T-VEC in Non-melanoma Skin Cancer (20139157 T-VEC)

University of Zurich (UZH)

Status and phase

Completed

Phase 1

Conditions

Squamous Cell Carcinoma

Non-melanoma Skin Cancer

Cutaneous Lymphoma

Merkel Cell Carcinoma

Basal Cell Carcinoma

Treatments

Genetic: Talimogene Laherparepvec (T-VEC)

Study type

Interventional

Funder types

Other

Identifiers

NCT03458117

20139157

Details and patient eligibility

About

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

Full description

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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