Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention, including: • Basal cell carcinoma (BCC) • Cutaneous squamous cell carcinoma (cSCC) • Merkel cell carcinoma (MCC) • Keratoacanthoma (KA) • Malignant adnexal tumors of the skin (MATS) • Tumors from cutaneous T-cell lymphoma (CTCL) • Kaposi’s sarcoma (KS)
Conditions
Brief summary
• Efficacy of L19IL2/L19TNF measured as: o Confirmed best overall response rate (BORR) [Complete Response (CR) + Partial Response (PR)] for each tumor type measured according to RECIST v1.1 criteria. Confirmation of CR requires histopathological analysis of exeresis specimens for lesions removed by surgery or of biopsies in all other cases.
Detailed description
Efficacy of L19IL2/L19TNF measured as: Disease control rate (DCR) [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)] for each tumor type measured according to RECIST v1.1 criteria., Efficacy of L19IL2/L19TNF measured as: Local progression free survival (LPFS) on the treated tumors only., Efficacy of L19IL2/L19TNF measured as: Progression-free survival (PFS), assessed separately in patients who are not resected after curative intention and in patients who undergo secondary surgery (neoadjuvant intention), whatever the RECIST response to treatment, taking into account appearance of new lesions and occurrence of metastases, etc., Efficacy of L19IL2/L19TNF measured as: Among tumors not initially amenable to surgery, a proportion which are finally resected or disappear., Efficacy of L19IL2/L19TNF measured as: Effect on non-treated lesions, if any., Efficacy of L19IL2/L19TNF measured as: Pathological response for each tumor type in surgical specimens from tumors which are resected after treatment, or in biopsy for the other types., Safety of intratumoral administration of L19IL2/L19TNF.
Sponsors
Philogen S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Efficacy of L19IL2/L19TNF measured as: o Confirmed best overall response rate (BORR) [Complete Response (CR) + Partial Response (PR)] for each tumor type measured according to RECIST v1.1 criteria. Confirmation of CR requires histopathological analysis of exeresis specimens for lesions removed by surgery or of biopsies in all other cases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of L19IL2/L19TNF measured as: Disease control rate (DCR) [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)] for each tumor type measured according to RECIST v1.1 criteria., Efficacy of L19IL2/L19TNF measured as: Local progression free survival (LPFS) on the treated tumors only., Efficacy of L19IL2/L19TNF measured as: Progression-free survival (PFS), assessed separately in patients who are not resected after curative intention and in patients who undergo secondary surgery (neoadjuvant intention), whatever the RECIST response to treatment, taking into account appearance of new lesions and occurrence of metastases, etc., Efficacy of L19IL2/L19TNF measured as: Among tumors not initially amenable to surgery, a proportion which are finally resected or disappear., Efficacy of L19IL2/L19TNF measured as: Effect on non-treated lesions, if any., Efficacy of L19IL2/L19TNF measured as: Pathological response for each tumor type in surgical specimens from tumors which are | — |
Countries
France, Italy, Spain
Outcome results
None listed