A Pilot Study of NKTR-214 plus Nivolumab Immunotherapy in Patients with Metastatic and/or Locally Advanced Sarcoma

Full Title

A Pilot Study of NKTR-214 and Nivolumab in Selected Patients with Locally Advanced/Metastatic Sarcoma (CA209-9EM)

Purpose

Sarcoma can be challenging to treat successfully, and doctors are seeking more effective therapies. In this study, researchers are evaluating the combination of two immunotherapy drugs for patients with metastatic and locally advanced sarcoma that has continued to grow despite treatment: the investigational drug NKTR-214 and nivolumab.

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 inhibits a protein that normally puts the brakes on the immune response, enhancing the power of the immune system to find and destroy cancer cells. It is used to treat several types of cancer; its use in this study is considered investigational. 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 metastatic and/or locally advanced osteosarcoma, chondrosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (UPS/MFH), dedifferentiated/pleomorphic liposarcoma, angiosarcoma, or leiomyosarcoma that has continued to grow despite at least one prior regimen of therapy.
  • At least 3 weeks must pass since completion of prior treatments (4 weeks since antibody therapy) and entry into the study.
  • 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

17-366

Phase

Pilot

Investigator

Co-Investigators