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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1b/2a Trial Adding X4P-001 in Patients Receiving Nivolumab for Treatment of Advanced Clear Cell Renal Cell Carcinoma

Brief Summary: 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 Summary:

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.


Sponsor: X4 Pharmaceuticals

Current Primary Outcome: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum Plasma Concentration (Cmax) [ Time Frame: Up to 8 hrs post-dose ]
  • Area Under the Curve (AUC) [ Time Frame: Up to 8 hrs post-dose ]
  • Minimum Plasma Concentration (Cmin) [ Time Frame: Up to 8 weeks ]
  • Objective Response Rate [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  • Duration of Objective Response [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  • Time to Objective Response [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  • Disease Control Rate [ Time Frame: 16 weeks and 24 weeks ]
  • Progression Free Survival [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
  • Time to Progression [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]


Original Secondary Outcome: Same as current

Information By: X4 Pharmaceuticals

Dates:
Date Received: September 30, 2016
Date Started: September 2016
Date Completion: February 2018
Last Updated: February 8, 2017
Last Verified: February 2017