A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy - Pembrolizumab (MK-3475) in high risk NMIBC patients unresponsive to BCG

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc0 sites320 target enrollmentMay 12, 2016

Overview

No summary available.

Registry

who.int

Start Date

May 12, 2016

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc

•1\.Have a histologically\-confirmed diagnosis of high risk non\-muscle\-invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder.
•2\.In subjects who have papillary tumors (Ta and T1\), a complete TURBT must have been performed, as characterized by:
•\- Attainment of a visually complete resection of all papillary tumors (Ta and T1\)
•\-Residual CIS not amenable to complete resection is
•\-The most recent cystoscopy/TURBT must have been performed within 12 weeks of randomization
•\-For Cohort C: subjects with T1 disease should have undergone a
•restaging TURBT procedure within 12 weeks prior to randomization to
•confirm complete resection.
•3\.Have been treated with adequate BCG therapy and have developed high risk NMIBC that is unresponsive to BCG therapy.
•4\.Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.

•1\.Has centrally\-assessed muscle invasive (i.e. T2, T3, T4\) locally advanced non\-resectable or metastatic urothelial carcinoma.
•2\.Has centrally\-assessed concurrent extra\-vesical (i.e. urethra, ureter or renal pelvis) non\-muscle invasive transitional cell carcinoma of the urothelium.
•3\.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•4\.Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment.
•5\.Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or who has not recovered (ie, \= Grade 1 or at baseline) from adverse events due to a previously administered agent.
•6\.Has a known additional malignancy that is progressing or requires active treatment.
•7\.7\. Has present or progressive accumulation of pleural, ascitic, or
•pericardial fluid requiring drainage or diuretic drugs within 2 weeks
•before randomization/study allocation for Cohort C.
•8\. Has severe hypersensitivity to pembrolizumab (all cohorts), MK\-