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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cabozantinib

    Drug

    Given by IV

  • Nivolumab

    Drug

    Given by IV

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Treatment with Cabozantinib [PO] + Nivolumab [IV] Q4WExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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