Philogen S.p.A.
Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objectives of this study are to evaluate efficacy, safety and pharmacokinetics of immunocytokines. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (\~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment.
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 lesion…
Inclusion Criteria: * Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. * Patients with at least one injectable and measurable cutaneous or subcutaneous lesion. * Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment. * Patients may have received prior surgery and/or radiation therapy. * Radiotherapy must have been previous…
Intratumoral injections
Intratumoral injections
Intratumoral injections