Clinical trial · Interventional
T-VEC in Non-melanoma Skin Cancer
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
NCT03458117CI-TRIAL-0005722920139157 T-VECcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Cutaneous Lymphoma | Cutaneous Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-melanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Talimogene Laherparepvec (T-VEC) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Talimogene Laherparepvec (T-VEC)
- description
- Intralesional injections of T-VEC up to 4.0 mL of 10 to the 6 plaque-forming Units/mL (PFU/mL)
- interventionNames
- Genetic: Talimogene Laherparepvec (T-VEC)
Primary outcomes (1)
- measure
- Change from Baseline local immune effects after repeated T-VEC injections
- timeFrame
- at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)
- 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)
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.