A Phase 3 Randomized Double-blind Matching Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992) | NYU Langone Health

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A Phase 3 Randomized Double-blind Matching Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Urinary Bladder Neoplasms
Age: Between 18 Year(s) - 100 Year(s)
Gender: Male or Female

Other Inclusion Criteria:

1. Has a histologically confirmed diagnosis of MIBC with predominant urothelial histology obtained. 2. Has clinically non-metastatic bladder cancer (N0M0) determined by imaging (CT of the chest and CTU/MRU of abdomen and pelvis), confirmed by BICR.

You may not be eligible for this study if the following are true:

1. Has the presence of diffuse CIS (multiple foci of CIS) throughout the bladder. 2. Has the presence of UC at any site outside of the urinary bladder in the previous 2 years except for Ta/T1/CIS of the upper tract if the patient has undergone a complete nephroureterectomy. 3. Has the presence of any small cell or neuroendocrine component in the tumor tissue sample.