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Alliance A031501- Bladder Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study drug MK-3475 (pembrolizumab) is better, the same, or worse than the usual approach after surgery to remove muscle-invasive bladder cancer.

What is the Condition Being Studied?

Bladder Cancer

Who Can Participate in the Study?

Adults who:
- Have recently had their bladder removed
- Have no active autoimmune disease
- Are not pregnant or nursing

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (put into one of two groups by chance like the flip of a coin) and get either:
-- Group 1: study drug MK-3475 (pembrolizumab) by intravenous infusion once every 3 weeks for one year
-- Group 2: no study drug but followed with clinic visits every 6 weeks for one year
- Get a CT or MRI scans every 12 weeks for 2 years and then yearly for up to 5 years

Study Details

Full Title
Alliance A031501: Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma versus Observation (AMBASSADOR)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00089733
NCT:NCT03244384
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698