Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers

Inclusion Criteria: * Must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease. Patients with ampullary carcinoma are not eligible. * Must have failed or are intolerant to one line of systemic treatment but no more than 2 prior lines of systemic chemotherapy for advanced BTC. Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence. * Age ≥ 18 * Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or 1. * Must have radiographic measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Life expectancy of at least 12 weeks (3 months). * For patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy; Lesions that have not been treated with local therapy must be present and measureable. * Must be able to understand and be willing to sign the writt…