Scancell Ltd
This Phase 3 clinical trial is evaluating whether adding iSCIB1+, an investigational DNA-based cancer vaccine, to standard immunotherapy with nivolumab and ipilimumab can improve outcomes for people with advanced unresectable melanoma. Participants will be randomly assigned to receive either iSCIB1+ or a placebo, in addition to standard treatment with nivolumab and ipilimumab. Neither participants nor study doctors will know which treatment has been assigned. The study will compare how long participants live without their cancer worsening, overall survival, tumor response, safety, and quality of life. iSCIB1+ is designed to stimulate the immune system to recognize and attack melanoma cells by targeting proteins commonly found on melanoma tumors. Earlier studies have shown encouraging signs of immune activation and anti-tumor activity when iSCIB1+ was combined with checkpoint inhibitor immunotherapy. This study aims to determine whether adding iSCIB1+ to standard immunotherapy provides additional benefit compared with standard immunotherapy alone
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of iSCIB1+ in combination with nivolumab and ipilimumab as first-line treatment for adults with advanced unresectable Stage III or Stage IV melanoma who express specific human leukocyte antigen (HLA) types. Checkpoint inhibitor therapy has significantly improved outcomes for patients with advanced melanoma; however, many patients still experience disease progression. iSCIB1+ is a DNA-based therapeutic cancer vaccine designed to enhance immune recognition of melanoma-associated…
5.1.Inclusion Criteria 1. Participant has histologically confirmed, unresectable Stage III or Stage IV melanoma as defined by the AJCC (Gershenwald et al., 2017). Participants with a diagnosis of melanoma of unknown primary are eligible. 2. Participant is positive for at least one of the following HLA alleles: HLA- with an HLA type of any one of HLA MHC class I: A2, A3, A31, Bw4, B44 and B35. 3. Participant has been clinically evaluated, and checkpoint inhibition has been determined to be an appropriate treatment for their advanced disease. 4. Participant's BRAF status must be known; particip…
iSCIB1+ is a DNA-based therapeutic cancer vaccine designed to enhance T-cell immune responses against melanoma-associated antigens. The vaccine encodes epitopes derived from glycoprotein 100 (gp100) and tyrosinase-related protein 2 (TRP-2) that are delivered using Scancell's ImmunoBody® platform. In this study, iSCIB1+ is administered by intramuscular injection with electroporation in combination with nivolumab and ipilimumab for the treatment of advanced unresectable melanoma. The intervention is intended to augment anti-tumor immune responses and improve clinical outcomes when added to standard checkpoint inhibitor therapy.
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor monoclonal antibody administered according to the protocol-defined treatment regimen. Ipilimumab is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) immune checkpoint inhibitor monoclonal antibody administered according to the protocol-defined treatment regimen.
The placebo is a Dulbecco's Phosphate-Buffered Saline (D-PBS) solution for intramuscular injection that contains no iSCIB1+ plasmid DNA. It is formulated to be visually and physically indistinguishable from iSCIB1+ and is administered using the same procedures to maintain study blinding. The placebo serves as the comparator in this trial when administered in combination with nivolumab and ipilimumab.