Non-melanoma Skin CancerPhase 120139157 T-VECNCT03458117
T-VEC in Non-melanoma Skin Cancer
A Phase 1 study testing Talimogene Laherparepvec (T-VEC) in people with Non-melanoma Skin Cancer and Basal Cell Carcinoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- Talimogene Laherparepvec (T-VEC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Apr 2018to 15 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital Zurich
Zurich, 8091
About this study
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
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
Read the 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.
- Conditions
- Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Cutaneous Lymphoma, Merkel Cell Carcinoma
- Being tested
- Talimogene Laherparepvec (T-VEC)
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Lymphoma, T-Cell, Cutaneous, Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talimogene Laherparepvec (T-VEC)Genetic
a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)
| Study group | Role | What they receive |
|---|---|---|
| Talimogene Laherparepvec (T-VEC) | Experimental | Intralesional injections of T-VEC up to 4.0 mL of 10 to the 6 plaque-forming Units/mL (PFU/mL) Receives: Genetic: Talimogene Laherparepvec (T-VEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)
Secondary outcomes (3)
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
Measured: at baseline and at week 22
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)
Measured: at baseline and week 6, optionally also at week 12
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
Measured: At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start19 Apr 2018
- Primary completion4 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinhard Dummer, Prof. Dr., Principal investigator, vice-director dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458117
- Sponsor's protocol ID
- 20139157
- Acronym
- 20139157 T-VEC
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2018
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03458117
- Acronym / sponsor ID
- 20139157 T-VEC / 20139157
- Conditions
- Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Cutaneous Lymphoma, Merkel Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talimogene Laherparepvec (T-VEC) | Experimental | Genetic: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Genetic | Talimogene Laherparepvec (T-VEC) |
Primary outcome
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)
3 secondary outcomes
Detection of Tumor Regression using World Health Organization (WHO) response criteria
Time frame: at baseline and at week 22
Systemic immune response
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinhard Dummer, Prof. Dr. principal investigator
vice-director dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talimogene Laherparepvec (T-VEC) in people with Non-melanoma Skin Cancer and Basal Cell Carcinoma, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.