Neoplasms

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Skin and Connective Tissue Diseases

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Carcinoma, Squamous Cell

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Muir-Torre Syndrome

Neoplasms, Squamous Cell

Syndrome

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Lynch Syndrome II

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Sebaceous Gland Diseases

Skin Diseases, Genetic

Antineoplastic Agents

All Drugs and Chemicals

Talimogene laherparepvec

Antineoplastic Agents, Immunological

The subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors.

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient.

Injection of TVEC into target lesions - week 1-2

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL withapproximately 1.15 mL in a 2 mL vial for the second and subsequent doses.

Injection of TVEC into target lesions 3wks after 1st injection

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Injection of TVEC into target lesions 2wks after 2nd injection

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Injection of TVEC into target lesions 2wks after 3rd injection

Clara Curiel, MD

This is single arm a Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).

The purpose of this study is to find out more about talimogene laherparepvec (also known as OncoVEXGM-CSF or IMLYGIC®) in people with a healthy immune system with confirmed low-risk squamous cell carcinoma. Usually, low-risk SCC is treated with a surgical procedure, but surgery can be challenging when patients have: multiple SCCs on their body, when the SCC is on a challenging place on the body to remove or when patients are older or have diseases that place them at risk for surgery related complications. Immune therapy is a treatment that uses certain parts of a person's immune system to fight disease. Immune therapy is a proven therapeutic approach in many cancers, including melanoma, another type of skin cancer.

Talimogene laherparepvec (TVEC) is made from a modified herpes simplex virus type 1 (HSV-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), which multiplies and grows in tumor cells. Human GM-CSF is normally produced by various cells within the body and is used as a medicine to treat patients with white blood cell counts that are too low. This modified HSV-1 produces a protein that acts on tumor cells and stimulates the immune system. TVEC is administered by injection with a needle directly into one or more tumors and works by directly destroying cancer cells and enhancing immune response to destroy cancer cells.

Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Cutaneous Squamous Cell Cancer

The primary end point is to evaluate the overall response rate (ORR) defined as proportion of subjects who achieved complete response (CR) and partial response (PR) in the cSCC Target injected lesions (TILs).

1. Number of participants with events requiring the discontinuation of study drug

1. 75% or greater number of Target injection lesions (TILs) meeting criteria for withdrawal.
2. Identification of high-risk features in one or more TILs during study participation.
3. Persistent discomfort (consecutive weeks of lesion pain, burning, or itching of Grade 2 or more).

To measure time of response in cSCC TILs.

To measure the duration of overall response (DOR) of TILs.

Assess durable response rate (DRR) of TILs.

To measure the time to progression (TTP) of TILs

Overall response rate (ORR) (CR+PR) assessed by imaging technique (high frequency ultrasound).

Overall clinical response rate (CR+PR) of individual TILs with talimogene laherparepvec (not as overall subject response).

Overall clinical response rate (CR+PR) in cSCC Target non-injected lesion(s) (TNILs).

1. Number of safety adverse events (SAE) as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0

a. Clinically significant laboratory values i. Clinically significant laboratory values are based on participant condition and side effect. These will vary and will be determined by the clinical judgement of the research healthcare provider. Note: laboratory values will be collected for initial participant screening and side effects only, no other clinical laboratory values are scheduled in this protocol.

Local effects on the tumor as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0

1. Pain
2. Inflammation
3. Ulceration

Spots Global Cancer Trial Database for injection of tvec into target lesions 2wks after 3rd injection