Last updated on July 2017

Addition of X4P-001 to Nivolumab Treatment in Patients With Renal Cell Carcinoma


Brief description of study

The purpose of this study is to determine if the combination of X4P-001 plus nivolumab is safe and tolerable. Secondly, the study will investigate if adding X4P-001 to nivolumab treatment has an effect on the body and the cancer tumor, in patients receiving nivolumab but not exhibiting a radiological response.

Detailed Study Description

Treatment with immune checkpoint inhibitors, such as nivolumab, may result in the generation of anti-tumor immune responses. However, the objective radiological response in advanced RCC patients was only 21.5%. Therefore, it is important to identify additional therapies that could augment the anti-tumor immune activity of checkpoint inhibitors, resulting in an increase in the number of patients able to achieve a radiological response to treatment. While checkpoint inhibitors facilitate activation of cytotoxic T cells, the agents do not impact T cell trafficking. X4P-001, a CXCR4 antagonist, is hypothesized to impact the trafficking of immune cell types, for example, decreasing myeloid-derived suppressor cells and increasing cytotoxic T cells at the tumor. Giving X4P-001 treatment in combination with nivolumab is hypothesized to increase the clinical response to by providing an influx of T cells that can be further activated by the checkpoint inhibitor. Additionally, CXCR4 plays a role in trafficking of endothelial progenitor cells which mediate angiogenesis. RCC is known to be responsive to anti-angiogenic agents, and thus X4P-001 targets a second mechanism of tumor growth inhibition.

Clinical Study Identifier: NCT02923531

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Sarah Blanchette, PhD

Washington, D.C., United States
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Sarah Blanchette, PhD

Boston, MA United States
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Sarah Blanchette, PhD

Hackensack, NJ United States
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Sarah Blanchette, PhD

Chapel Hill, NC United States
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