Intermittent Checkpoint Inhibitor Therapy for the Treatment of Advanced or Metastatic Urothelial Cancer

Inclusion Criteria

• Histological confirmation of urothelial carcinoma (any histology)
• Advanced or metastatic urothelial carcinoma
• Has received at least 20 weeks on CPI therapy per standard of care (SOC) for advanced urothelial carcinoma
• Karnofsky performance score (KPS) >= 70%
• Willing and able to provide informed consent
• Serum creatinine =< 2 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 30 mL/min (measured or calculated using the Cockcroft-Gault formula)
• Hemoglobin (Hb) >= 8.0 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
• Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)

Exclusion Criteria

• History of severe hypersensitivity reaction to any monoclonal antibody
• Patients are excluded if they have known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
• Major surgery (e.g., cystectomy) less than 28 days prior to the first dose of study drug
• Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 7 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
• Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
• Pregnant women are excluded from this study because animal studies have demonstrated that PD-1/PD-L1 inhibitors can cause fetal harm when administered to pregnant women. Breastfeeding women are excluded from this study because PD-1/PD-L1 inhibitors may be excreted in human milk and the potential for serious adverse reactions in nursing infants