iSCIB1+ in Combination With Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor: Scancell Ltd
Study ID: NCT07815574
Phase: PHASE3
Status: Not Yet Recruiting

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Conditions

Advanced Melanoma
Melanoma (Skin Cancer)
Metastatic Melanoma
Skin Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

iSCIB1+ — BIOLOGICAL
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 & Ipilimumab — DRUG
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.
Placebo — OTHER
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.

Study Details

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

Key Dates

First listed: Sep 11, 2026
Start date: Dec 1, 2026
Status verified: Sep 2026
Primary completion: Dec 1, 2028
Completion: Dec 1, 2032

Study Design

Enrollment: 550 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: iSCIB1+ in combination with Ipilimumab and Nivolumab
Participants will receive iSCIB1+ in combination with standard immunotherapy consisting of nivolumab and ipilimumab. Treatment will be administered according to the protocol-defined dosing schedule. Following induction treatment with nivolumab and ipilimumab, participants will continue nivolumab maintenance therapy. This arm is designed to evaluate whether the addition of iSCIB1+ improves clinical outcomes compared with placebo when administered in combination with nivolumab and ipilimumab in participants with advanced unresectable melanoma.
Placebo Comparator: Placebo + Nivolumab and Ipilimumab
Participants will receive placebo in combination with standard immunotherapy consisting of nivolumab and ipilimumab. Treatment will be administered according to the protocol-defined dosing schedule. Following induction treatment with nivolumab and ipilimumab, participants will continue nivolumab maintenance therapy. This arm serves as the comparator for evaluating the efficacy and safety of iSCIB1+ when added to standard first-line immunotherapy in participants with advanced unresectable melanoma.