A Phase III Study Comparing Pembrolizumab Immunotherapy with Observation after Surgery for Localized Muscle-Invasive Bladder Cancer

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Full Title

Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (Ambassador) Versus Observation (A031501) (CIRB)

Purpose

Surgery is the standard treatment for patients with cancer of the bladder or urinary tract which has grown into the muscle layer or beyond. Some patients may receive chemotherapy before surgery, but for others, chemotherapy might not be safe. Depending on the amount of cancer left after surgery, the risk of the cancer coming back can be high in some patients.

In this study, researchers want to see if giving pembrolizumab after surgery in patients with high-risk localized muscle-invasive bladder cancer or cancers of the urinary tract is more effective for reducing recurrence and improving survival than observation alone. Pembrolizumab is an immunotherapy drug which is approved by FDA to treat bladder cancers which have already spread to other parts of the body. It boosts the power of the immune system to detect and destroy cancer cells. It is given intravenously (by vein).

Patients in this study will be randomly assigned to receive pembrolizumab every three weeks up to a year, or to be monitored with regular scans as per the standard of care (observation group).

Eligibility

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

  • Patients must have surgery for localized muscle-invasive bladder cancer at least 4 weeks but no more than 16 weeks before entering the study.
  • Patients must not be eligible for cisplatin-based chemotherapy or must have declined to receive this treatment.
  • Patients may not have previously received immunotherapy such as pembrolizumab.
  • 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. Min Yuen Teo at 646-888-4867.

Protocol

19-220

Phase

III

Investigator