A Phase II Study of T-VEC plus Pembrolizumab Immunotherapy in Patients with Sarcoma

Full Title

A Phase II Study of Talimogene Laherparepvec (T-VEC) Administered Concurrently with the Anti-PD1 Monoclonal Antibody Pembrolizumab in Patients with Metastatic and/or Locally Advanced Sarcoma

Purpose

Talimogene laherparepvec (T-VEC) is an immunotherapy called an “oncolytic.” It is injected directly into tumors in the skin, where it reproduces inside cancer cells and causes the cells to rupture and die. In some patients, this stimulates the immune system to fight the cancer throughout the body.

Pembrolizumab is a form of immunotherapy. It 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.

In this study, researchers are assessing the safety and effectiveness of combining T-VEC with pembrolizumab in patients with locally advanced or metastatic sarcoma. Combining immunotherapy drugs may have a greater effect against cancer than using them individually. T-VEC is injected directly into a tumor, and 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 sarcoma that is accessible for injection and has continued to grow despite prior treatment.
  • At least 4 weeks must pass since the completion of previous 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 about this study and to inquire about eligibility, please contact Dr. Sandra P. D’Angelo at 646-888-4159.

Protocol

16-1534

Phase

I/II

Investigator

Co-Investigators