Patients
vitiligo, pneumonitis, cancers, neuropathy, malignancy, interstitial lung disease, psoriasis, infection, hypothyroidism, Cancer
DISORDER, VITILIGO, CANCERS, ADVERSE EVENT, HEPATITIS B, VIRUS, PNEUMONITIS, NEUROPATHY, INTERSTITIAL LUNG DISEASE, PSORIASIS, INFECTION, HEPATITIS C, TYPE I DIABETES MELLITUS, ONCOLOGY, HYPOTHYROIDISM, AUTOIMMUNE DISEASE, CANCER
Inclusion criteria:Written informed consent and HIPAA authorization for release of personal health information before registrationAge ≥18 years at the time of consentEastern Cooperative Oncology Group (ECOG) performance status of ≤1 within 28 d before registrationHistological evidence of clinically localized muscle-invasive UC of the bladder (that is, cT2N0M0)Candidate for cystectomy as per treating physicianAdequate organ functionAdequate archival tissue identified at screening (that is, at least 15 unstained slides or paraffin block)Women of childbearing potential must have a negative serum or urine pregnancy test within 7 d before cycle 1, day 1.Exclusion criteria:Prior treatment with systemic chemotherapy for muscle-invasive UC of the bladderActive infection requiring systemic therapyPregnant or breastfeedingAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy or interfere with the interpretation of study resultsPrior malignancy active within the previous 3 years except for locally curable cancers that have been apparently curedSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 d of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathwaysGrade ≥2 neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03)Prior radiation therapy for bladder cancerPositive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus RNA or hepatitis C antibody (HCV antibody), indicating acute or chronic infectionKnown history of testing positive for HIV or known AIDSEvidence of interstitial lung disease or active, non-infectious pneumonitis