Pembrolizumab in MIBC

        Subject must meet all of the following applicable inclusion criteria to participate in thisudy:Written informed consent and HIPAA authorization for release of personal healthgistration. NOTE: HIPAA authorization may be included in thed consent or obtained separately.Age ≥ 18 years at the time of consent.COG Performance Status of ≤ 1 within 28 days prior to registration.Histological evidence of clinically localized muscle-invasive urothelial cancer of thebladder. Clinical stage cT2-3N0M0. N0 will be considered the absence ofdiographically enlarged lymph nodes on baseline imaging. Patients with lymph nodes<1 cm in long axis on imaging may be eligible but must be discussed with the sponsorvestigator.Have undergone a standard of care maximal transurethral resection of bladder tumor ≤60 days prior C1D1. Maximal TURBT is defined as a macroscopically complete resectionbladder tumor when safely possibly per the treating urologist. Patients who cannoty undergo maximal TURBT as per their treating urologist are eligible forbut should be discussed with the sponsor investigator.All subjects must have adequate transurethral resection of bladder tumor tissuevailable for submission (i.e., at least 15 unstained slides or paraffin block)dentified during screening. Subjects without available archival tissue must bediscussed with the sponsor-investigator.Decline cisplatin-based neoadjuvant chemotherapy or be considered cisplatin-ineligiblebased on at least one of the following modified criteria (as ECOG 0-1 is required forgibility):Creatinine clearance < 60 mL/min (but ≥ 30 mL/min)Grade ≥ 2 hearing loss (per CTCAE criteria v5)Grade ≥ 2 neuropathy (per CTCAE criteria v5)w York Heart Association Class III heart failureDemonstrate adequate organ function as defined below. All screening labs to bebtained within 28 days prior to registration.HematologicalAbsolute Neutrophil Count (ANC): ≥ 1.5 x 10^9/LHemoglobin (Hgb): ≥ 9 g/dLPlatelets: ≥ 100 x 10^9/LRenalCreatinine OR: Creatinine ≤ 1.5 × ULN ORCalculated creatinine clearance: creatinine clearance ≥ 30 mL/minHepaticBilirubin: ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with totalbilirubin levels > 1.5 × ULNAspartate aminotransferase (AST): ≤ 2.5 × ULNAlanine aminotransferase (ALT): ≤ 2.5 × ULNWomen of childbearing potential (WOCP) must have a negative serum or urine pregnancyum of 24-hours before the first dose of study drug. If the urine test isve or cannot be confirmed as negative, a serum pregnancy test will be required.WOCBP must agree to use contraception as outlined in the protocol.A male participant must agree to use contraception as detailed in the protocol.usion Criteria:ubjects meeting any of the criteria below may not participate in the study:Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.Prior malignancy active within the previous 2 years except for locally curable cancershat have been apparently cured. Patients with intermediate or lower risk prostatedefined by the National Comprehensive Cancer Network (NCCN) riskguidelines may be eligible for enrollment.Prior radiation therapy for bladder cancer.Active infection requiring systemic therapy.Has a known history of Hepatitis B or C. NOTE: Patients with a past or resolved HBV(defined as the presence of hepatitis B core antibody [anti-HBc] and absenceHBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligibley if polymerase chain reaction is negative for HCV RNA. NOTE: no testing forHepatitis B and Hepatitis C is required unless mandated by local health authority.Has a known history of Human Immunodeficiency Virus (HIV) infection. NOTE: no testingHIV is required unless mandated by local health authority.Has a known history of active TB (Bacillus Tuberculosis).Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while theher is being treated on study).Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or withgent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4,CD137).Has received a live or live-attenuated vaccine within 30 days prior to the first doseudy drug. Administration of killed vaccines is allowed.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 ofunosuppressive therapy within 7 days prior to the first dose of study drug.Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.Has active autoimmune disease that has required systemic treatment in the past 2 years(i.e. with use of disease modifying agents, corticosteroids or immunosuppressivedrugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroidherapy for adrenal or pituitary insufficiency, etc.) is not considered aystemic treatment and is allowed.Has a history of (non-infectious) pneumonitis/interstitial lung disease that requiredds or has current pneumonitis/interstitial lung disease.Has a history or current evidence of any condition, therapy, or laboratory abnormalityhat might confound the results of the study, interfere with the subject'she full duration of the study, or is not in the best interest ofhe subject to participate, in the opinion of the treating investigator.Has had an allogenic tissue/solid organ transplant.urrently receiving an investigational agent or has received an investigationalgent or used an investigational device within 28 days of study registration.