FDA Clears Phase 3 Trial of iSCIB1+ for Advanced Melanoma Treatment

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug application from Scancell Holdings plc for a registrational phase 3 trial of iSCIB1+ immunobody in patients with advanced melanoma as of early 2026. This regulatory milestone establishes a clear pathway for late-stage development of the immunotherapy for individuals with unresectable stage 3B or 4 melanoma.

The upcoming trial will utilize progression-free survival, or the time a patient lives without their disease spreading or worsening, as the agreed surrogate endpoint to evaluate the effectiveness of the treatment in preventing the cancer from advancing.

Main data that support the findings

The transition to a phase 3 trial follows the completion of the SCOPE phase 2 study, which involved 140 patients. This trial evaluated the efficacy and durability of iSCIB1+ when used in combination with the checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab). A key outcome of the data analysis was the identification of a selection marker intended to enrich the phase 3 trial for patients most likely to respond to the therapy.

Results from the SCOPE trial specifically highlighted the performance of iSCIB1+ in cohort 3, which consisted of patients with selected human leukocyte antigen (HLA) alleles. These alleles represent approximately 80% of all patients with melanoma. In this target population, the progression-free survival rate was 74% at 16 months. This figure is notably higher than the reported progression-free survival for the current standard of care — Yervoy plus Opdivo alone — which stands at 50% at 11.5 months.

Furthermore, the data indicated that these favorable results remained consistent across several key patient subgroups, including those with low PD-L1 expression, BRAF wild-type status and individuals with prior exposure to checkpoint inhibitors. These specific groups often face more challenging outcomes with existing therapies. The study also showed emerging overall survival benefits and suggested that the treatment provides a significant improvement over historic benchmarks.

Trial details

The SCOPE trial was a phase 2, open-label, multi-center study conducted in the United Kingdom. It investigated the use of the DNA immunobody therapies SCIB1 and iSCIB1+ in combination with standard of care checkpoint inhibitors for patients with previously untreated, unresectable stage 3B/4 metastatic melanoma. The study design utilized four separate cohorts to define the parameters necessary for a randomized phase 3 registration trial.

The lead product, iSCIB1+, is an active immunotherapy designed to generate tumor-specific immunity. It is administered to patients through a needle-free intramuscular injection. The phase 2 study aimed to assess not only the efficacy of the combination but also the durability of the response. Based on these results, Scancell selected iSCIB1+ for further development in patients with specific HLA profiles. The upcoming phase 3 trial will continue to evaluate the clinical benefit of this off-the-shelf immunotherapy in a larger, registrational setting.

Safety

Data from the phase 2 SCOPE trial demonstrated that iSCIB1+ provides a safe and clinically meaningful benefit for patients with cancer. The treatment showed evidence of safety both when used as a single therapy and when administered in combination with checkpoint inhibitors.

The clearance of the investigational new drug application by the FDA serves as an endorsement of the safety profile established during the preclinical and clinical phases. This includes the validation of the manufacturing quality and the initial clinical data regarding how patients tolerate the drug. As the therapy moves into the registrational phase 3 trial, researchers will continue to monitor the safety and long-lasting immunity generated by the DNA ImmunoBody platform to ensure it remains a safe option for the 80% of melanoma patients who carry the targeted HLA alleles.

Reference

1. “Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma,” news release; https://www.globenewswire.com/news-release/2026/01/26/3225238/0/en/Scancell-announces-FDA-clearance-of-IND-application-for-global-Phase-3-trial-of-iSCIB1-in-advanced-melanoma.html

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.

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