Status:
COMPLETED
T-VEC in Non-melanoma Skin Cancer
Lead Sponsor:
University of Zurich
Conditions:
Non-melanoma Skin Cancer
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 throu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03458117
Start Date
April 19 2018
End Date
March 15 2022
Last Update
March 18 2022
Active Locations (1)
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1
Department of Dermatology, University Hospital Zurich
Zurich, Switzerland, 8091