Javelin Bladder 100: This phase III trial is comparing maintenance treatment with avelumab and best standard care, with best standard care alone, in patients with advanced urothelial cancerA Phase 3, Multicenter, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab* (msb0010718c) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy

Exclusion

• Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
• Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse events not constituting a safety risk based on the investigator's judgement are acceptable.
• Patients with known symptomatic central nervous system (CNS) metastases requiring steroids
• Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.