NL-OMON46995
Recruiting
Phase 2
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 (MSD)0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Merck Sharp & Dohme (MSD)
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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 per protocol.
- •3\. Have been treated with adequate BCG therapy and have developed high risk NMBIC 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\.)
- •7\. Demonstrate adequate organ function.
- •8\. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and be willing to use contraception in accordance with Section 5\.7\.2 of Protocol.
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 immunidefiency 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.
Outcomes
Primary Outcomes
Not specified
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