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

NCT01353222 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2017-05-25

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Dendreon

    lead INDUSTRY

Principal Investigators

  • Robert Israel, MD · Valeant Pharmaceuticals North America LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353222 on ClinicalTrials.gov