A Phase III Study of BMS-936558 Versus Everolimus in Patients with Advanced or Metastatic Renal Cell Carcinoma Who Received Prior Anti-Angiogenic Therapy

Protocol
12-159
Full Title
A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy (Protocol CA209025)
Phase
III
Purpose

Everolimus is a drug used to treat renal cell (kidney) cancer. It works by inhibiting mTOR, a protein that drives cancer growth. Yet for many patients, the cancer continues to grow. In this study, researchers are comparing the effectiveness of the investigational drug BMS-936558 with everolimus in patients with advanced or metastatic renal cell cancer which persists despite prior treatment with anti-angiogenic therapy (drugs which inhibit the development of blood vessels cancers need to grow and spread).

BMS-936558 boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. BMS-936558 binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

Patients will be randomly assigned to receive BMS-936558 or everolimus, but not both. Everolimus is given orally (by mouth), while BMS-936558 is given intravenously (by vein).

Eligibility

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

  • Patients must have advanced or metastatic renal cell carcinoma that persists despite one or two prior regimens of anti-angiogenic therapy (such as bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, or tivozanib).
  • Patients may not have had more than three regimens of treatment for advanced disease, nor prior treatment with an mTOR or PD-1 inhibitor.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Robert Motzer at 646-422-4312.

Disease(s)
Kidney Cancer
Locations
Related Diseases