drugset / Trial / NCT05535218

Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer

NCT05535218

Phase 2 Active not recruiting 48 enrolled Claudia Guerrieri
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2, single-center, open-label, non-randomized study in patients with MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy. Patients will be consecutively enrolled and treated. All patients enrolled who receive at least 1 cycle of study drug will be included in the primary and secondary endpoint analyses.

Timeline

Start
2023-09-20
Primary completion
2027-02
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody 7.5 mg/kg Intravenous