NCT06053658

Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.

Detailed 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

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tivozanib	Given by PO
DRUG	Nivolumab	Given by IV (vein)

Timeline

• Start date: 2024-01-05
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2023-09-26
• Last updated: 2026-04-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study