A Phase II Study of Axitinib and Nivolumab Immunotherapy Together and Individually in Patients with TFE Kidney Cancer

Full Title

AREN1721, A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups (CIRB)

Purpose

TFE stands for “transcription factor E,” a gene and protein that activate other genes and proteins, providing multiple signals within cancer cells that can promote tumor growth. Renal cell carcinoma (RCC) is a type of kidney cancer. TFE/translocation renal cell carcinoma (tRCC) is a subtype of RCC that is more common in children and young adults, but can be found in all age groups. There is no standard treatment for this cancer.

In this study, researchers are evaluating the safety and effectiveness of axitinib and nivolumab immunotherapy together and individually in children and adults with tRCC. Both drugs are already used to treat RCC. Axitinib inhibits the growth of the blood vessels that tumors need to grow and spread; it is taken orally (by mouth). Nivolumab boosts the power of the immune system to find and destroy cancer cells; it is given intravenously (by vein).

Patients in this study will be randomly assigned to receive axitinib and nivolumab together, axitinib alone, or nivolumab alone.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed or previously treated tRCC.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 1 year and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Ortiz at 212-639-6057.

Protocol

19-129

Phase

II

Investigator

Co-Investigators