Cancer Type: BladderHospitals offering this trial
CALGB 90601: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma.
This study is for patients with advanced transitional cancer of the urinary tract (bladder cancer). The purpose of this study is to compare the effects of the combination of the chemotherapy drugs gemcitabine and cisplatin with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.
The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being dome to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of the cancer and allow patients to live longer.
Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Washington Hospital Center*
A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer
This study is for patients with bladder cancer.
The purpose of this study is to look at the effects, good or bad, of MPDL3280A on subjects with bladder cancer. MPDL3280A is an experimental drug, which means that health authorities such as the U.S. Food and Drug Administration (FDA) have not approved MPDL3280A for the treatment of bladder cancer or any other disease.
MPDL3280A is an antibody (a protein produced by the body’s immune system) that affects the immune system by blocking the programmed death-ligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the body’s natural immune response, but tumors can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD-L1 pathway, MPDL3280A may help the immune system stop or reverse the growth of tumors. All subjects on this trial will receive MPDL3280A as an infusion through a needle in a vein once every 3 weeks for up to a year.