Basal Cell Carcinoma, Cutaneous Lymphoma, Merkel Cell Carcinoma, Non-melanoma Skin Cancer, Squamous Cell Carcinoma
Conditions
Brief summary
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
Detailed 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.
Interventions
a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline local immune effects after repeated T-VEC injections | at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12) | Detection of increased local immune activation markers in skin biopsies of injected lesions. The following markers will be assessed by Polymerase chain reaction (PCR): interferon (IFN), 2-prime, 5-prime oligoadenylate synthetase 1 (OAS1), Interferon-induced GTP-binding protein MxA (MXA) and C-X-C motif chemokine 11 (CXCL11) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Tumor Regression using World Health Organization (WHO) response criteria | at baseline and at week 22 | Measurement of the treated tumor size will be performed at baseline and at each visit until end of the study |
| Systemic immune response | at baseline and week 6, optionally also at week 12 | Detection of increased systemic immune Response markers in sera and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS) |
| Analysis of Adverse events | At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22 | All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of T-VEC will be recorded |
Countries
Switzerland
Outcome results
None listed