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Clinical Trial Summary

The goal of this clinical trial is to learn about the effects of a higher dose of cabozantinib or the effects of cabozantinib-nivolumab combination in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment. The study will have two parts or "cohorts". - Cohort 1: cabozantinib 80mg daily - Cohort 2: cabozantinib 40mg daily with nivolumab The cohort assignment will be determined by investigator, based on how much cabozantinib the participant is able to safely receive.


Clinical Trial Description

This is a multi-center, open-label, 2 cohort, phase II study to assess the efficacy of cabozantinib dose escalation and cabozantinib/nivolumab combination at the time of progression on/after cabozantinib monotherapy. The study will enroll subjects with advanced RCC (defined as locally advanced, unresectable or metastatic) who have disease progression on/after cabozantinib monotherapy in any line of treatment ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05931393
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact Amy Rowell, MBA,CCRP
Phone 214-648-7097
Email amy.rowell@utsouthwestern.edu
Status Recruiting
Phase Phase 2
Start date December 20, 2023
Completion date December 31, 2027

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