NCT01353222

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

A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Dendreon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multicenter, open-label, Phase 2 study. Subjects were randomized to either the investigational product, DN24-02, or to standard of care. Subjects randomized to the experimental arm received DN24-02 at 2-week intervals, for a total of 3 infusions. The study evaluated survival, disease-free survival, safety and the magnitude of the immune response between these 2 subject groups.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	DN24-02	DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
OTHER	Standard of Care	Observation only until documentation of disease recurrence.

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-05-13
• Last updated: 2017-05-25
• Results posted: 2017-05-25

Locations

60 sites across 1 country: United States