Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
iSCIB1 · 1 trial · 4 indications
Progression-free survival (PFS), defined as the time from randomization to the earliest occurrence of disease progression per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR) or death from any cause.
| Arm | Type | Description |
|---|---|---|
| iSCIB1+ in combination with Ipilimumab and Nivolumab | EXPERIMENTAL | 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 + Nivolumab and Ipilimumab | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ...