A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy (Aveo AV-951-20-304)

This study is being done to find out if a new investigational drug combination, tivozanib, combined with nivolumab, helps treat renal cell cancer better than tivozanib alone.

Tivozanib is a drug that blocks the development of blood vessels that trigger the cancer cells to divide and grow. Results from the completed studies suggest that tivozanib is generally well tolerated with a good safety profile. Nivolumab is a cancer drug that works with your immune system to interfere with the growth and spread of cancer cells in the body.

This is a study to compare the effectiveness and safety of study treatment with tivozanib in combination with nivolumab to study treatment with tivozanib alone for subjects with refractory advanced renal cell cancer and to describe the pharmacokinetic (PK, to determine how the study drug is taken up, distributed through the body, and eliminated from the body) profile of tivozanib. Subjects with renal cell cancer who agree to be in this study and are qualified to be in this study will take either tivozanib and nivolumab or tivozanib alone.

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

• Adults 18 years of age or older
• Histologically or cytologically confirmed RCC with a clear cell component
• 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
  • An ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, or nivolumab
  • Postoperative or adjuvant systemic therapy can be counted as a prior ICI therapy as long as recurrence is detected within 6 months of completion of treatment, in which case it will be counted as a prior therapy for metastatic disease. One or 2 prior therapies for metastatic disease are permissible but one of the treatments must have been an ICI.
• Additional eligibility in protocol

• More than 2 prior lines of therapy in the advanced or metastatic setting
• History of life-threatening toxicity related to prior immune therapy
• Active, known, or suspected autoimmune disease
• Uncontrolled hypertension
• Prior treatment with tivozanib
• More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic setting
• Known central nervous system metastases other than stable, treated brain metastases
• Pregnancy/breastfeeding
• Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04987203