Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of Concept Study
M.D. Anderson Cancer Center
Summary
The goal of our study is to explore how treatments affect the bone immune microenvironment and determine the best treatment options for patients with metastatic kidney cancer to the bone. This could prevent skeletal complications and improve patient outcomes.
Description
Primary Objectives: 1. To assess safety of obtaining biopsy within close time frame of cabozantinib treatment. 2. To evaluate the success rate of obtaining serial biopsies of bone metastases. Success is defined as viable single cell sequencing of bone biopsy samples at baseline and after 8 weeks of treatment. 3. To quantify the fold change in M1:M2 macrophage population in serial biopsies from renal cell carcinoma bone metastases. Secondary Objectives: 1. To compare the M1:M2 macrophage population at baseline and on therapy in paired bone versus non-bone metastatic sites. 2. To compare CD8+…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: To be eligible for the study, the subject must meet all of the inclusion and none of the exclusion criteria. 1. Signed Written Informed Consent 2. Ability to understand and the willingness to sign a written informed consent document. 3. Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care. 4. Participants must be willing and able to comply with scheduled…
Interventions
- DrugCabozantinib
Given by IV
- DrugNivolumab
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas