Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR ) versus Observation

Protocol No
ALLIANCE-A031501-AMBASSAD
Principal Investigator
Kathryn Bylow
Phase
III
Summary
The purpose of this study is to compare any good and bad effects of using a drug called MK-3475 (pembrolizumab) after the removal of your muscle invasive bladder cancer. MK-3475 is a drug that uses a persons own immune system to treat cancer. This study will allow researchers to know whether treatment with MK-3475 is better, the same, or worse than the usual approach. To be better, the MK-3475 should increase life by 9 months or more, compared to observation alone. The use of MK-3475 could prevent your cancer from returning but it could also cause side effects. This immunotherapy drug, MK-3475, is already FDA-approved for use in other types of cancers, but for your type of cancer it is considered experimental. There will be about 739 people taking part in this study.
Description
Pembrolizumab in Treating Patients With Locally Advanced Bladder Cancer (AMBASSADOR)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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