Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

Inclusion Criteria:

   - Radiographic disease progression during or following at least 6 weeks of treatment
   with ICI for locally advanced or metastatic RCC with a clear cell component either in
   first- or second-line treatment.

   - Subjects must have recovered from the adverse events of prior therapy to grade ≤ 1 or
   baseline.

   - Histologically or cytologically confirmed RCC with a clear cell component.

   - Measurable disease per RECIST criteria Version 1.1.

   - Eastern Cooperative Oncology Group performance status of 0 or 1.

   - All participants must follow protocol defined contraceptive measures.

Exclusion Criteria:

   - Subjects who received: a. A single agent tyrosine kinase inhibitor (TKI) in the first
   line setting followed by a single agent immune checkpoint inhibitor (ICI) in the
   second line setting; b. More than 2 prior lines of therapy in the advanced or
   metastatic setting.

   - History of life-threatening toxicity related to prior immune therapy.

   - Active autoimmune disease as well as those that required discontinuation of prior
   immuno-oncological (IO) therapy due to immune mediated AEs.

   - Uncontrolled hypertension.

   - More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic
   setting.

   - Subjects on immune suppressive therapy for organ transplant or subjects with a history
   of genetic or acquired immune suppression disease such as human immunodeficiency virus
   (HIV) [Patients with HIV who have CD4+ T-cell counts >350 cells/µL, without a history
   of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections, and
   are on established antiretroviral therapy which does not include a cytochrome P450
   (CYP)3A4 inducer, for at least 4 weeks and have an HIV viral load less than 400
   copies/mL, are eligible].

   - History of clinically significant interstitial lung disease or current non-infectious
   pneumonitis.