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

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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 also 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.

In this study, researchers are assessing the safety and effectiveness of combining T-VEC with pembrolizumab in patients with locally advanced or metastatic sarcoma that persists despite prior treatment and in patients newly diagnosed with a kind of sarcoma called undifferentiated pleomorphic sarcoma/myxofibrosarcoma who are planning to have it surgically removed.

Pembrolizumab is already approved to treat several cancers; its use with T-VEC is considered investigational. 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.
  • Patients with metastatic or inoperable sarcoma must have undifferentiated pleomorphic sarcoma/myxofibrosarcoma, cutaneous angiosarcoma, or epithelioid sarcoma that has continued to grow despite prior treatment. At least 3 weeks must pass since the completion of previous therapy and entry into the study.
  • Patients receiving treatment before sarcoma surgery must have undifferentiated pleomorphic sarcoma/myxofibrosarcoma that has not yet been treated with any anticancer therapy.
  • 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. Ciara Kelly at 646-888-4312.

Protocol

16-1534

Phase

I/II

Investigator

Co-Investigators