A Phase Ib/II Study of Entinostat plus Pembrolizumab Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer

Full Title

A Phase 1b/2, Open-label, Dose Escalation Study of Entinostat in Combination with Pembrolizumab in Patients with Non-small Cell Lung Cancer, with Expansion Cohorts in Patients with Non-small Cell Lung Cancer and Melanoma

Purpose

The purpose of this study is to find the highest dose of the investigational drug entinostat that can be given safely with the immunotherapy drug pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) that has continued to grow despite prior treatment.

Entinostat is thought to work in at least two ways, including (1) "epigenetic" alterations - changing the expression of particular genes that may affect the growth of cancers and their detection by the immune system, and (2) direct immune effects - blocking cells called myeloid-derived suppressor cells, which suppress the immune system's response to cancer.

Pembrolizumab is an immunotherapy medicine that 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. Pembrolizumab is already approved to treat melanoma and non-small cell lung cancer when given alone; its use in this study is considered investigational.

Combining entinostat and pembrolizumab could boost the immune system's attack on cancer cells and possibly stop or reverse tumor growth. Entinostat is taken orally (by mouth), while pembrolizumab is 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 NSCLC that continues to grow despite at least one prior therapy. Patients whose cancers contain mutated EGFR or ALK must have experienced tumor growth despite treatments that target these mutated proteins.
  • At least 2 weeks must pass between completion of prior therapies 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. Matthew Hellmann at 646-888-4863.

Protocol

15-162

Phase

I/II

Investigator

Co-Investigators

Locations