Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma
M.D. Anderson Cancer Center
Summary
To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.
Description
Primary Objectives * To demonstrate efficacy of combination tivozanib and nivolumab in advanced non-clear cell renal cell carcinoma (nccRCC). Secondary Objectives * To assess the safety and toxicity of combination tivozanib and nivolumab. * To estimate the duration of clinical efficacy Exploratory Objectives * To associate immune and tumor biomarkers with clinical efficacy
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed metastatic non-clear cell renal cell carcinoma of papillary, chromophobe, oncocytic neoplasms, unclassified, or not otherwise specified (NOS) as clear cell. Medullary carcinoma of the kidney and collecting duct tumors are NOT allowed 2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 3. Up to 1 systemic line of therapy (either monotherapy or combination) including prior immunotherapy (anti-PD1, PD-L1, or CTLA-4) and multi-tyrosine kinase inhibitors in non-metastatic or metastatic s…
Interventions
- DrugTivozanib
Given by PO
- DrugNivolumab
Given by IV (vein)
Locations (5)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- UT Southwestern Medical CenterDallas, Texas
- M D Anderson Cancer CenterHouston, Texas