T-VEC in Non-melanoma Skin Cancer

A Phase I, Open Label, Single Arm, Single Centre Study to Evaluate Mechanism of Action of Talimogene Laherparepvec (T-VEC) in Locally Advanced Non-melanoma Skin Cancer

Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.

This study evaluates the administration of T-VEC in non-melanoma skin cancer. The aim is to evaluate the effectiveness, safety and tolerability of T-VEC in patients with non-melanoma skin cancer through determination of local immune effects after repeated T-VEC injections.

Inclusion Criteria:

• Subjects Age ≥ 18 years
• histologically confirmed diagnosis of locally advanced squamous cell carcinoma, basal cell, carcinoma, Merkel cell carcinoma or cutaneous T cell lymphoma
• at least 1 injectable cutaneous lesion ≥ 20 mm in longest Diameter or multiple injectable lesions that in Aggregate have a longest Diameter of ≥ 50 mm
• Eastern Cooperative Oncology Group-Status (ECOG Status) 0 or 1
• Adequate organ functions

Exclusion Criteria:

• Hypersensitivity to T-VEC or any of ist components
• Presence of organ and lymph node metastases
• history or evidence of active autoimmune disease that requires systemic Treatment
• Evidence of clinically significant immunosuppression
• active herpetic skin lesions or prior complications hereof
• pregnancy, breast feeding
• requires intermittent or chronic systemic Treatment with an antiherpetic drug
• acute or chronic active Hepatitis B or C infection or HIV infection