Condition: Locally Advanced Basal Cell Carcinoma · Sponsor: 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. 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
This description comes directly from the study's public registry record.
Lisa Nadal · 05771526723 · lisa.nadal@philogen.com
Concetta Aulicino · +39057717816 · regulatory@philogen.com
Always discuss trial participation with your own doctor first.
| H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. | Tampa, Florida, United States | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta, Georgia, United States | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07227350