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 - Pembrolizumab (MK-3475) in high risk NMIBC patients unresponsive to BCG

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites260 target enrollmentJanuary 20, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
Enrollment: 260
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 20, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

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 transurethral resection is acceptable
•\- The most recent cystoscopy / TURBT must have been performed within 12 weeks of the first dose of trial treatment
•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\.)

Exclusion Criteria

•1\.Has muscle invasive (i.e. T2, T3, T4\) locally advanced non\-resectable or metastatic urothelial carcinoma.
•2\.Has 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 (i.e., \<\= 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\.Has an active autoimmune disease that has required systemic treatment in past 2 years.
•8 . Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
•9\. Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis
•10\.Has an active infection requiring systemic therapy, including active or intractable urinary tract infection (UTI) in the last month.