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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05912244 | A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma | PHASE2 | ACTIVE NOT_RECRUITING | 43 | — | — | Jun 9, 2023 | Jun 9, 2027 | Feb 17, 2026 | 9 | United States |
will be reported as the proportion of patients who experience a complete (CR) or partial response (PR) to treatment by RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| IO102/IO103, Nivolumab, and Relatlimab | EXPERIMENTAL | All patients will be treated with nivolumab-relatlimab FDC on Day 1 of every 28-day cycle for up to two years. Patients will be treated with IO102/IO103 on Days 1 and 15 of the first two 28-day cycles, then on Day 1 of subsequent cycles for up to two total years of treatment. |
| Name | Type | Description |
|---|---|---|
| IO102/IO103 | DRUG | IO102/IO103 will be administered subcutaneously on Days 1 and 15 of the first two 28-day cycles, and then on Day 1 only of subsequent cycles for two total years of treatment. Each vaccine contains 85ug. |
| Nivolumab-Relatlimab | DRUG | Nivolumab-relatlimab will be administered as a single infusion 160mg relatlimab and nivolumab 480 mg for all participants. Both agents will be combined in a single fixed-dose combination (FDC) as an intravenous 30-minute infusion every four weeks. |
Inclusion Criteria: 1. Age ≥ 18 years at the time of informed consent 2. Patient must be able to provide informed consent. 3. Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy. 4. Patient m...