T-VEC in Non-melanoma Skin Cancer

Squamous Cell Carcinoma Clinical Trial

— 20139157 T-VEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458117
• Other study ID #: 20139157
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Merkel Cell
• Cutaneous Lymphoma
• Merkel Cell Carcinoma
• Non-melanoma Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma

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