A Pilot Study Assessing Immunotherapy with Nivolumab Alone or with Ipilimumab Before Surgery for Patients with Muscle-invasive Bladder Cancer Who Cannot Have Cisplatin-Based Chemotherapy

Full Title

IIT: A Pilot Study to Evaluate the Safety of Neoadjuvant Nivolumab Alone or in Combination with Ipilimumab for Cisplatin-Ineligible Patients with Muscle Invasive Bladder Cancer

Purpose

For patients with bladder cancer which has invaded the muscle wall, cisplatin-based chemotherapy before surgery is the preferred approach. However, not all patients can tolerate this treatment, due to inadequate kidney function, pre-existing nerve issues, and hearing impairment. These patients frequently proceed directly to surgery.

In this study, researchers want to see if using immunotherapy drugs before bladder cancer surgery - such as nivolumab alone or in combination with ipilimumab - can shrink the tumor and help make the surgery more successful. Immunotherapy may also treat cancer cells that may have already spread elsewhere in the body.

Patients in this study will receive nivolumab alone or nivolumab plus ipilimumab before bladder cancer surgery. Both drugs work by inhibiting proteins that normally put the brakes on the immune response, enhancing the power of the immune system to find and destroy cancer cells. They 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 muscle-invasive bladder cancer and be ineligible for cisplatin for health reasons.
  • Patients may have had BCG therapy more than 6 weeks before entering the study, but otherwise may not have received treatment for their bladder cancer.
  • 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 and to inquire about eligibility for this study, please contact Dr. Min Yuen Teo at 646-888-4867.

Protocol

18-042

Phase

Pilot

Investigator