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 LLC0 sites320 target enrollmentDecember 10, 2015

Conditionson-Muscle Invasive Bladder Cancer (NMIBC)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA (pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on-Muscle Invasive Bladder Cancer (NMIBC)
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 320
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 10, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Eligibility Criteria

Inclusion Criteria

•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 allowed
•\-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.
•5\. Have provided tissue for biomarker analysis from the most recent cystoscopy/TURBT procedures from which tumor sample is available.
•6\. Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. (Max of 5% ECOG of 2\.) (for cohorts A and B only)

Exclusion Criteria

•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 has had progression or has required active treatment in the last three years
•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\-7684A (Cohort C arm 1\), MK\-4280A (Cohort C Arm 2\), and/or any of their excipients.
•9\. Has an active autoimmune disease that has required systemic treatment in past 2 years.
•10\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.