Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brenetafusp · 2 trials · 2 indications
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. |
| Brenetafusp Monotherapy | EXPERIMENTAL | Participants receive brenetafusp. |
| Brenetafusp and Anti-PD(L)1 Agent | EXPERIMENTAL | Participants receive brenetafusp and pembrolizumab. |
| Brenetafusp and Chemotherapy | EXPERIMENTAL | Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort. |
| Brenetafusp and Targeted Therapy | EXPERIMENTAL | Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology. |
| Brenetafusp and Multimodal Therapy | EXPERIMENTAL | Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology. |
| 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. |
| Brenetafusp and pembrolizumab | DRUG | Brenetafusp and pembrolizumab IV infusions |
| Brenetafusp and chemotherapy | DRUG | Brenetafusp and chemotherapy IV infusions |
| Brenetafusp and monoclonal antibodies and chemotherapy | DRUG | Brenetafusp and a monoclonal antibody therapy and chemotherapy |
| Brenetafusp and tebentafusp | DRUG | Brenetafusp and tebentafusp IV infusions |
| Brenetafusp and bevacizumab | DRUG | Brenetafusp and bevacizumab IV infusions |
| Brenetafusp and kinase inhibitors | DRUG | Brenetafusp and oral kinase inhibitors |
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...
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