T-VEC in Non-melanoma Skin Cancer

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03458117
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Zurich
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Reinhard Dummer, Prof. Dr.
Principal Investigator Affiliation	vice-director dermatology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Cutaneous Lymphoma, Merkel Cell Carcinoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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)

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zurich, Switzerland

Status

Recruiting

Address

Department of Dermatology, University Hospital Zurich

Zurich, , 8091

Site Contact

Reinhard Dummer, MD

Reinhard.Dummer@usz.ch

+41 44 255 25 07

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