A Pilot Study of ONCOS-102 Followed by Pembrolizumab Immunotherapy in Patients with Melanoma that Has Grown after Pembrolizumab or Nivolumab

Full Title

A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GM-CSF, and Pembrolizumab in Patients with Advanced or Unresectable Melanoma Progressing after PD1 Blockade

Purpose

Pembrolizumab and nivolumab are immunotherapy drugs that boost the ability of the immune system to detect and kill cancer cells. They are both used to treat melanoma, but often the tumor stops responding to them and continues to grow. This may happen because the tumor finds a way to stop the attack by immune cells. One way to “wake up” immune cells already inside a tumor is to inject a modified virus directly into the tumor.

ONCOS-102 is an investigational drug that is a modified version of adenovirus, one of the viruses that causes the common cold. It has been found to be safe in patients with cancer and is given with a low dose of the anticancer drug cyclophosphamide, to reduce levels of certain immune cells that may be protecting the tumor. In this study, researchers are assessing ONCOS-102 and cyclophosphamide followed by pembrolizumab in patients with melanoma that has continued to grow despite prior pembrolizumab or nivolumab immunotherapy. It is hoped that this investigational treatment will restart the immune attack on melanoma cells.

Pembrolizumab and cyclophosphamide are given intravenously (by vein), and ONCOS-102 is given by injection into the tumor.

Eligibility

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

  • Patients must have melanoma that has continued to grow despite prior pembrolizumab or nivolumab immunotherapy.
  • 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. Alexander Shoushtari at 646-888-4161.

Protocol

16-1107

Phase

Pilot

Co-Investigators

Diseases