Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of Concept Study

NCT07187869 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: 2025-0624NCI-2025-06901
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with Cabozantinib [PO] + Nivolumab [IV] Q4W

EXPERIMENTAL

Participants standard of care treatment stage begins when the patient has completed the baseline paired core biopsies.

Drug: Cabozantinib; Drug: Nivolumab

Interventions

Cabozantinib DRUG

Given by IV

Also known as: Cometriq, Cabometyx

Treatment with Cabozantinib [PO] + Nivolumab [IV] Q4W

Nivolumab DRUG

Given by IV

Also known as: Opdivo

Treatment with Cabozantinib [PO] + Nivolumab [IV] Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Signed Written Informed Consent
• Ability to understand and the willingness to sign a written informed consent document.
• 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.
• Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and serial biopsy schedule.
• Participants must be willing to consent to PA-17-0577, a protocol led by Dr. Jianjun Gao, that allows for tissue sample collection and analysis
• Type of Participant and Target Disease Characteristics
• Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid or rhabdoid features
• Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
• No prior systemic therapy with nivolumab or cabozantinib or previous systemic treatment for metastatic disease.
• ECOG performance status ≤2 (Karnofsky ≥60%) (See Tables 1 and 2 in section 14 for reference)
• Presence of both a bone metastasis and visceral or soft tissue metastatic lesion amenable to biopsies
• Patients must have adequate organ and marrow function as defined below:
• absolute neutrophil count ≥1,000/mcL
• platelets ≥100,000/mcL
• total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Except participants with Gilbert Syndrome who must have a total bilirubin \< 3.0 x ULN)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Exelixis: collaborator

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib; Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Matthew Campbell, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Campbell, MD

CONTACT

(713) 745-5659; mcampbell3@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-09