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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06112314 | IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) | PHASE3 | RECRUITING | 680 | — | — | Jun 5, 2024 | Oct 16, 2027 | Feb 25, 2026 | 211 | United States, Argentina +24 |
PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
| Arm | Type | Description |
|---|---|---|
| Arm A: Brenetafusp Low Dose + Nivolumab | EXPERIMENTAL | Participants receive brenetafusp Low Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W. Closed to randomization after dose recommendation by the IDMC in November 2025. |
| Arm B: Brenetafusp High Dose + Nivolumab | EXPERIMENTAL | Participants receive brenetafusp High Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W. Selected as go-forward experimental arm after dose recommendation by the IDMC in November 2025 |
| Arm C: Nivolumab OR Nivolumab + Relatlimab | ACTIVE_COMPARATOR | Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W. |
| Name | Type | Description |
|---|---|---|
| Brenetafusp | DRUG | Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL. |
| Nivolumab | DRUG | Concentrate for solution for infusion at a unit dose of 10 mg/mL. |
| Nivolumab + Relatlimab | DRUG | Concentrate for solution for infusion at a unit dose of 16 mg/mL. |
Inclusion Criteria: * Participants must be HLA-A\*02:01-positive * Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma * Archived or fresh tumor tissue sample that must be confirmed as adequate * Participants must have measurable disease per RECIST 1.1 * Part...