A Phase II Study of MPDL3280A in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer

Protocol
14-090
Full Title
A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer
Phase
II
Purpose

Chemotherapy has been the standard treatment for urothelial bladder cancer that has spread and grown beyond the urinary tract. For some patients, standard “platinum-based” chemotherapy drugs (such as cisplatin) are not safe to give due to their side effects, and in many patients who have already received these drugs, the cancer later comes back.

In this study, researchers are evaluating the safety and effectiveness of an investigational drug called MPDL3280A in patients with locally advanced or metastatic urothelial cancer who cannot be treated with cisplatin or whose cancer has returned after platinum-based treatment. Two groups of patients will be eligible for this study:

  1. Patients who have never received platinum-based chemotherapy for urothelial cancer who are either unable to receive cisplatin or who have relapsed more than 12 months after receiving pre- or post-operative chemotherapy.
  2. Patients whose cancer has grown or spread after receiving at least two cycles of platinum-based chemotherapy, either for metastatic cancer or for relapse within 12 months after pre- or post-operative chemotherapy.

MPDL3280A is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced or metastatic urothelial cancer.
  • Patients must be either unable to be treated with cisplatin or carboplatin, or must have experienced a return of their urothelial cancer despite prior therapy with one of these drugs.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-422-4461.

Disease(s)
Bladder Cancer
Locations
Related Diseases