Phase II Trial of Gemcitabine, Cisplatin, plus Ipilimumab as First-line Treatment for Patients with Metastatic Urothelial Carcinoma
ID Number 12-0026Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to see the safety and effectiveness of Ipilimumab when given in combination with Gemcitabine and Cisplatin. Gemcitabine and Cisplatin is the standard treatment that is routinely given to patients with your condition. This research study is evaluating a drug called Ipilimumab in combination with gemcitabine and cisplatin. The study drug, Ipilimumab, is made by Bristol-Myers Squibb and is approved by the U.S. Food and Drug Administration (FDA) for the treatment of a type of skin cancer called melanoma. However, for the purposes of this study, Ipilimumab is considered investigational as the drug has not approved by the FDA for use in your type of cancer. It is only available in research studies for subjects like you with your medical condition. Experiments have shown that Ipilimumab can help activate the immune system and thus helping your body fight off the cancer. It is a class of drug called a human monoclonal antibody.
You may qualify to take part in this research study because you have a type of cancer called transitional cell carcinoma that cannot be operated on or has spread to other organs. Transitional cell carcinoma is a type of cancer that is usually from the bladder, but can also be from organs associated with the bladder, such as the ureters (tubes connecting the bladder with your kidneys).
Recruiting Patients: Yes