T-VEC in Non-melanoma Skin Cancer

NCT ID: NCT03458117

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2022-03-15

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Talimogene Laherparepvec (T-VEC)

Intervention Type GENETIC

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

Interventions

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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)

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reinhard Dummer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

vice-director dermatology

Locations

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Department of Dermatology, University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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20139157

Identifier Type: -

Identifier Source: org_study_id

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