L19IL2/TNF in Patients With Basal Cell Carcinoma
brief summary
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.
detailed description
Tumor Assessment (TA) visits will be performed at Week 8 (Day 50 from the beginning of treatment), Week 12 (Day 78), 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 is observed, a confirmatory assessment of the tumor response will be performed 4 weeks after the TA visit, when the response was first recorded.
Confirmation of response will be assessed by histopathological analysis of specimens from the skin treated area by multiple punch biopsies. Confirmation of tumor responses will be centrally reviewed by an independent committee (Independent Central Review, ICR).
Patients will be followed for overall survival (OS) after a relapse or progression, and any further treatment given will be recorded until LPLV. Phone contact or any other documented contact with the patient will be recorded every 6 months for OS assessment from treatment start until the death of the patient, withdrawal of consent or until study completion (LPLV).
L19IL2 or L19TNF or L19IL2/L19TNF will be administered to eligible patients under the supervision of the investigator or identified sub-investigator(s). Patients will receive intratumoral administrations of L19IL2/L19TNF into injectable cutaneous, subcutaneous tumors and nodal or in transit metastasis once weekly for up to 4 weeks. On the day of each treatment visit, all tumors to be injected should be measured and recorded (using caliper/ruler for cutaneous lesions and/or ultrasound for subcutaneous lesions). The recommended volume to be injected into the tumor(s) is dependent on the size of the lesion(s). The maximum dose to be administered in a single treatment visit is: 13 MioIU L19IL2 + 0.4 mg L19TNF. It is recommended that each lesion should receive the maximum amount possible to inject due to tumor properties at each visit.
official title
A Phase 2 Study of Intratumoral Administration of L19IL2/L19TNF in Locally Advanced Basal Cell Carcinoma Patients Progressing or Intolerant to Systemic Treatment.