Infiltrating Bladder Urothelial Carcinoma Clinical Trial
Official title:
Pilot Study of Gemcitabine and Cisplatin Plus AGS-003-BLD in Patients With Muscle-Invasive Bladder Cancer Undergoing Neoadjuvant Cisplatin-Based Chemotherapy
This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.
PRIMARY OBJECTIVES:
I. To assess the immunogenicity of AGS-003-BLD in subjects with muscle invasive bladder
cancer.
SECONDARY OBJECTIVES:
I. To assess 1-year disease-free survival rate of patients with muscle-invasive bladder
cancer who receive cisplatin/gemcitabine chemotherapy plus AGS-003-BLD.
II. To determine the time to first metastatic lesion. III. To explore the disease-free and
overall survival of patients treated with this treatment combination.
IV. To evaluate the pathologic complete response (pCR) rate and identify any activity of this
treatment combination.
V. To evaluate toxicities and tolerability associated with this treatment combination.
VI. To assess the success rate of tumor procurement and AGS-003-BLD production of >= 5 doses.
TERTIARY OBJECTIVES:
I. To evaluate the relationships between pathologic complete response with the change in
CD28+ T cell levels.
II. To evaluate the change in frequency of CD11a highPD-1+ CD8+ T cells (and their expression
of Bim) in peripheral blood.
OUTLINE:
NEOADJUVANT PHASE: Patients receive gemcitabine hydrochloride intravenously (IV) on days 1
and 8, AGS-003-BLD intradermally (ID) on day 1, and cisplatin IV on day 1. Treatment repeats
every 21 days for up to 4 courses in the absence of disease progression or unacceptable
toxicity. Patients then receive AGS-003-BLD ID on day 1. Treatment repeats every 14 days for
up to 3 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo cystectomy during course 8.
ADJUVANT PHASE: Patients continue AGS-003-BLD ID on day 1 of course 9. Treatment repeats
every 12 weeks for up to 9 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
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