A Phase II Study of Epacadostat plus Pembrolizumab Immunotherapy in Patients with Inoperable or Metastatic Sarcoma

Full Title

IIT: Phase II Study of Epacadostat in Combination with Pembrolizumab in Patients with Locally Advanced/Metastatic Sarcoma


This study is assessing the safety and effectiveness of combining pembrolizumab with the investigational drug epacadostat in patients with inoperable or metastatic sarcoma. Epacadostat and pembrolizumab are both forms of immunotherapy, but they work in different ways to stimulate the immune system to fight cancer.

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. Pembrolizumab is already approved to treat several cancers; its use in this study is considered investigational. It is given intravenously (by vein).

Epacadostat is an inhibitor of an enzyme called IDO1. Inhibition of IDO1 increases and restores the activation of the immune system, which may inhibit the growth of tumors that contain IDO1. Epacadostat is taken orally (by mouth).


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

  • Patients must have inoperable or metastatic sarcoma that continues to grow despite at least one prior regimen of standard therapy.
  • At least 2 weeks must pass between the completion of prior 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 and to inquire about eligibility for this study, please contact Dr. Sandra P. D’Angelo at 646-888-4159.