Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05155254 | IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) | PHASE3 | ACTIVE NOT_RECRUITING | 407 | — | — | May 17, 2022 | Sep 1, 2027 | Aug 28, 2025 | 112 | United States, Australia +14 |
PFS defined as the time from randomization to the first documented disease progression ((based on Independent Review Committee in accordance with RECIST v1.1) or death from any cause.
| Arm | Type | Description |
|---|---|---|
| IO102-IO103 + pembrolizumab | EXPERIMENTAL | IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment). Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles. |
| pembrolizumab | ACTIVE_COMPARATOR | Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). |
| Name | Type | Description |
|---|---|---|
| IO102-IO103 | DRUG | IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously |
| Pembrolizumab | DRUG | Pembrolizumab administered intravenously |
Inclusion Criteria: 1. Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy 2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unrese...