A Phase II Study of T-VEC Immunotherapy plus Radiation Therapy in Patients with Melanoma, Merkel Cell Cancer, and Other Solid Tumors with Skin Metastases

Full Title

A Phase II Randomized Trial of Intralesional Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) With or Without Radiotherapy for Cutaneous Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

Purpose

The purpose of this study is to evaluate the safety and effectiveness of talimogene laherparepvec (T-VEC) with or without radiation therapy in patients with melanoma, Merkel cell cancer, and other solid tumors that have spread to the skin.

T-VEC is an immunotherapy called an "oncolytic." It is injected directly into tumors that have spread to 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. Radiation therapy may cause a similar effect. Researchers are testing whether T-VEC and radiation therapy will be more effective than T-VEC by itself to stimulate the immune system to fight cancer in the body.

Patients in this study will be randomly assigned to receive T-VEC alone or with hypofractionated radiation therapy (three radiation treatments). T-VEC is approved for the treatment of advanced melanoma; its use for Merkel cell cancer and other solid tumors and in combination with radiation therapy is considered investigational.

Eligibility

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

  • Patients must have skin metastases from advanced melanoma, Merkel cell carcinoma, or another solid tumor.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Christopher Barker at 212-639-8168.

Protocol

16-224

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Diseases

Locations