drugset / Trial / NCT01353222

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

NCT01353222 ↗

Phase 2 Terminated 142 enrolled Dendreon
RandomizedParallel-groupOpen-labelTreatment

Summary

This study was conducted to examine survival, disease-free survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.

Timeline

Start
2011-06
Primary completion
2015-07
Completion
2015-07

Outcome

Missed primary endpoint

Stopped: “Administrative reasons.”

registry analysis (superiority test); DN24-02 vs Standard of Care; p = 0.6188; Hazard Ratio (HR) 1.141 (95% CI 0.679 to 1.918); NCT01353222 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject LAPULEUCEL-T Cell therapy — —

Indications