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

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ClinicalTrials.gov Identifier: NCT03458117
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-melanoma Skin Cancer Basal Cell Carcinoma Squamous Cell Carcinoma Cutaneous Lymphoma Merkel Cell Carcinoma Genetic: Talimogene Laherparepvec (T-VEC) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020


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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458117


Contacts
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Contact: Reinhard Dummer, Prof. Dr. +41 44 255 25 07 reinhard.dummer@usz.ch
Contact: Emmanuella Guenova-Hötzenecker, PD Dr. +41 44 255 25 07 emmanuella.guenova@usz.ch

Locations
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Switzerland
Department of Dermatology, University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Reinhard Dummer, MD       Reinhard.Dummer@usz.ch   
Principal Investigator: Simone M Goldinger, MD         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Reinhard Dummer, Prof. Dr. vice-director dermatology

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03458117     History of Changes
Other Study ID Numbers: 20139157
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Talimogene laherparepvec
Antineoplastic Agents, Immunological
Antineoplastic Agents