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A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy.

Cohort A Subjects with CIS at baseline (CIS only, Ta+CIS, T1+CIS)
1. Objective: To evaluate anti-tumor activity of pembrolizumab (MK-3475), with regards
to absence of high risk NMIBC or progressive disease, as determined by cystoscopy,
cytology, biopsy (if applicable) and radiologic imaging by central pathology and
radiology review.

2. Objective: To evaluate anti-tumor activity of pembrolizumab (MK-3475) in PD-L1
positive subjects with regards to absence of high risk NMIBC or progressive disease,
as determined by cystoscopy, cytology, biopsy (if applicable) and radiologic imaging by
central pathology and radiology review.

Cohort B Subjects without CIS at baseline (High Grade Ta or Any Grade T1)
1. Objective: To evaluate anti-tumor activity of pembrolizumab (MK-3475) with regards to
absence of high risk NMIBC or progressive disease, as determined by cystoscopy,
cytology, biopsy (if applicable) and radiologic imaging by central pathology and
radiology review.

2. Objective: To evaluate anti-tumor activity of pembrolizumab (MK-3475) in PD-L1
positive subjects with regards to absence of high risk NMIBC or progressive disease,
as determined by cystoscopy, cytology, biopsy (if applicable) and radiologic imaging by
central pathology and radiology review.

Protocol Number: 081602
Phase: Phase II
Applicable Disease Sites: Urinary Bladder
Drugs Involved: Pembrolizumab (MK-3475)
Principal Investigator: Saum Ghodoussipour
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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