Bladder Cancer Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | April 8, 2031 |
| Est. primary completion date | October 8, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has muscle-invasive urothelial carcinoma (MIUC) - Has dominant histology of UC - Has high-risk pathologic disease after radical resection - Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS) - Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization Exclusion Criteria: - Has received prior systemic anticancer therapy - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention - Has known additional malignancy that is progressing or has required active treatment <3 years prior to study randomization - Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients - Has current pneumonitis/interstitial lung disease - Has active infection requiring systemic therapy - Has active hepatitis B and hepatitis C virus infection |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Macquarie University-MQ Health Clinical Trials Unit ( Site 1803) | Macquarie University | New South Wales |
| Australia | One Clinical Research ( Site 1807) | Nedlands | Western Australia |
| Canada | Centre Hospitalier de l'Université de Montréal ( Site 0005) | Montréal | Quebec |
| Canada | Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 | Quebec City | Quebec |
| Canada | Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer | Sherbrooke | Quebec |
| Chile | Bradfordhill-Clinical Area ( Site 1501) | Santiago | Region M. De Santiago |
| Chile | FALP ( Site 1500) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1503) | Santiago | Region M. De Santiago |
| Chile | ONCOCENTRO APYS-ACEREY ( Site 1506) | Viña del Mar | Valparaiso |
| France | Institut de Cancérologie de l'Ouest ( Site 0300) | ANGERS cedex 02 | Maine-et-Loire |
| France | Hôpital Saint-Louis ( Site 0304) | Paris | |
| France | Gustave Roussy ( Site 0303) | Villejuif | Val-de-Marne |
| Germany | Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405) | Dresden | Sachsen |
| Germany | klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit | Munich | Bayern |
| Germany | Caritas-Krankenhaus St. Josef-Klinik für Urologie ( Site 0404) | Regensburg | Bayern |
| Italy | Ospedale San Martino-U.O. Oncologia Medica 1 ( Site 0500) | Genova | Liguria |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502) | Milan | Lombardia |
| Italy | Ospedale San Raffaele-Oncologia Medica ( Site 0501) | Milano | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504) | Roma | Lazio |
| New Zealand | Auckland City Hospital ( Site 1901) | Auckland | |
| Poland | Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0802) | Koszalin | Zachodniopomorskie |
| Poland | Clinical Research Center Spólka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k ( Site 0805) | Poznan | Wielkopolskie |
| Spain | Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006) | Badalona | Barcelona |
| Spain | Hospital Universitari Vall d'Hebron-Oncology ( Site 1002) | Barcelona | |
| Spain | Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005) | Madrid | Madrid, Comunidad De |
| Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003) | Pozuelo de Alarcon | Madrid |
| Spain | HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001) | Sevilla | |
| Sweden | Karolinska Universitetssjukhuset Solna ( Site 1101) | Stockholm | Stockholms Lan |
| Sweden | Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102) | Uppsala | Uppsala Lan |
| United States | AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102) | Orlando | Florida |
| United States | Fox Chase Cancer Center ( Site 0106) | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC | ModernaTX, Inc. |
United States, Australia, Canada, Chile, France, Germany, Italy, New Zealand, Poland, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease Free Survival (DFS) | DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (=pT2) disease in the urothelial tract (upper tract or lower tract) or high grade T1 disease in the upper tract on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for each arm. | Up to approximately 28 months | |
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for each arm. | Up to approximately 28 months | |
| Secondary | Distant Metastasis-Free Survival (DMFS) | DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for each arm. | Up to approximately 28 months | |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience AEs will be reported for each arm. | Up to approximately 16 months | |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an adverse event will be presented. The number of participants who discontinue study treatment due to an AE will be reported for each arm. | Up to approximately 13 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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