Last updated on February 2018

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

Contact Investigators or Research Sites near you

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Sarah Blanchette, PhD

Washington, D.C., United States

Sarah Blanchette, PhD

Boston, MA United States

Sarah Blanchette, PhD

Hackensack, NJ United States

Sarah Blanchette, PhD

Chapel Hill, NC United States

Recruitment Status: Closed

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