Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT06305767

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 15 Locations for this study

See Locations Near You

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102)
Orlando Florida, 32804, United States More Info
Study Coordinator
Contact
205-520-6512
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)
Macquarie University New South Wales, 2109, Australia More Info
Study Coordinator
Contact
0402856430
One Clinical Research ( Site 1807)
Nedlands Western Australia, 6009, Australia More Info
Study Coordinator
Contact
+61862799466
Centre Hospitalier de l'Université de Montréal ( Site 0005)
Montréal Quebec, H2X 3, Canada More Info
Study Coordinator
Contact
5148908000
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec City Quebec, G1J 1, Canada More Info
Study Coordinator
Contact
4185254444
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1503)
Santiago Region M. De Santiago, 83300, Chile More Info
Study Coordinator
Contact
56942477513
ONCOCENTRO APYS-ACEREY ( Site 1506)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56992369820
Hôpital Saint-Louis ( Site 0304)
Paris , 75010, France More Info
Study Coordinator
Contact
+33633211534
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
Munich Bayern, 81675, Germany More Info
Study Coordinator
Contact
498941402522
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland More Info
Study Coordinator
Contact
48501446778
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0802)
Koszalin Zachodniopomorskie, 75-58, Poland More Info
Study Coordinator
Contact
943488930
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005)
Madrid Madrid, Comunidad De, 28034, Spain More Info
Study Coordinator
Contact
+34913368263
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
+34914521987
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001)
Sevilla , 41013, Spain More Info
Study Coordinator
Contact
+34955012000
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102)
Uppsala Uppsala Lan, 751 8, Sweden More Info
Study Coordinator
Contact
+46736869248

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT06305767

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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