JAVELIN Renal 101: This phase III trial is evaluating the safety and effectiveness of avelumab in combination with axitinib (an oral drug), and of sunitinib (an oral drug) monotherapy, for first line treatment in patients with advanced renal cell carcinomaA Phase 3, Multinational, Randomized, Open-Label, Parallel-Arm Study Of Avelumab (MSB0010718C) In Combination With Axitinib (Inlyta(Registered)) Versus Sunitinib (Sutent(Registered)) Monotherapy In The First-Line Treatment Of Patients With Advanced Renal Cell Carcinoma

Exclusion

• Prior systemic therapy directed at advanced or metastatic RCC
• Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
• Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
• Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
• Newly dignosed or active brain metastasis
• Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
• Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
• Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
• Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)