Study on Sequential Treatment with Cabozantinib or Cabozantinib and Nivolumab for Advanced Kidney Cancer
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT05931393
This clinical trial is exploring the effects of a higher dose of cabozantinib alone or in combination with nivolumab for patients with advanced kidney cancer that has progressed after previous cabozantinib treatment. The study is divided into two groups based on the treatment approach.
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Program Overview
The purpose of this study is to understand how a higher dose of cabozantinib or a combination of cabozantinib and nivolumab affects patients with advanced kidney cancer (renal cell carcinoma) that has worsened after previous cabozantinib treatment. Participants will be assigned to one of two groups: one receiving a higher dose of cabozantinib alone, and the other receiving a lower dose of cabozantinib with nivolumab. The assignment will depend on how much cabozantinib the participant can safely take.
Description
This study involves two groups of patients with advanced kidney cancer that has spread or cannot be removed by surgery. The study will test the effectiveness of increasing the dose of cabozantinib or combining it with nivolumab after the cancer has progressed following cabozantinib treatment. Participants will be assigned to one of two groups based on their ability to tolerate cabozantinib. The study aims to find out if these treatments can help control the cancer better.
Eligibility Criteria
Inclusion Criteria
- Have advanced kidney cancer that has spread or cannot be removed by surgery and has worsened after cabozantinib treatment.
- Must have been on cabozantinib treatment for more than 6 months and able to tolerate it at specific doses.
- May have had previous treatment with PD-1 or PD-L1 inhibitors.
- Have measurable cancer based on specific medical criteria.
- Willing to provide a tumor sample for research purposes.
- Be 18 years or older.
- Be in good overall health with a performance status score of 2 or less.
- Able to understand and agree to the study requirements.
- Have recovered from any side effects of previous treatments.
- Have adequate organ and blood function based on specific lab tests.
- Agree to use effective birth control during and after the study if sexually active.
Exclusion Criteria
- For the group receiving cabozantinib and nivolumab, previous treatment with both drugs together is not allowed.
- Recent radiation therapy or other treatments that could interfere with the study.
- Have untreated or unstable brain cancer.
- Taking certain blood thinners or medications that could interfere with the study.
- Have uncontrolled health conditions, such as heart problems or infections.
- Have a history of significant bleeding or other serious medical issues.
- Have active autoimmune diseases or require high doses of steroids.
- Have had major surgery recently or have not fully recovered from surgery.
- Pregnant or breastfeeding women.
- Unable to swallow tablets or receive intravenous treatments.
- Have allergies to the study medications or their components.
- Have another active cancer that requires treatment.
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