Phase III Study of iSCIB1+ with Ipi-Nivo as First-Line Treatment for Advanced Unresectable Melanoma
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Study of iSCIB1+ in Combination with Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma.
IRAS ID
1013573
Contact name
Joe Thornton
Contact email
Sponsor organisation
Scancell Ltd
Research summary
The purpose of this study is to find out whether adding a new vaccine immunotherapy, called iSCIB1+, to a standard treatment option makes the treatment more effective and longer lasting for people with advanced melanoma. The study plans to include about 450 people at first, and may add up to 300 more people later if needed. Participants are expected to be recruited from USA, UK, Australia and select countries within Europe.
All participants will standard treatment for advanced melanoma , which includes two immunotherapy drugs: nivolumab
and ipilimumab.In addition to the standard treatment, participants will be randomly assigned to also receive either:
- The iSCIB1+ vaccine, or
- A placebo (which does not contain any active drug)REC name
South Central - Berkshire B Research Ethics Committee
REC reference
26/SC/0117
Date of REC Opinion
9 Jun 2026
REC opinion
Further Information Favourable Opinion