A Phase II Study of Nivolumab with Ipilimumab or BMS-986016 Immunotherapy to Treat Advanced Kidney Cancer

Full Title

CA018005: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Renal Cell Carcinoma (FRACTION-RCC)

Purpose

Immunotherapies work by boosting the power of the immune system to find and kill cancer cells. Nivolumab is an immunotherapy that takes the brakes off the immune response by blocking a protein called PD-1. It is approved for treating advanced renal cell carcinoma (kidney cancer) and other cancers.

In this study, researchers are evaluating combination immunotherapy to treat patients with advanced kidney cancer. Patients will receive nivolumab plus either ipilimumab or the investigational drug BMS-986016. Ipilimumab is FDA approved to treat melanoma and has been studied in renal cell carcinoma; it works by blocking a protein called CTLA-4. BMS-986016 is designed to enhance the immune response by inhibiting a protein called LAG-3.

All of the medications used in this study are 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.
  • Patients may have previously received treatment, including immunotherapy.
  • Patients must be well enough to undergo biopsies for their disease.
  • 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

17-283

Phase

II

Investigator

Co-Investigators