A phase 2, three-arm, randomized study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 pembrolizumab, in stage III and IV unresectable melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors and with presence of injectable metastases

Condition studied

Patients with diagnosis of unresectable clinical stage III or IV metastatic melanoma, with presence of injectable cutaneous, subcutaneous or nodal lesions and resistant to or progressing upon anti-PD1 immunotherapy

Investigational medicinal product(s)

Eligibility

Primary endpoint

Primary endpoint of the study is the Confirmed Objective Response Rate (ORR = CR + PR) over a period of up to 2 years after first intralesional treatment, according to RECIST v1.1 criteria in each arm of the study. The primary analysis will be performed in the Intention-to-Treat population (ITT).