A Phase 2 Study of Intratumoral Administration of L19IL2/...

Primary Objective:

To evaluate the activity of intratumoral L19IL2/L19TNF in patients locally advanced cSCC progressed on or intolerant to systemic treatment.
To confirm the primary endpoint is Best Overall Response Rate (BORR) as defined by the RECIST 1.1. criteria according to an Independent Central Review (ICR).

Secondary Objectives:

To assess the safety and efficacy of L19IL2/ L19TNF.
To confirm the following secondary efficacy endpoints:
To complete Duration of Response (DoR) per RECIST 1.1 criteria according to ICR and Investigators' Assessment.
To confirm proportion of patients with pathological responses (defined as the proportion of patients with a pathological CR (no residual viable tumor "RVT"), pathological near-CR (< or = 10% RVT), or pathological PR (10% < RVT < 50%)).
To complete Progression Free Survival (PFS) according to Investigators' Assessment and ICR.
To complete Progression Free Survival (PFS) rate at 1, 2 and 3 years after the first drug administration according to Investigators' Assessment and ICR.
To complete Disease Control Rate (DCR) [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)] per RECIST 1.1 criteria according to ICR and Investigators' Assessment.
To complete Time to best tumor response (TTR) per RECIST 1.1 criteria according to Investigators' Assessment.
To complete Time to pathological complete response according to ICR and Investigators' Assessment.

Clinical Trial Details