Last updated 8 days ago
A Clinical Study of V940 Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
230 patients around the world
Available in Chile, United States
Enrollment of participants into the Phase 1 Perioperative Cohort of this study is planned
to start in approximately April of 2025.
Merck Sharp & Dohme LLC
1Research sites
230Patients around the world
This study is for people with
Bladder Cancer
High Risk Muscle Invasive Bladder Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Oncocentro APYS - Viña del Mar
Recruiting
StudyINTerpath-005
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
High Risk Muscle Invasive Bladder Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06305767
