T-VEC in Non-melanoma Skin Cancer (NCT03458117) | Clinical Trial Compass
CompletedPhase 1
T-VEC in Non-melanoma Skin Cancer
Switzerland26 participantsStarted 2018-04-19
Plain-language summary
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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)