A Phase I/IB Study of Pembrolizumab Immunotherapy plus Guadecitabine and Mocetinostat in Patients with Advanced Non-Small Cell Lung Cancer

Full Title

An Open-label, Phase I/Ib Study of Combined Pembrolizumab plus Guadecitabine and Mocetinostat for Patients with Advanced NSCLC

Purpose

The purpose of this study is to find the best dose of the investigational drugs guadecitabine and mocetinostat to be given safely and effectively with pembrolizumab immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC). Pembrolizumab is already used to treat NSCLC; its use in combination with guadecitabine and mocetinostat is considered investigational.

Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Guadecitabine and mocetinostat are “epigenetic therapies” that work on certain genes that may be turned on or off in cancer. They may enhance the body’s immune response to cancer.

Pembrolizumab is given intravenously (by vein). Guadecitabine is given by subcutaneous (under the skin) injection, and mocetinostat is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIB or IV NSCLC.
  • Patients may not have previously received PD-1 immunotherapy.
  • Patients may not have received more than one prior regimen of therapy for advanced disease.
  • At least 3 weeks must pass between the completion of prior treatment and entry into the study.
  • Patients with NSCLC containing EGFR or ALK mutations are not able to participate, since there are other therapies available that target those cancers.
  • 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 and to inquire about eligibility for this study, please contact Dr. Matthew Hellmann at 646-888-4863.

Protocol

17-241

Phase

I

Investigator

Co-Investigators