Bladder Cancer Clinical Trial
Official title:
A Phase II, Open-Label Study of the CDX-1307 Vaccine Regimen as Neoadjuvant and Adjuvant Therapy in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer Expressing hCG-β
The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine regimen when it is given before and after bladder cancer surgery. The study will also provide information about the safety of the vaccine regimen when given in combination with chemotherapy, and how it affects the immune systems.
CDX-1307 is an experimental vaccine that is designed to generate an immune response against a
protein called human chorionic gonadotropin-beta (hCG-β). hCG-β is made by several types of
cancers, including bladder cancer, and has been shown to be associated with shorter times to
development of metastases and reduced survival in bladder cancer. In this study, it is hoped
that administering the CDX-1307 vaccine will cause the body's immune system to attack bladder
cancer cells in order to kill them or otherwise keep them from spreading or coming back.
Standard treatment for early stage, muscle invasive bladder cancer includes the
administration of chemotherapy to shrink the tumor followed by surgical removal of the
bladder (cystectomy).
This study will compare the effect of adding CDX-1307 administration to this standard
treatment. CDX-1307 will be given with 3 different immune stimulants to try to increase the
immune response against the tumor cells; collectively, this is called the "CDX-1307 vaccine
regimen."
Only patients whose tumors make the hCG-β protein will be included in this study. Eligible
patients will receive "standard of care" chemotherapy with the CDX-1307 vaccine regimen
before surgery, and then CDX-1307 vaccine regimen alone (without chemotherapy) after surgery.
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