Back to resultsT-VEC in Non-melanoma Skin Cancer (20139157 T-VEC)
Primary Purpose
Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Talimogene Laherparepvec (T-VEC)
Sponsored by
About this trial
This is an interventional treatment trial for Non-melanoma Skin Cancer
Eligibility 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
Sites / Locations
- Department of Dermatology, University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Talimogene Laherparepvec (T-VEC)
Arm Description
Intralesional injections of T-VEC up to 4.0 mL of 10 to the 6 plaque-forming Units/mL (PFU/mL)
Outcomes
Primary Outcome Measures
Change from Baseline local immune effects after repeated T-VEC injections
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
Detection of Tumor Regression using World Health Organization (WHO) response criteria
Measurement of the treated tumor size will be performed at baseline and at each visit until end of the study
Systemic immune response
Detection of increased systemic immune Response markers in sera and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Analysis of Adverse events
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03458117
Brief Title
T-VEC in Non-melanoma Skin Cancer
Acronym
20139157 T-VEC
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Cutaneous Lymphoma, Merkel Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Talimogene Laherparepvec (T-VEC)
Arm Type
Experimental
Arm Description
Intralesional injections of T-VEC up to 4.0 mL of 10 to the 6 plaque-forming Units/mL (PFU/mL)
Intervention Type
Genetic
Intervention Name(s)
Talimogene Laherparepvec (T-VEC)
Intervention Description
a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)
Primary Outcome Measure Information:
Title
Change from Baseline local immune effects after repeated T-VEC injections
Description
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)
Time Frame
at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)
Secondary Outcome Measure Information:
Title
Detection of Tumor Regression using World Health Organization (WHO) response criteria
Description
Measurement of the treated tumor size will be performed at baseline and at each visit until end of the study
Time Frame
at baseline and at week 22
Title
Systemic immune response
Description
Detection of increased systemic immune Response markers in sera and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Time Frame
at baseline and week 6, optionally also at week 12
Title
Analysis of Adverse events
Description
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
Time Frame
At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Dummer, Prof. Dr.
Organizational Affiliation
vice-director dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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T-VEC in Non-melanoma Skin Cancer
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