A Phase I/II Study to Find the Best Dose of NKTR-262 in Combination with NKTR-214, with or without Nivolumab Immunotherapy, in Patients with Inoperable and Metastatic Cancers

Full Title

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination with NKTR-214 and in Combination with NKTR-214 plus Nivolumab in Patients with Locally Advanced or Metastatic Solid Tumor Malignancies

Purpose

The purpose of this study is to find the best dose of the investigational drug NKTR-262 when given in combination with another investigational drug, NKTR-214, with and without nivolumab immunotherapy in patients with inoperable and metastatic solid tumors. NKTR-214 is a modified form of a protein called interleukin-2 (IL-2) that is normally made by the immune system. NKTR-262 is another immunotherapy drug that is meant to increase the process by which the body recognizes the cancer as foreign. Both drugs are designed to trigger different cells in the immune system to attack cancer cells.

Nivolumab is another form of immunotherapy and is already used to treat a variety of cancers. It 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.

Patients in this study will receive various dosing combinations of NKTR-262 and NKTR-214. Some patients will also receive nivolumab. NKTR-262 is injected directly into a tumor. NKTR-214 and nivolumab are each 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, Merkel cell carcinoma, triple-negative breast cancer, ovarian cancer, renal cell (kidney) cancer, colorectal cancer, urothelial cancer, or sarcoma that cannot be successfully treated with existing therapies.
  • Patients must recover from the serious side effects of prior treatments before entering 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

18-360

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator