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Protocol No.1680GCCPrincipal InvestigatorMannuel, Heather
PhasePhase II
Age GroupAdult
TitleA Randomized, Double-Blinded, Phase II Study of Maintenance Pembrolizumab versus Placebo after First-line Chemotherapy in Patients with Metastatic Urothelial Cancer
DescriptionThis is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.
TreatmentPlacebo Comparator: Control Arm A Commercially available normal saline will be used as the placebo. No active placebo drug will be mixed with the normal saline. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months. Intervention: Other: Placebo Experimental: Experimental Arm B Pembrolizumab, 200mg IV every 3 weeks. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months. Intervention: Drug: Pembrolizumab
Key EligibilityInclusion Criteria:
-Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
-Age 18 years or older at the time of consent.
-ECOG Performance Status (PS) of 1 or greater than 1 within fourteen days of registration for protocol therapy.
-Histological or cytological evidence of urothelial cancer of the bladder, urethra, ureter, or renal pelvis. Differentiation with variant histologies (e.g., squamous cell differentiated) will be permitted provided that the predominant histology is urothelial carcinoma.
-Metastatic and/or unresectable (cT4b) disease
-Must have achieved an objective response (CR/PR) or stable disease (SD) after 4 to 6 cycles of standard first-line platinum-based chemotherapy for mUC (e.g., as per NCCN guidelines). Able to commence study treatment within 2 to 6 weeks of receiving last dose of first-line chemotherapy.
-All subjects must have adequate archival tissue available prior to registration (i.e., at least 20 unstained slides or paraffin block). If acceptable archival tissue is not available, the subject must be willing to consent to providing a core or excisional biopsy for research prior to registration for protocol therapy. If archival tissue is not available and there are no sites amenable to biopsy, enrollment must be discussed with the sponsor-investigator on a case by case basis.
-Adequate laboratory values obtained within 14 days prior to registration for protocol therapy.
-Female subjects of childbearing potential must have a negative serum pregnancy within three days prior to registration for protocol therapy
-Sexually active, pre-menopausal women of childbearing potential must be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > one year.
-Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.

Please go to clinicaltrials.gov and search NCT02500121 for more detailed information on eligibility for this study.
Applicable Disease SitesBladder
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02500121
ContactGreenebaum Comprehensive Cancer Center: Navid Saeidi, MS Phone:410-328-6465
Pager:410-328-2337 #7678
Email:Navid.saeidi@umm.edu
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