A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305767
• Other study ID #: V940-005
• Secondary ID: V940-005U1111-12
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2024
• Est. completion date: April 8, 2031

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• Pembrolizumab
Administered via IV infusion at a dose of 400 mg on Day 1 of every 6-week cycle (Q6W) for up to 9 cycles.
• V940
Administered via IM injection at a dose of 1 mg every 3 weeks (Q3W) for up to 9 doses.

Other:
• Placebo
V940 diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.

Locations

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	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	klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit	Munich	Bayern
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
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

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC	ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  France,  Germany,  Italy,  New Zealand,  Poland,  Spain,  Sweden, 

Outcome

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

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary