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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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Brenetafusp is an investigational oncology therapy being studied for advanced melanoma and select advanced solid tumors. It is currently in Phase 3 clinical development for previously untreated advanced melanoma, and in Phase 1 for select advanced solid tumors. Brenetafusp is not yet approved by regulatory authorities.
Brenetafusp targets PRAME, a tumor-associated antigen. It is being developed as a small molecule therapy for oncology indications. The drug is designed to engage PRAME-expressing tumor cells, and its clinical trials include biomarker-selected patient populations.
Brenetafusp is being developed by Immunocore Holdings plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol IMCR. The company is conducting clinical trials of Brenetafusp in advanced melanoma and select advanced solid tumors.
Brenetafusp is in Phase 3 clinical development for advanced melanoma, based on the active PRISM-MEL-301 trial. It is also being studied in a Phase 1 trial for select advanced solid tumors. Brenetafusp is an investigational drug and has not received FDA approval.
Brenetafusp is being evaluated in two clinical trials. NCT06112314 is a Phase 3, randomized, active-controlled study of Brenetafusp versus nivolumab regimens in previously untreated advanced melanoma, with 680 participants. NCT04262466 is a Phase 1 study of Brenetafusp as a single agent and in combination with checkpoint inhibitors in select advanced solid tumors, with 410 participants.
Yes, Brenetafusp is also known as IMC-F106C. Clinical trial records use the name IMC-F106C, such as in the Phase 3 PRISM-MEL-301 trial and the Phase 1 safety and efficacy study. Both names refer to the same investigational drug being developed by Immunocore.