A Phase IB/II Study of Immunotherapy with T-VEC plus Pembrolizumab to Treat Primary Liver Tumors and Liver Metastases

Full Title

A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors Alone and in Combination With Systemic Pembrolizumab

Purpose

In this study, researchers are assessing the safety and effectiveness of combining talimogene laherparepvec (T-VEC) with pembrolizumab immunotherapy in patients with inoperable primary liver cancer or liver metastases. Combining immunotherapy drugs may have a greater effect against cancer than using them individually.

T-VEC is called an “oncolytic virus.” It is injected directly into tumors, 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. T-VEC is currently approved to treat melanoma; its use in this study is investigational.

Pembrolizumab 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 also considered investigational.

T-VEC will be injected directly into liver tumors, and pembrolizumab will be 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 hepatocellular carcinoma or liver metastases from another cancer.
  • At least 4 weeks must pass since the completion of prior local liver therapies, immunotherapy, or liver surgery; 3 weeks since chemotherapy; and 2 weeks since targeted therapy or hormonal 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. Joseph Erinjeri at 212-639- 3363.

Protocol

18-095

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators