A Study of Presurgical Atezolizumab Immunotherapy with Gemcitabine and Cisplatin in Patients with Muscle-Invasive Bladder Cancer

Full Title

MCT: A Pilot Safety Study and Single Arm Phase II Study of Gemcitabine and Cisplatin with Atezolizumab (MPDL3280A) in Patients with Metastatic and Muscle Invasive Bladder Cancer, Respectively

Purpose

Atezolizumab is an immunotherapy drug approved to treat advanced bladder cancer that has continued growing after chemotherapy. It 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.

In this study, researchers want to see if combining atezolizumab with two other drugs, gemcitabine and cisplatin, is safe and effective for treating patients with metastatic bladder cancer. All three drugs are 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 metastatic bladder cancer.
  • Patients may not have had previous treatment with immunotherapy drugs that work in a manner similar to atezolizumab.
  • Patients may not have had prior gemcitabine and cisplatin for metastatic bladder cancer.
  • Patients may have had prior gemcitabine and cisplatin for localized bladder cancer, but at least one year must pass between the last dose and cancer progression.
  • Patients must have adequate hearing, kidney function, and heart function.
  • 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 for 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.

Protocol

16-1428

Phase

I/II

Investigator