A Phase I/II Study of NKTR-255 and Cetuximab in People with Advanced Head and Neck Cancer

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Full Title

A Phase 1B/2, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-255 in Combination with Cetuximab as a Salvage Regimen for Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy NKTR-255 that can be given safely with cetuximab in people with advanced head and neck cancer that has come back or continued to grow despite treatment. Researchers will also assess the effectiveness of this treatment.

NKTR-255 may help activate the immune system to start attacking cancer cells. Giving it with cetuximab may be more effective than giving NKTR-255 on its own. Cetuximab is a standard treatment for head and neck cancer; it prevents cancer growth by stopping cancer cells from continuing to divide. Both medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic head and neck cancer that came back or continued to grow despite treatment.
  • Patients must have received prior treatment with platinum-based chemotherapy and/or immunotherapy.
  • At least 4 weeks must pass between the completion of prior treatment (2 weeks since major surgery or radiation therapy) and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Lara Dunn at 646-608-3787.

Protocol

21-293

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators