L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorPhilogen S.p.A.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin (surgically removed 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.
Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.
Current topical or systemic chemotherapy, targeted therapy immunotherapy.
Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
L19IL2
DrugIntratumoral injections
L19TNF
DrugIntratumoral injections
L19IL2/L19TNF
DrugIntratumoral injections
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: L19IL2Experimental treatment 1 intervention
Group B: L19IL2/L19TNFExperimental treatment 1 intervention
Group C: L19TNFExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Best Overall Response Rate
Confirmed Best Overall Response Rate per BCC-RECIST-like criteria according to ICR by Week 16.
Time frame
from enrollment to week 16Sponsors and contacts
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Source ClinicalTrials.gov