Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)

Exclusion Criteria

• •Active brain metastases or leptomeningeal metastases
• •Any serious or uncontrolled medical disorder that may interfere with study treatment/interpretation
• •Prior malignancy active within the previous 3 years except for local or organ confined early stage cancer that has been apparently cured
• •Active, known, or suspected autoimmune disease
• •A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
• •Prior therapy with anti-tumor vaccines, any T cell co-stimulation or checkpoint pathways, or IPI-549
• •Prior surgery or gastrointestinal dysfunction that may affect drug absorption
• •Past medical history of interstitial lung disease
• •History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
• •Positive test for hepatitis B, C or HIV
• •Dependent on continuous supplemental oxygen