To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.
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
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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 setting is allowed. A washout period of 5 half lives or 21 days, whichever one is shorter, will be required for patients that have received previous systemic therapy.
Age ≥18 years.
Prior tivozanib therapy.
Prior nivolumab therapy.
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Patients who are receiving any other investigational agents.
Single group
Tivozanib
DrugGiven by PO
Nivolumab
DrugGiven by IV (vein)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
AVEO Pharmaceuticals, Inc.
Collaborator
