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Completed

NCT Number: NCT03458117

T-VEC in Non-melanoma Skin Cancer

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

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Key information

Conditions

Non-Melanoma Skin Cancer Adenocarcinoma Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Squamous Cell Cutaneous Lymphoma DNA Virus Infections Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Merkel Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Polyomavirus Infections Squamous Cell Carcinoma Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Dermatology, University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talimogene Laherparepvec (T-VEC)

Genetic

a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)

Primary outcomes

  1. Change from Baseline local immune effects after repeated T-VEC injections

    Time frame: 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 outcomes

  1. Detection of Tumor Regression using World Health Organization (WHO) response criteria

    Time frame: 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

  2. Systemic immune response

    Time frame: 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)

  3. Analysis of Adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Acronym: 20139157 T-VEC

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2018
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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