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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06246149 | Adjuvant Tebentafusp in High Risk Ocular Melanoma | PHASE3 | RECRUITING | 290 | — | — | Nov 11, 2024 | Nov 1, 2032 | Mar 4, 2026 | 14 | Belgium, France +6 |
| NCT06070012 | Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma | PHASE2 | RECRUITING | 44 | — | — | Aug 18, 2025 | Sep 30, 2030 | Feb 27, 2026 | 3 | United States |
RFS is defined as the time between randomization and local recurrence, distant recurrence, or death, whichever occurs first
ctDNA response (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured using Signatera assay.
| Arm | Type | Description |
|---|---|---|
| Tebentafusp | EXPERIMENTAL | Participants will receive tebentafusp 20 mcg on week 1, 30 mcg on week 2, 68 mcg on week 3, and 68 mcg weekly thereafter for 6 months i.e., maximum 26 infusions. |
| Observation | NO_INTERVENTION | - |
| Tebentafusp (IMCgp100) | EXPERIMENTAL | Dose: 20mcg W1D; 30mcg W2D1; 68mcg W3D1and subsequent doses Frequency: Weekly on D1 of 12-week cycles |
| Name | Type | Description |
|---|---|---|
| Tebentafusp | DRUG | Tebentafusp will be administered weekly i.v. |
Inclusion Criteria: * Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy * Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks ) * High-risk according to eith...