A Phase II Study of CB-839 plus Everolimus to Treat Advanced Clear Cell Kidney Cancer

Full Title

CX-839-005: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

Purpose

Everolimus is a medication used to treat advanced kidney cancer. It works by inhibiting a protein involved in kidney cancer growth called mTOR, which can change the metabolism of the cancer. In this study, researchers are assessing the safety and effectiveness of combining everolimus with the investigational drug CB-839 in patients with advanced kidney cancer.

CB-839 is designed to stop cancer growth by blocking a protein called glutaminase, which is important for the metabolism of glutamine. Glutaminase levels are increased in some cancers and can drive the growth of cancer.

Patients in this study will be randomly assigned to receive everolimus plus CB-839 or everolimus plus a placebo (inactive drug). Both drugs are taken orally (by mouth).

Eligibility

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

  • Patients must have clear cell renal cell cancer that has continued to grow despite at least two prior regimens of therapy, one of which must have included nivolumab or cabozantinib.
  • Patients may not have previously received mTOR inhibitors.
  • Patients must recover from the serious side effects of prior treatments.
  • 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 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Chung-Han Lee at 646-422-4545.

Protocol

17-614

Phase

II

Investigator

Co-Investigators