T-VEC in Non-melanoma Skin Cancer

Phase 1

Completed

• Conditions: Basal Cell Carcinoma; Merkel Cell Carcinoma; Non-melanoma Skin Cancer; Squamous Cell Carcinoma; Cutaneous Lymphoma
• Interventions: Genetic: Talimogene Laherparepvec (T-VEC)

• Registration Number: NCT03458117
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-08
• Study Start: 2018-04-19
• Primary Completion: 2022-02-04
• Status Verified: 2022-03
• Study Completion: 2022-03-15
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Talimogene Laherparepvec (T-VEC)	Talimogene Laherparepvec (T-VEC)	Intralesional injections of T-VEC up to 4.0 mL of 10 to the 6 plaque-forming Units/mL (PFU/mL)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Department of Dermatology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland