A Phase III Study of Bempegaldesleukin (NKTR-214) Combined with Nivolumab Immunotherapy Versus Nivolumab Alone in Patients with Previously Untreated Inoperable or Metastatic Melanoma

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Full Title

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma (WIRB)

Purpose

Nivolumab immunotherapy is used to treat inoperable and metastatic melanoma, but sometimes the cancer comes back or continues to grow despite this treatment. Researchers in this study want to know if adding the investigational drug bempegaldesleukin (NKTR-214) to nivolumab is more effective than nivolumab alone in patients with previously untreated inoperable or metastatic melanoma.

Bempegaldesleukin is a modified form of a protein called interleukin-2 (IL-2) that is normally made by the immune system. This protein is designed to trigger other cells in the immune system to attack cancer cells. IL-2 has been used for certain cancers for many years. Nivolumab unleashes the power of the immune system against cancer cells by blocking a protein that normally puts the brakes on the immune response.

Patients in this study will be randomly assigned to receive bempegaldesleukin plus nivolumab or nivolumab alone. Both drugs 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 stage III or IV melanoma and may not have previously received treatment for advanced disease.
  • Patients whose cancer came back during or within 6 months of completing post-surgical treatment with nivolumab, pembrolizumab, or dabrafenib plus trametinib may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

19-362

Phase

III

Disease Status

Newly Diagnosed

Co-Investigators