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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06743126 | SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma | PHASE3 | RECRUITING | 360 | — | — | Jan 14, 2025 | Oct 1, 2031 | May 29, 2026 | 66 | United States, Canada +4 |
progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Experimental arm | EXPERIMENTAL | Non-myeloablative chemotherapy for lymphodepletion (LD) over 4 days using fludarabine (FLU) and cyclophosphamide (CY), one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy |
| Control arm- investigator's choice | ACTIVE_COMPARATOR | Investigator's choice of treatment approved by the respective Competent Authority (nivolumab plus relatlimab \[Opdualag®\], lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy \[e.g., dacarbazine, temozolomide, paclitaxel, alb-bound paclitaxel, or paclitaxel plus carboplatin\]) as determined by the site investigator in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC), optional bridging therapy. |
| Name | Type | Description |
|---|---|---|
| IMA203 | BIOLOGICAL | one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy |
| nivolumab plus relatlimab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| lifileucel | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| nivolumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| pembrolizumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| ipilimumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| Dacarbazine | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| temozolomide | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| paclitaxel | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| paclitaxel plus carboplatin | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| Albumin-Bound Paclitaxel | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
Inclusion Criteria: * Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Gro...