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A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors (TVEC 20140318)

Clinical Trial Details

This clinical trial is for men and women diagnosed with hepatocellular carcinoma (HCC) and metastatic liver tumors (non-HCC). The purpose of this study is to find out more about talimogene laherparepvec (TVEC) in people with liver tumors that cannot be removed by surgery. The study will consist of 2 different groups of participants, those with the tumor originating in the liver and those whose tumor originated in areas outside of the liver but has spread to areas of the liver. 

This study will evaluate what doses of talimogene laherparepvec are safe for people with liver tumors to receive and whether it causes any side effects. The study will also look at the effect of talimogene laherparepvec on tumors. 

Talimogene laherparepvec is a modified form of the herpes simplex virus (HSV) type-1 (the ‘cold sore’ virus). The virus’ genes were modified in a laboratory so that it produces a protein called human granulocyte macrophage colony-stimulating factor (GM-CSF) and multiplies and grows in many different types of tumor cells. Human GM-CSF is normally produced by various cells within the body and is used as a medicine to treat people with white blood cell counts that are too low. This modified herpes simplex virus type-1 is not designed to change any of your genes, but instead acts as an agent to act on tumor cells and stimulate your immune system.

Talimogene laherpepvec has been studied in subjects with a type of cancer called melanoma.

In this study, Talimogene laherparepvec will be administered by injection with a needle directly into liver tumors with the guidance of an ultrasound or CT scan. Treatment visits will occur every 3 weeks for 15-33 weeks. It is estimated that subjects will participate in the study for approximately 32 months. Patients will continue on treatment for a total of six cycles.

Key Eligibility: 
  •  Men and women age 18 or older
  •  Diagnosis of breast cancer, colorectal cancer, gastroesophageal cancer, melanoma, non-small cell lung cancer, clear cell renal cell cancer with liver metastases or hepatocellular carcinoma (HCC) with known disease progression
  •  Non-HCC patients must have received at least 1 prior standard of care systemic anti-cancer therapy for their metastatic disease.
  •  Measurable liver tumors that are suitable for injection
  •  ECOG Performance Status of 0-1
  •  Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Alice Mercado, RN, MBA, CCRC
(646) 962-3080
alm2051@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1602017031

Sponsor:

TVEC 20140318

Status

Open to Enrollment

Age Group

Adult