drugset / Trial / NCT07151560

Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial

NCT07151560

Phase 2 Not yet recruiting 60 enrolled Renmin Hospital of Wuhan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.

Timeline

Start
2025-08-30
Primary completion
2027-08-30
Completion
2030-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous
Subject Toripalimab Monoclonal antibody 2 mg/kg Intravenous
Subject Toripalimab Monoclonal antibody 3 mg/kg Intravenous

Indications

No indication recorded.