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GU Cancers 2019 | AMBASSADOR: pembrolizumab for locally advanced bladder cancer

Andrea Apolo, MD, of the National Cancer Institute, Bethesda, MD, speaks at the 2019 Genitourinary Cancers Symposium, held in San Francisco, CA. Dr Apolo discusses the aims, methods and results of the AMBASSADOR study (NCT03244384) of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma.

Transcript (edited for clarity)

So another poster that we have here is a trials and progress poster, and this is the ambassador trial. It’s a phase three trial for patients with muscle invasive urothelial carcinoma with adjuvant pembrolizumab. These are high risk patients that have muscle invasive disease...

So another poster that we have here is a trials and progress poster, and this is the ambassador trial. It’s a phase three trial for patients with muscle invasive urothelial carcinoma with adjuvant pembrolizumab. These are high risk patients that have muscle invasive disease. They either could have received cisplatinum-based chemotherapy in the neoadjuvant setting and had persistent muscle invasive disease, or they could be cisplatinum ineligible, and we know that a large population of muscle invasive bladder cancer patients are cisplatinum ineligible.

So these patients, after they undergo their radical surgery, can receive adjuvant pembrolizumab, and they are randomized to receive pembrolizumab versus observation. And the question really is does it make a difference to give the pembrolizumab early versus waiting until the patients develop metastatic disease because we know that these agents are now approved. There are multiple checkpoint inhibitors approved in a metastatic setting, so if the patient develops metastatic disease, they’re going to get a checkpoint inhibitor. So really, our question is does it change progression for survival or disease-free survival? Does it change overall survival to be giving pembrolizumab early?

So the trial is planned to enroll 739 patients, and it’s actively occurring now, and this is through the alliance. And we’re pretty excited about our accrual right now.

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