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

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
registration.

- 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
registration.

- 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
resection.

- Adjuvant radiation therapy for urothelial or prostatic carcinoma following surgical
resection.

- 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
registration.

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

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

- 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
objectives.