Atezolizumab Given in Combination With a Personalized Vaccine in Patients With Urothelial Cancer

Exclusion Criteria

• •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
• •Symptomatic CNS metastases and/or metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm) and/or history of intracranial hemorrhage or spinal cord hemorrhage
• •Pregnancy, lactation, or breastfeeding
• •Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• •History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
• •Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
• •Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
• •Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
• •History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• •o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• •History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection
• •Active tuberculosis
• •A known additional primary malignancy that is progressing or requires active treatment. Exceptions include cancers that have undergone potentially curative therapy.
• •* Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents
• •* No history of severe immune-related adverse effects from anti-CTLA 4 (NCI CTCAE Grade 3 and 4)
• •* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• •* Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation