Primary Objective~To evaluate the tumour responses of both injected and non injected tumours following treatment with intratumoural injections of tigilanol tiglate into one or more tumours (according to RECIST v1.1); and~To assess the tumour ablation rate following treatments with intratumoural injections of tigilanol tiglate.~Secondary Objectives~To assess the tumour recurrence rate at injected tumour site(s);~To assess the safety and tolerability of intratumoural injections of tigilanol tiglate;~To assess the degree of wound healing at injection sites; and~To evaluate disease control by looking at Progression Free Survival (PFS) in melanoma participants receiving tigilanol tiglate injections over 36 months.~Exploratory Objectives~To evaluate Overall Survival (OS) in melanoma participants receiving tigilanol tiglate injections over 36 months;~To assess the tumour microenvironment by looking at the degree of immune cell infiltration in non-injected tumours; and~To assess the Quality of Life (QoL) in melanoma participants receiving tigilanol tiglate injections.
A phase IIb, multicentre, open label study to evaluate the effectiveness, safety, and tolerability of intratumoural tigilanol tiglate in adult participants with Stage IIIB to IV M1c melanoma