A Phase I Study Assessing Bempegaldesleukin (NKTR-214) Given with Nivolumab Immunotherapy and Axitinib in Patients with Untreated Inoperable or Metastatic Renal Cell Carcinoma

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Full Title

A Phase 1/2 Study to Evaluate the Triplet Combination of NKTR-214 plus Nivolumab and Axitinib and the Doublet Combination of Nivolumab and Axitinib in Participants with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC)

Purpose

The purpose of this study is to determine if the investigational drug bempegaldesleukin (NKTR-214) is safe when combined with nivolumab immunotherapy and axitinib as initial treatment for inoperable or metastatic renal cell carcinoma (kidney cancer). Bempegaldesleukin is a form of the protein interleukin-2 (IL-2) which has been modified in the laboratory. IL-2 is made naturally by the human immune system and serves as a messenger molecule that can help to activate immune cells, which can then kill cancer cells.

IL-2 made in the laboratory has been used to treat several forms of cancer for many years, including kidney cancer, when given in high doses. But in its original form and at the high doses that are needed, it can be quite toxic. Bempegaldesleukin is a new form of IL-2 that was designed to be safer when given to patients.

Axitinib inhibits the growth of the blood vessels that tumors need to grow and spread; it is taken orally (by mouth) as a tablet. Nivolumab boosts the power of the immune system by re-awakening immune cells that have been shut down in close vicinity of tumors; once re-activated, these immune cells can find and destroy cancer cells. Nivolumab and bempegaldesleukin are each given intravenously (by vein).

By giving the three medications together, doctors are hoping to treat kidney cancer more effectively through a simultaneous attack from multiple angles. 

Eligibility

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

  • Patients must have renal cell carcinoma with a clear cell component that is inoperable or metastatic and has not yet been treated with systemic therapies, including oral medications or immunotherapy.
  • 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 about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-888-4721.

Protocol

20-440

Phase

I/II

Investigator

Co-Investigators