Cancer Vaccine Trial Receives FDA IND Clearence in Advanced Melanoma

An investigational new drug (IND) application has been accepted by the FDA for a phase 3 trial assessing iSCIB1+, a novel cancer vaccine, for patients with advanced melanoma, according to a press release from Scancell Holdings.¹

In addition, progression-free survival (PFS) will be the surrogate end point. The phase 2 SCOPE trial (NCT04079166), which enrolled 140 patients, has been completed. The phase 2 study evaluated SCIB1 and iSCIB1+ in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy) for patients with previously untreated, unresectable stage IIIB/IV melanoma.

“This IND clearance creates a clear pathway for late stage registrational development of our iSCIB1+ Immunobody®. Data from the phase 2 SCOPE trial show a significant improvement in PFS as well as emerging overall survival [OS] with iSCIB1+ compared with historic benchmarks. I take this endorsement of our program as a strong measure of the clinical benefit and safety of our very novel product as well as the quality of our manufacturing and preclinical work,” Phil L’Huillier, PhD, MBA, chief executive officer of Scancell, said in the press release.¹

In the phase 2 trial, the PFS rate in cohort 1 was 55.6% at 23 months.² The objective response rate (ORR) was 63.4%, and the disease control rate (DCR) was 83.0%. In cohort 2, the PFS rate at 6 months was 80%, and the ORR and DCR were both 70%.

For cohort 3, the PFS rate was 77.8% at 11 months, with an ORR of 64.5% and a DCR of 80.6%. Additionally, in cohort 3, those with non-matched HLA haplotypes had a PFS rate of 45.5% at 12 months, with an ORR of 27.3% and a DCR of 54.5%.

The study highlighted that the vaccines were well-tolerated; there were no meaningful increases in adverse effects (AEs). Overall, there were 163 treatment-emergent AEs that were grade 3 or higher. A total of 30 were related to the vaccines, while 113 were related to the checkpoint inhibitors.

In the phase 2 trial, the primary end points were safety and tolerability and ORR.³ Secondary end points included duration of response, ORR by modified RECIST 1.1 criteria for immune-based therapeutics, PFS, OS, and safety and tolerability. Exploratory pre-specified end points included immune response and marker expression.

“The purpose of this study is to find out if 2 new treatment cancer vaccines called SCIB1 and iSCIB1+ can be used safely when added to nivolumab with ipilimumab, or SCIB1 with pembrolizumab [Keytruda]. Pembrolizumab or nivolumab with ipilimumab are standard treatments approved for patients with advanced melanoma,” investigators wrote on the ClinicalTrials.gov page.³ “The study will also look to see if SCIB1 or iSCIB1+ can increase the likelihood that patients with melanoma will respond to the standard treatments, and if SCIB1 and iSCIB1+ can help to make those responses last longer.”

SCIB1 or iSCRIB1+ were given up to 11 times for 85 weeks and in combination with nivolumab/ipilimumab or SCIB1 with pembrolizumab. The injection of SCIB1 or iSCIB1+ was given using the PharmaJet needle-free injection in either the upper arm or upper leg. Nivolumab/ipilimumab or pembrolizumab were given 1 week after the initial study treatment dose.

Patients were eligible for treatment if they had a histologically confirmed diagnosis of unresectable stage III or stage IV melanoma, not received prior systemic treatment for advanced disease, a known BRAF status, at least 1 measurable lesion, and HLA-positive status.

Patients were excluded from the study if they had a diagnosis of mucosal, acral, or ocular melanoma; had central nervous system disease or carcinomatous meningitis; previously received a treatment to block cytotoxic T lymphocyte-associated protein; were expected to require any other forms of systemic or localized anticancer therapy while on the study; or were taking any systemic steroid therapy within 1 week of the first study dose, or have been receiving any other form of immune suppressant medication.

References

1. Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma. News release. Sancell Holdings. January 26, 2026. Accessed January 26, 2026. https://tinyurl.com/yrptcj7c
2. Varawalla N, Shaw H, Corrie P, et al. 1325 SCOPE, an open label phase 2 parallel multi cohort clinical trial evaluating an off-the-shelf DNA plasmid vaccine in first line advanced melanoma combined with checkpoint blockade – interim read-out. J Immunother Cancer. 2025;13(suppl 3). doi:10.1136/jitc-2025-SITC2025.1325
3. SCIB1 and iSCIB1+ in melanoma patients receiving nivolumab with ipilimumab or SCIB1 with pembrolizumab (The SCOPE Study). ClinicalTrials.gov. Updated December 19, 2025. Accessed January 26, 2026. https://tinyurl.com/4dxk6vxw