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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03458117
Other study ID # 20139157
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 19, 2018
Est. completion date March 15, 2022

Study information

Verified date March 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 15, 2022
Est. primary completion date February 4, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Genetic:
Talimogene Laherparepvec (T-VEC)
a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)

Locations

Country Name City State
Switzerland Department of Dermatology, University Hospital Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline local immune effects after repeated T-VEC injections 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) at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)
Secondary Detection of Tumor Regression using World Health Organization (WHO) response criteria Measurement of the treated tumor size will be performed at baseline and at each visit until end of the study at baseline and at week 22
Secondary Systemic immune response Detection of increased systemic immune Response markers in sera and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS) at baseline and week 6, optionally also at week 12
Secondary Analysis of Adverse events 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 At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22
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