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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04514484
Other study ID # NCI-2020-05956
Secondary ID NCI-2020-0595620
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 22, 2021
Est. completion date November 2, 2025

Study information

Verified date February 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.


Description:

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Study Design


Related Conditions & MeSH terms

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Intervention

Procedure:
Biospecimen Collection
Undergo blood sample collection
Drug:
Cabozantinib S-malate
Given PO
Procedure:
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Biological:
Nivolumab
Given IV

Locations

Country Name City State
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Northwestern University Chicago Illinois
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in serum markers of immune activation Change in serum markers of immune activation- immune cell subsets and cytokine levels at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Will correlate markers of immune activation and expansion of immune cell subsets and cytokines with clinical outcome. Baseline up to 16 weeks post treatment
Other Change in immune checkpoint markers Changes in immune checkpoint (PD-L1, B7x, B7-H3, HHLA2) markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Baseline up to 16 weeks post treatment
Other Change in angiogenesis markers Changes in angiogenesis markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Baseline up to 16 weeks post treatment
Other Change in infiltrating immune cell markers Changes in infiltrating immune cell markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Baseline up to 16 weeks post treatment
Primary Incidence of dose limiting toxicities (DLTs) DLTs will be defined during cycle 1 of therapy. 28 days
Secondary Immune status Will assess immune status (CD4 and CD8 cell counts). Changes in immune status at each time point from baseline will be analyzed using paired non-parametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Up to 16 weeks post treatment
Secondary Human immunodeficiency virus (HIV) viral loads Will assess HIV viral loads. Changes in viral loads at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Up to 16 weeks post treatment
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