A Phase III Study of Atezolizumab Immunotherapy versus Observation After Bladder Removal Surgery in Patients with Muscle-Invasive Bladder Cancer

Full Title

A Phase III, Open-label, Multicenter, Randomized Study of MPDL3280A (Anti-PDL1 Antibody) versus Observation as Adjuvant Therapy in Patients with PD-L1-Selected, High-Risk Muscle-Invasive Bladder Cancer after Cystectomy

Purpose

Bladder cancers that invade the muscle wall of the bladder have a high risk of returning. Patients with these cancers typically have their bladders removed and are then monitored to see if the cancer comes back. In this study, researchers want to see if the drug atezolizumab can reduce the risk of cancer recurrence after bladder removal surgery for muscle-invasive bladder cancer.

Atezolizumab is a form of immunotherapy. 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. It is approved for treating advanced bladder cancer; its use in this study is considered investigational.

Atezolizumab is given intravenously (by vein). Patients in this study will be randomly assigned to receive atezolizumab or observation only (no treatment).

Eligibility

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

  • Patients must have muscle-invasive bladder cancer and have surgery to remove the bladder.
  • Patients may have had chemotherapy or radiation therapy before surgery, but not after surgery. At least 3 weeks must pass between completion of prior therapy and entry into the study.
  • Patients must have declined or must not be eligible to receive adjuvant chemotherapy with cisplatin.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • 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

15-291

Phase

III

Investigator