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Scancell receives UK approval to begin Phase 3 melanoma trial
Scancell receives UK approval to begin Phase 3 melanoma trial
25 August 2026
Scancell, a clinical-stage immuno-oncology company based at The Oxford Science Park, has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase 3 clinical trial of its lead cancer treatment, iSCIB1+, in patients with advanced melanoma.
The trial is an important step towards potentially bringing iSCIB1+ to patients. It is expected to involve 550 people with advanced melanoma across around 90 sites in the UK, US, Europe, Canada and Australia.
iSCIB1+ is designed to help the immune system recognise and attack cancer cells. In the Phase 3 trial, patients will receive either iSCIB1+ alongside two existing melanoma treatments, ipilimumab and nivolumab, or the two existing treatments with a placebo. Neither patients nor their doctors will know which treatment they are receiving during the trial.
The trial will initially look at how long patients can live without their cancer getting worse, with longer-term survival also being assessed. The results are intended to support applications for regulatory approval if the treatment is shown to be effective.
The UK approval follows clearance from the US Food and Drug Administration earlier this year, with regulatory submissions in Europe, Canada and Australia also underway.
Scancell expects the global Phase 3 trial to begin by the end of 2026, with initial results on progression-free survival expected in the second half of 2028.
Dr Phil L’Huillier, CEO of Scancell, said: “Our regulatory strategy continues to build momentum. The MHRA CTA for the Phase 3 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.”
The Phase 3 trial builds on encouraging results from Scancell’s earlier Phase 2 SCOPE study, which showed sustained benefits for patients receiving iSCIB1+ in combination with ipilimumab and nivolumab.
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