Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT07187869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of Concept Study
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of Concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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+, Granzyme+ cells on multiplex immunofluorescence at baseline and on therapy in paired bone versus non-bone metastatic sites.
3. To describe serum marker changes over time while on therapy for bone metastasis including bone alkaline phosphatase, osteopontin, procollagen type I amino-terminal propeptide (PINP), and beta-isomer of carboxy-terminal telopeptide of type I collagen (รข-CTX) and association with response and progression.
4. To describe overall response rate (proportion of participants who achieve a best response of complete response or partial response using RECIST 1.1 criteria), time until progression (time from initiation of systemic treatment to the date of documented disease progression), and progression-free survival (time between the first date of systemic treatment to first date of documented progression or death due to any cause).
5. To describe incidence of skeletal related events defined as a composite of pathologic fracture, spinal cord compression, radiation or surgery to bone, and hypercalcemia of malignancy.
2.3 Exploratory Objective:
1\. OPTIONAL: To describe findings in Extreme CT scan at baseline and/or at 6 months and association with skeletal related events.
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+, Granzyme+ cells on multiplex immunofluorescence at baseline and on therapy in paired bone versus non-bone metastatic sites.
3. To describe serum marker changes over time while on therapy for bone metastasis including bone alkaline phosphatase, osteopontin, procollagen type I amino-terminal propeptide (PINP), and beta-isomer of carboxy-terminal telopeptide of type I collagen (รข-CTX) and association with response and progression.
4. To describe overall response rate (proportion of participants who achieve a best response of complete response or partial response using RECIST 1.1 criteria), time until progression (time from initiation of systemic treatment to the date of documented disease progression), and progression-free survival (time between the first date of systemic treatment to first date of documented progression or death due to any cause).
5. To describe incidence of skeletal related events defined as a composite of pathologic fracture, spinal cord compression, radiation or surgery to bone, and hypercalcemia of malignancy.
2.3 Exploratory Objective:
1\. OPTIONAL: To describe findings in Extreme CT scan at baseline and/or at 6 months and association with skeletal related events.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-06901 | OTHER | NCI-CTRP Clinical Trials Registry | View |