T-VEC in Non-melanoma Skin Cancer (20139157 T-VEC)

March 17, 2022 updated by: University of Zurich

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Department of Dermatology, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline and at week 22
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)
at baseline and week 6, optionally also at week 12
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
At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Reinhard Dummer, Prof. Dr., vice-director dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Actual)

February 4, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20139157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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