A Phase I/II Study of NKTR-214 plus Nivolumab Immunotherapy to Treat Advanced Solid Tumors

Full Title

16-214-02: A Phase 1/2, Open-Label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Ipilimumab in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies

Purpose

The purpose of this study is to assess the safety and preliminary effectiveness of combination immunotherapy with the investigational drug NKTR-214 plus nivolumab in patients with metastatic solid tumors, including melanoma, renal cell carcinoma (kidney cancer), non-small cell lung cancer, bladder cancer, and triple-negative breast cancer. NKTR-214 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.

Nivolumab also boosts the power of the immune system to detect and destroy cancer cells. It works by blocking 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 mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab is approved for the treatment of several types of cancer; its use in this study with NKTR-214 is considered investigational.

Both NKTR-214 and nivolumab 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 inoperable or metastatic melanoma, renal cell carcinoma, non-small cell lung cancer, bladder cancer, or triple-negative breast cancer.
  • Patients must recover from the serious side effects of prior therapies before entering the study. In addition, there are specific criteria limiting the number of previous chemotherapy regimens for each tumor type.
  • Patients may not have received prior IL-2 therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Sandra P. D’Angelo at 646-888-4159.

Protocol

17-483

Phase

I/II

Investigator

Co-Investigators