A Phase I Study of Nivolumab in Combination with Sunitinib, Pazopanib, or Ipilimumab in Patients with Metastatic Renal Cell Carcinoma

Full Title
A Phase I Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib, or Ipilimumab in Subjects with Metastatic Renal Cell Carcinoma

Nivolumab 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. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

In this clinical trial, nivolumab is being paired with other medications to enhance its anticancer effect. The purpose of this study is to find the highest dose of nivolumab that can be given safely in combination with one of three medications — sunitinib, pazopanib, or ipilimumab — in patients with metastatic renal cell carcinoma.

The parts of the study pairing nivolumab with sunitinib or pazopanib have now been closed to enrollment. All patients being considered for study participation at this point would be treated with a combination of nivolumab and ipilimumab. Ipilimumab and nivolumab are approved for treating melanoma; their use for treating renal cell carcinoma is considered investigational. Similar to nivolumab, ipilimumab works by triggering an immune response against cancer.

Nivolumab and ipilimumab are given intravenously (by vein).


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 not have had prior therapy with a systemic anticancer medication for their kidney cancer. Exceptions include patients previously treated with cytokine therapy (such as interferon or interleukin-2) and those previously treated on a clinical trial administering medication following the surgical removal of a kidney mass with no evidence of metastatic disease (a so-called “adjuvant” study).
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-422-4631.

Kidney Cancer
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