Immuno-oncology company Scancell Holdings plc (AIM: SCLP) announced on Wednesday that it has received Clinical Trial Authorization from the UK Medicines and Healthcare Products Regulatory Agency for the Phase 3 registrational trial of iSCIB1+ in patients with advanced melanoma, following U.S. Food and Drug Administration IND clearance in January 2026.

The randomized, double-blind, placebo-controlled trial will enrol 550 patients across approximately 90 sites in the US, EU, UK, Canada and Australia. Patients will receive either iSCIB1+ with ipilimumab and nivolumab or placebo with ipilimumab and nivolumab.

Scancell said the primary endpoint is progression-free survival, with overall survival as the secondary endpoint. Scancell expects the global trial to commence by the end of 2026, with initial progression-free survival data targeted for the second half of 2028.

The Phase 3 programme is supported by Phase 2 SCOPE data, in which iSCIB1+ combined with ipilimumab and nivolumab demonstrated 77% progression-free survival at 22 months in the target HLA population in first-line advanced melanoma.