A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2/L19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)
Philogen S.p.A.
Summary
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. Newly injectable lesions occurring within the 4-week treatment period of the initial target lesion will also receive multiple intratumoral administrations of immunocytokines once weekly for up to 4 weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment
Description
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…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 checkpoint inhibitors systemic treatment. * Patients may have received prior surgery and/or radiation therapy. * Radiotherapy must have been previously admini…
Interventions
- DrugL19IL2
Intratumoral injections
- DrugL19TNF
Intratumoral injections
- DrugL19IL2/L19TNF
Intratumoral injections
Locations (3)
- H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.Tampa, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- The University of Texas MD Anderson Cancer CenterHouston, Texas