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

Phase 2
18 Years
Open (Enrolling)
Urothelial Carcinoma

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Trial Information

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

This is a multicenter, open-label, Phase 2 study. Subjects will be randomized to either the
investigational product, DN24-02, or to standard of care. The purpose of this study is to
compare the length of survival between these 2 groups of subjects. Other purposes of the
study are to learn about the safety of DN24-02, to learn if it delays the time until
urothelial cancer recurs, and to learn if the immune system responds to treatment with
DN24-02. All subjects will be followed for this study for the remainder of their lives.

Inclusion Criteria:

- Histopathologic evidence of urothelial carcinoma at high risk of recurrence.

- Radical surgical resection was performed ≤ 84 days (12 weeks) prior to registration.

- No evidence of residual disease or metastasis on CT scan of chest, abdomen and pelvis
obtained at least 28 days following surgical resection and ≤ 28 days prior to

- HER2/neu tissue expression ≥ 1+ by immunohistochemistry (IHC). Available biopsy
specimens from the primary tumor and involved lymph nodes are be submitted to the
central pathology laboratory prior to registration for confirmation of HER2/neu
tissue expression.

- Last neoadjuvant chemotherapy treatment administered at least 60 days prior to

- Left ventricular ejection fraction ≥ 50% on MUGA scan or echocardiogram obtained at
least 28 days following surgery and ≤ 28 days prior to registration.

- Women of child-bearing potential have a negative serum pregnancy test result ≤ 28
days prior to registration and agree not to breastfeed during investigational
treatment with DN24-02 and for 28 days following the final infusion of DN24-02.

- All males and premenopausal females who have not been surgically sterilized have
agreed to practice a method of birth control considered by the Investigator to be
effective and medically acceptable for at least 14 days prior to registration,
throughout treatment, and for 28 days following the final infusion of DN24-02.

- Adequate hematologic, renal, and liver function.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

- A history of stage III or greater non-urothelial cancer. Exceptions include: Subject
with basal or squamous cell skin cancers that have been adequately treated who are
disease-free at the time of registration. Subjects who have been disease-free and off
treatment for ≥ 10 years at the time of registration.

- A history of stage I or II non-urothelial cancer. Exceptions include: Subjects who
have been disease-free and off treatment for ≥ 3 years at the time of
registration;subjects with incidental prostate cancer diagnosed at the time of
cystoprostatectomy; subjects with basal or squamous cell skin cancer.

- Partial cystectomy in the setting of bladder cancer primary tumor.

- Partial nephrectomy in the setting of renal pelvis primary tumor.

- Adjuvant systemic therapy for urothelial or prostatic carcinoma following surgical

- Adjuvant radiation therapy for urothelial or prostatic carcinoma following surgical

- Incidental prostate cancer with detectable post-operative (radical
cystoprostatectomy) PSA levels ≤ 28 days prior to registration.

- Any major surgery (e.g., surgery requiring general anesthesia) ≤ 28 days prior to

- Systemic treatment on any investigational clinical trial ≤ 28 days prior to

- Systemic glucocorticoid or immunosuppressive therapy use ≤ 28 days prior to

- Any infection requiring parenteral antibiotic therapy or causing fever (i.e.,
temperature > 100.5°F or > 38.1°C) ≤ 7 days prior to registration.

- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to DN24-02 or GM-CSF.

- Any medical intervention, has any other condition, or has any other circumstance
which, in the opinion of the Investigator or the Dendreon Medical Monitor, could
compromise adherence with study requirements or otherwise compromise the study's

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate overall survival following administration of DN24-02

Outcome Time Frame:

Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 5 years)

Safety Issue:


Principal Investigator

Robert Sims, MD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Urothelial Carcinoma
  • Bladder cancer
  • Renal pelvis cancer
  • Ureteral cancer
  • Urethral cancer
  • Bladder
  • Renal pelvis
  • Ureter
  • Urethra
  • Immune therapy
  • Immunotherapy
  • Vaccine
  • Dendritic cells
  • Antigen-presenting cells
  • Antigen presenting cells
  • Cancer vaccine
  • Urothelial carcinoma
  • Urothelial neoplasms
  • Neoplasms by site
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell



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Sentara Leigh Hospital Norfolk, Virginia  23502
Urology of Virginia, PLLC Virginia Beach, Virginia  23462
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Neag Comprehensive Cancer Center/University of Connecticut Health Center Farmington, Connecticut  06030
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital Atlanta, Georgia  30322
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