RecruitingPhase 2Drug trial
L19IL2/TNF in Patients With Basal Cell Carcinoma
Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor board. The primary objective of the study is to evaluate the activity of intratumoral L19IL2/L19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2/L19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.