.
- Target Sample Size
- 147
Eligibility
Recruits 147 Vulnerable population flag selected in the application. Subject information and informed consent forms are provided (multiple country-specific ICF documents listed); no explicit assent/parental consent procedures for minors are detailed in the provided summary..
- Vulnerable Population
- Vulnerable population flag selected in the application. Subject information and informed consent forms are provided (multiple country-specific ICF documents listed); no explicit assent/parental consent procedures for minors are detailed in the provided summary.
Inclusion criteria
- {"criterion_text":"- Has a histological diagnosis of UC"}
- {"criterion_text":"- Perioperative Cohort: Is ineligible to receive cisplatin according to protocol pre-defined criteria"}
- {"criterion_text":"- Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing"}
- {"criterion_text":"- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization"}
- {"criterion_text":"- Must provide a formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS)"}
- {"criterion_text":"- Adjuvant Cohort: Has muscle-invasive urothelial carcinoma (MIUC)"}
- {"criterion_text":"- Adjuvant Cohort: Has high-risk pathologic disease after radical resection"}
- {"criterion_text":"- Adjuvant Cohort: For participants who have not received cisplatin-based neoadjuvant chemotherapy, are ineligible to receive cisplatin according to protocol pre-defined criteria"}
- {"criterion_text":"- Perioperative Cohort: Has muscle-invasive bladder cancer (MIBC)"}
- {"criterion_text":"- Perioperative Cohort: Is deemed eligible for radical cystectomy (RC) and pelvic lymph node dissection (PLND) and agrees to undergo curative intent standard RC and PLND and neoadjuvant and adjuvant treatment per protocol"}
Exclusion criteria
- {"criterion_text":"- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention"}
- {"criterion_text":"- Perioperative Cohort: Has severe hypersensitivity to either V940, pembrolizumab, or enfortumab vedotin (EV) and/or any of their excipients"}
- {"criterion_text":"- Perioperative Cohort: Has ongoing sensory or motor neuropathy"}
- {"criterion_text":"- Perioperative Cohort: Has active keratitis or corneal ulcerations"}
- {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment ≤3 years prior to study randomization"}
- {"criterion_text":"- Has current pneumonitis/interstitial lung disease"}
- {"criterion_text":"- Has active infection requiring systemic therapy"}
- {"criterion_text":"- Has active hepatitis B and hepatitis C virus infection"}
- {"criterion_text":"- Adjuvant Cohort: Has received prior systemic anticancer therapy"}
- {"criterion_text":"- Adjuvant Cohort: Has received prior neoadjuvant therapy, with the exception of neoadjuvant cisplatin-based chemotherapy for MIUC"}
- {"criterion_text":"- Adjuvant Cohort: Has severe hypersensitivity to either V940 or pembrolizumab (MK-3475) and/or any of their excipients"}
- {"criterion_text":"- Perioperative Cohort: Has received any prior systemic treatment, cancer vaccine treatment, chemoradiation, and/or radiation therapy treatment for MIBC"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Adjuvant Cohort: Disease-Free Survival (DFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Adjuvant Cohort: Overall-Survival (OS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Adjuvant Cohort: Distant Metastasis-Free Survival (DMFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Adjuvant Cohort: Number of Participants Who Experience an AE","definition_or_measurement_approach":""}
- {"endpoint_text":"- Adjuvant Cohort: Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
- {"endpoint_text":"- Perioperative Cohort: Pathologic Complete Response (pCR) Rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Perioperative Cohort: Pathologic Downstaging (pDS) Rate","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 147
- Recruitment Window Months
- 90
- Consent Approach
- Informed consent is to be obtained using country-specific Subject Information and Informed Consent Forms (multiple L1_ICF documents listed for France, Germany, Italy, Spain, Sweden, Poland and English-language versions). Optional consent-related documents (eg. optional pregnancy partner, optional follow-up) and cohort-specific ICFs (Adjuvant and Perioperative cohorts) are provided. Consent is provided by the participant; no explicit assent/parental procedures for minors are described in the summary documents.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 90
France
- Latest Decision Or Authorization Date
- 19-03-2026
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Innovation Thérapeutique et des Essais Précoces
- Principal Investigator Name
- Yohann Loriot
- Principal Investigator Email
- yohann.loriot@gustaveroussy.fr
- Contact Person Name
- Yohann Loriot
- Contact Person Email
- yohann.loriot@gustaveroussy.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie
- Principal Investigator Name
- Sophie Abadie-Lacourtoisie
- Principal Investigator Email
- sophie.abadie-lacourtoisie@ico.unicancer.fr
- Contact Person Name
- Sophie Abadie-Lacourtoisie
- Contact Person Email
- sophie.abadie-lacourtoisie@ico.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Clement Dumont
- Principal Investigator Email
- clement.dumont@aphp.fr
- Contact Person Name
- Clement Dumont
- Contact Person Email
- clement.dumont@aphp.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Oncologie médical
- Principal Investigator Name
- Damien POUESSEL
- Principal Investigator Email
- pouessel.damien@iuct-oncopole.fr
- Contact Person Name
- Damien POUESSEL
- Contact Person Email
- pouessel.damien@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Urologie, Andrologie, Transplantation rénale
- Principal Investigator Name
- Gautier Marcq
- Principal Investigator Email
- gautier.marcq@chu-lille.fr
- Contact Person Name
- Gautier Marcq
- Contact Person Email
- gautier.marcq@chu-lille.fr
Poland
- Latest Decision Or Authorization Date
- 23-03-2026
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej.
- Principal Investigator Name
- Mariusz Kwiatkowski
- Principal Investigator Email
- sekretariat.odch@swk.med.pl
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- sekretariat.odch@swk.med.pl
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Onkologii Klinicznej
- Principal Investigator Name
- Dariusz Kucharczyk
- Principal Investigator Email
- badania.kliniczne@onkol.kielce.pl
- Contact Person Name
- Dariusz Kucharczyk
- Contact Person Email
- badania.kliniczne@onkol.kielce.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Układu Moczowego
- Principal Investigator Name
- Paweł Wiechno
- Principal Investigator Email
- badaniakliniczne@nio.gov.pl
- Contact Person Name
- Paweł Wiechno
- Contact Person Email
- badaniakliniczne@nio.gov.pl
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Principal Investigator Name
- Marcin Majek
- Principal Investigator Email
- marcin.majek@cr-center.pl
- Contact Person Name
- Marcin Majek
- Contact Person Email
- marcin.majek@cr-center.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Principal Investigator Name
- Bogdan Zurawski
- Principal Investigator Email
- badania.kliniczne@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Zurawski
- Contact Person Email
- badania.kliniczne@co.bydgoszcz.pl
Germany
- Latest Decision Or Authorization Date
- 24-03-2026
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik fuer Urologie
- Principal Investigator Name
- Marco Schnabel
- Principal Investigator Email
- mschnabel@csj.de
- Contact Person Name
- Marco Schnabel
- Contact Person Email
- mschnabel@csj.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Klinik und Poliklinik fure Urologie
- Principal Investigator Name
- Katharina Böhm
- Principal Investigator Email
- katharina.boehm.study@uniklinikum-dresden.de
- Contact Person Name
- Katharina Böhm
- Contact Person Email
- katharina.boehm.study@uniklinikum-dresden.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Urologische Klinik und Poliklinik
- Principal Investigator Name
- Margita Retz
- Principal Investigator Email
- margitta.retz@tum.de
- Contact Person Name
- Margita Retz
- Contact Person Email
- margitta.retz@tum.de
- Site Name
- Universitaetsklinikum Halle (Saale) AöR
- Department Name
- Universitaetsklinik und Poliklinik fuer Urologie
- Principal Investigator Name
- Georgios Gakis
- Principal Investigator Email
- direktor.urologie@uk-halle.de
- Contact Person Name
- Georgios Gakis
- Contact Person Email
- direktor.urologie@uk-halle.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik fuer Urologie
- Principal Investigator Name
- Maria de Santis
- Principal Investigator Email
- maria.de-santis@charite.de
- Contact Person Name
- Maria de Santis
- Contact Person Email
- maria.de-santis@charite.de
Spain
- Latest Decision Or Authorization Date
- 24-03-2026
- Number Of Sites
- 5
- Number Of Participants
- 17
Sites
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Principal Investigator Name
- Elena Almagro
- Principal Investigator Email
- elena.almagro@quironsalud.es
- Contact Person Name
- Elena Almagro
- Contact Person Email
- elena.almagro@quironsalud.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Pablo Gajate Borau
- Principal Investigator Email
- pgajateborau@gmail.com
- Contact Person Name
- Pablo Gajate Borau
- Contact Person Email
- pgajateborau@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Rafael Morales
- Principal Investigator Email
- rmorales@vhio.net
- Contact Person Name
- Rafael Morales
- Contact Person Email
- rmorales@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medical oncology
- Principal Investigator Name
- Begoña Pérez
- Principal Investigator Email
- bpvalderrama@gmail.com
- Contact Person Name
- Begoña Pérez
- Contact Person Email
- bpvalderrama@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Albert Font Pous
- Principal Investigator Email
- afont@iconcologia.net
- Contact Person Name
- Albert Font Pous
- Contact Person Email
- afont@iconcologia.net
Italy
- Latest Decision Or Authorization Date
- 27-03-2026
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giampaolo Tortora
- Principal Investigator Email
- giampaolo.tortora@policlinicogemelli.it
- Contact Person Name
- Giampaolo Tortora
- Contact Person Email
- giampaolo.tortora@policlinicogemelli.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Andrea Necchi
- Principal Investigator Email
- necchi.andrea@hsr.it
- Contact Person Name
- Andrea Necchi
- Contact Person Email
- necchi.andrea@hsr.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Sarah Scagliarini
- Principal Investigator Email
- SARAH.SCAGLIARINI@aocardarelli.it
- Contact Person Name
- Sarah Scagliarini
- Contact Person Email
- SARAH.SCAGLIARINI@aocardarelli.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giuseppe Procopio
- Principal Investigator Email
- Giuseppe.Procopio@istitutotumori.mi.it
- Contact Person Name
- Giuseppe Procopio
- Contact Person Email
- Giuseppe.Procopio@istitutotumori.mi.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Oncologia Medica 1
- Principal Investigator Name
- Giuseppe Fornarini
- Principal Investigator Email
- giuseppe.fornarini@hsanmartino.it
- Contact Person Name
- Giuseppe Fornarini
- Contact Person Email
- giuseppe.fornarini@hsanmartino.it
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- 4
- Name
- Fortrea Inc.
- Responsibilities
- Unblinded monitoring
- Name
- Almac
- Responsibilities
- 3
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"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":"Almac","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Q Squared Solutions LLC.","duties_or_roles":"4","organisation_type":"Industry"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Unblinded monitoring","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- EU/1/15/1024/002
- Maximum Dose
- 400 mg
- Investigational Product Name
- ENFORTUMAB VEDOTIN
- Active Substance
- Enfortumab vedotin
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 125 mg
- Investigational Product Name
- mRNA-4157
- Active Substance
- MRNA-4157
- Modality
- mRNA
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- INTRAMUSCULAR INJECTION
- Maximum Dose
- 1 mg
- Investigational Product Name
- Placebo to V940
- Modality
- Other
- Combination Treatment
- Yes
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