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.
Clinical Study Identifier: NCT02923531
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.