L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)

Tumor Assessment (TA) visits will be performed at Week 8 (Day 50 from the beginning of treatment), Week 12 (Day 78), Week 16 (Day 106) and then every 8 weeks for the first year of Follow-up (FU). During second and third years of FU, TA visits will be performed every 12 Weeks. In case a response (CR, PR) or stable disease (SD) is observed, a confirmatory assessment of the tumor response will be performed 4 weeks after the TA visit, when the objective response was first recorded.

Tumor response shall be evaluated according to composite criteria, i.e. BCC-RECIST-like. Measurement of tumor lesions and documentation (photographic documentation with use of a caliper for cutaneous lesions; ultrasound for subcutaneous lesions; imaging techniques as MRI) will be performed at every TA visit.

Confirmation of response or stable disease will be assessed by histopathological analysis of specimens from the treated skin area by multiple punch biopsies. Confirmation of tumor responses will be centrally reviewed by an independent committee (Independent Central Review, ICR).

After the TA visit confirmatory of partial response or stable disease, surgery with a curative intention can be performed if considered appropriate in the judgement of the investigator and if agreed upon by the patient; in these cases, pathological response in the exeresis specimen(s) will be evaluated as described above.

Patients will be followed for overall survival (OS) after a relapse or progression, and any further treatment given will be recorded for three years. Phone contact or any other documented contact with the patient will be recorded every 6 months for OS assessment from treatment start until the death of the patient, withdrawal of consent or until study completion (LPLV).

L19IL2 or L19TNF or L19IL2/L19TNF will be administered to eligible patients under the supervision of the investigator or identified sub-investigator(s). Patients will receive intratumoral administrations of immunocytokines into injectable cutaneous, and subcutaneous tumors once weekly for up to 4 weeks.

On the day of each treatment visit, all tumors to be injected should be measured and recorded (using caliper/ruler for cutaneous lesions and/or ultrasound for subcutaneous lesions). The recommended volume to be injected into the tumor(s) is dependent on the size of the lesion(s). The maximum dose to be administered in a single treatment visit is:

i) 13 MioIU L19IL2, or ii) 0.4 mg L19TNF or iii) 13 MioIU L19IL2 + 0.4 mg L19TNF It is recommended that each lesion should receive the maximum amount possible to inject due to tumor properties at each visit.