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# Scancell Advancing iSCIB1+ Into Phase 3 Melanoma Trial
- URL: https://www.fdaweb.com/scancell-advancing-iscib1-into-phase-3-melanoma-trial/
- Published: 2026-01-26T12:00:00.000Z
- Updated: 2026-09-14T15:31:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160546

FDA has approved a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+, the company’s lead ImmunoBody immunotherapy, in patients with advanced melanoma. The agency agreed that progression-free survival could act as the surrogate primary endpoint, the company says. The late-stage trial is intended to support potential regulatory approval of iSCIB1+ in unresectable Stage IIIB/IV melanoma.

The decision follows results from Scancell’s 140-patient Phase 2 SCOPE trial, an open-label, multicenter study evaluating SCIB1 and iSCIB1+ in combination with the checkpoint inhibitors nivolumab and ipilimumab in previously untreated advanced melanoma. Based on the Phase 2 data, Scancell selected iSCIB1+ for further development and identified a biomarker-based selection strategy intended to enrich the Phase 3 population for responders, according to the company.

According to updated data from a selected cohort of the SCOPE study, progression-free survival reached 74% at 16 months in patients treated with iSCIB1+ in combination with standard checkpoint therapy. That compares with a reported 50% progression-free survival at 11.5 months for ipilimumab plus nivolumab alone, the current standard of care, based on historical and real-world data, the company says.