Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer

Renal Cell Carcinoma Clinical Trial

Official title: A Phase 2 Study of Neoadjuvant Cabozantinib in Patients With Locally Advanced Non-Metastatic Clear Cell Renal Cell Carcinoma

Status Active, not recruiting

Clinical Trial Summary

This phase II clinical trial studies how well cabozantinib works in treating patients with kidney cancer before surgery. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To assess the objective response rate (complete and partial responses), following the administration of cabozantinib for 12 weeks in patients with locally advanced biopsy-proven non-metastatic clear cell renal cell carcinoma (ccRCC) prior to undergoing surgery.

SECONDARY OBJECTIVES:

I. To assess the safety, and tolerability of neoadjuvant cabozantinib.

II. To determine the clinical outcome (disease-free survival [DFS], overall survival [OS]) of patients with non-metastatic ccRCC who treated with neoadjuvant cabozantinib.

III. To evaluate the surgery related outcomes.

IV. To evaluate correlative studies, including biomarkers, quality of life, and frailty/sarcopenia assessment of patients with non-metastatic ccRCC who treated with neoadjuvant cabozantinib.

OUTLINE:

Patients receive cabozantinib orally (PO) once daily (QD) for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Renal Cell Carcinoma
• Stage III Renal Cell Cancer AJCC v8

• NCT number: NCT04022343
• Study type: Interventional
• Source: Emory University
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 6, 2019
• Completion date: May 25, 2025