A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
Trial status: Open for Enrollment
Why is this study being done?
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.
Who is eligible to participate?
- 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.
- 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.