Bladder Cancer

Clinical Trials

2014-0356

Title: A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer.

Description: 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.

For information on this study from ClinicalTrials.gov, click here!

2014-1305

Title: GO29294: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PDL1 Antibody) Compared with Chemotherapy in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer after Failure with Platinum-Containing Chemotherapy

Description:

The purpose of this study is to compare the effects, good or bad, of MPDL3280A versus chemotherapy on you and your urothelial bladder cancer (UBC) to find out which is better. In this study, you will get either MPDL3280A or chemotherapy (vinflunine, paclitaxel, or docetaxel).

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 your immune system stop or reverse the growth of tumors.

Subjects will be randomized on either MPDL3280A or chemotherapy arm and will receive study drug as an infusion through needle in a vein once every 3 weeks until clinical benefits are observed or there is progression of disease

For more information on this study from ClinicalTrials.gov, click here!