Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMA203 · 2 trials · 3 indications
progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1
Number of DLTs will be used to determine the maximum tolerated dose (MTD) and/or recommended dose for extension (RDE) after treatment with IMA203 product in combination with mRNA-4203
Used to evaluate safety and tolerability of treatment with IMA203 in combination with mRNA-4203
| 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. |
| IMA203 with mRNA-4203 in participants with metastatic cutaneous melanoma or synovial sarcoma | EXPERIMENTAL | This is a non-comparative, open-label trial with different cohorts investigating IMA203 in combination with mRNA-4203. |
| 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) |
| mRNA-4203 | BIOLOGICAL | mRNA-4203 will be administered starting on Day 15 after IMA203 infusion at the earliest. mRNA-4203 will be given for 12 cycles (28 day cycle length); during Cycle 1 it will be given on Day 1 and Day 15 and in Cycles 2-12 it will be given on Day 1. |
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...