Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
Study NCT ID:
NCT07227350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
Sponsor:
Philogen S.p.A.
Organization:
Study Overview
Official Title:
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 lesions and documentation (photographic documentation with use of a caliper for cutaneous lesions; ultrasound for subcutaneous lesions; imaging techniques as MRI) will be performed at every TA visit.
Confirmation of response or stable disease will be assessed by histopathological analysis of specimens from the treated skin area by multiple punch biopsies. Confirmation of tumor responses will be centrally reviewed by an independent committee (Independent Central Review, ICR).
After the TA visit confirmatory of partial response or stable disease, surgery with a curative intention can be performed if considered appropriate in the judgement of the investigator and if agreed upon by the patient; in these cases, pathological response in the exeresis specimen(s) will be evaluated as described above.
Patients will be followed for overall survival (OS) after a relapse or progression, and any further treatment given will be recorded for three years. 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 immunocytokines into injectable cutaneous, and subcutaneous tumors 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:
i) 13 MioIU L19IL2, or ii) 0.4 mg L19TNF or iii) 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.
Tumor response shall be evaluated according to composite criteria, i.e. BCC-RECIST-like. Measurement of tumor lesions and documentation (photographic documentation with use of a caliper for cutaneous lesions; ultrasound for subcutaneous lesions; imaging techniques as MRI) will be performed at every TA visit.
Confirmation of response or stable disease will be assessed by histopathological analysis of specimens from the treated skin area by multiple punch biopsies. Confirmation of tumor responses will be centrally reviewed by an independent committee (Independent Central Review, ICR).
After the TA visit confirmatory of partial response or stable disease, surgery with a curative intention can be performed if considered appropriate in the judgement of the investigator and if agreed upon by the patient; in these cases, pathological response in the exeresis specimen(s) will be evaluated as described above.
Patients will be followed for overall survival (OS) after a relapse or progression, and any further treatment given will be recorded for three years. 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 immunocytokines into injectable cutaneous, and subcutaneous tumors 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:
i) 13 MioIU L19IL2, or ii) 0.4 mg L19TNF or iii) 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-523229-16-00 | CTIS | None | View |