A Phase III Study of Immunotherapy with Pembrolizumab Alone and with T-VEC in Patients with Stage III or IV Melanoma

Full Title

A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma

Purpose

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 melanoma as well as non-small cell lung cancer. It is given intravenously (by vein).

T-VEC (talimogene laherparepvec) is another form of immunotherapy used to treat melanoma. It is a virus-based therapy that stimulates an immune response against melanoma cells after being injected into a tumor.

In this study, researchers are comparing the effectiveness of pembrolizumab alone and in combination with T-VEC in patients with stage III or IV melanoma. Patients will receive pembrolizumab and T-VEC or pembrolizumab and a placebo.

Eligibility

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

  • Patients must have inoperable stage III or stage IV melanoma of the skin.
  • At least 4 weeks must pass between completion of prior treatment 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. Charlotte Ariyan at 212-639-6280.

Protocol

16-496

Phase

III

Investigator

Diseases

Locations