Scancell has secured MHRA clinical trial authorisation to launch a global, placebo-controlled Phase III study of its DNA ImmunoBody iSCIB1+ in advanced melanoma. The randomised, double-blind trial will enrol 550 patients across ~90 sites in Australia, Canada, the EU, the UK and the US, comparing 8 mg iSCIB1+ plus ipilimumab and nivolumab against placebo with the same checkpoint inhibitors. PFS is the primary endpoint to support an accelerated approval filing; initial PFS data are expected in H2 2028.
MHRA Greenlights Scancell's Global Phase III Trial of iSCIB1+ in Advanced Melanoma
The trial will assign patients to 8mg iSCIB1+ with ipilimumab and nivolumab or placebo plus checkpoint inhibitors. Credit: TheCorgi / Shutterstock.com.
Scancell Holdings has received clinical trial authorisation (CTA) from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with a global Phase III, registrational study of its DNA ImmunoBody candidate, iSCIB1+, in patients with advanced melanoma.
The placebo-controlled, double-blind, randomised trial will enrol 550 participants with stage III or IV unresectable melanoma at roughly 90 centres across Australia, Canada, the European Union, the United Kingdom and the United States. Participants will be randomised 1:1 to receive either 8 mg of iSCIB1+ administered alongside the checkpoint inhibitors ipilimumab and nivolumab, or a matching placebo with the same checkpoint inhibitor combination.
The study's primary endpoint is progression-free survival (PFS); overall survival (OS) is designated as a key secondary endpoint. Scancell intends to use a positive PFS outcome to support an application for accelerated approval, with OS results potentially underpinning a later submission for full regulatory approval.
The Phase III design was informed by results from the earlier Phase II SCOPE trial, in which iSCIB1+ combined with ipilimumab and nivolumab produced a sustained PFS rate of 77% at 22 months and an OS rate of 87.4% at 18 months in the targeted population.
iSCIB1+ is a DNA ImmunoBody delivered by needle-free intramuscular injection. The construct encodes an antibody directed against melanoma-associated antigens gp100 and tyrosinase-related protein 2 (TRP-2) to stimulate tumour-targeting T cell responses.
The decision to initiate the Phase III study follows clearance of an investigational new drug (IND) application by the US Food and Drug Administration in January 2026. Scancell expects to start patient enrolment by the end of 2026, with initial PFS data targeted for the second half of 2028.
Scancell CEO Dr Phil L'Huillier said: 'Our regulatory strategy continues to build momentum. The MHRA CTA for the Phase III trial of our lead asset iSCIB1+ in patients with advanced melanoma is an important milestone bringing us one step closer to delivering iSCIB1+ to patients in a global registrational trial setting.'
Important safety note: iSCIB1+ remains investigational and has not received regulatory approval for melanoma or any other indication. Its safety and efficacy have not been established by the MHRA, the FDA or other regulatory authorities.
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