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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06887088 | Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases | PHASE2 | RECRUITING | 33 | — | — | May 29, 2025 | Jan 1, 2028 | Oct 1, 2025 | 18 | Spain |
Contrast enhanced brain MRI and/or color digital photography will be performed baseline and every 8 weeks (+/-1 week) up to 12 months and according to standard practice thereafter until disease progression, independently of the end of treatment (except for documentation of disease progression).
| Arm | Type | Description |
|---|---|---|
| Encorafenib+biNimetinib followed Cemiplimab+Fianlimab in BRAF mutated melanoma and brain metastses | EXPERIMENTAL | Patients with BRAF mutant melanoma and symptomatic brain metastases will treatment with encorafenib plus binimetinib followed by cemiplimab and fianlimab Induction treatment with oral encorafenib 450 mg once daily (QD) + binimetinib 45 mg twice daily (BID)(combination: EB) for approximately two months (i.e. 8 weeks) followed by cemiplimab 350 mg + fianlimab 1600 mg combination every 3 weeks (Q3W)(Combination: CF) administered to patients intravenously (IV) for up to two years. Treatment may be discontinued due to death, PD or non-acceptable toxicity. Encorafenib plus binimetinib should be discontinued at least 72 hours prior to the first dose of cemiplimab plus fianlimab. Rechallenge with encorafenib 450mg QD + binimetinib 45 mg BID will be mandatory for those patients that progress under CF, with the exception of patients with intracranial response or stabilization and only extracranial PD in which case CF could be continued at the physician criteria. In the case of continuing treat |
| Name | Type | Description |
|---|---|---|
| Encorafenib + Binimetinib | DRUG | Induction treatment with oral encorafenib 450 mg once daily (QD) + binimetinib 45 mg twice daily (BID)(combination: EB) for approximately two months (i.e. 8 weeks) |
| cemiplimab+fianlimab | DRUG | cemiplimab 350 mg + fianlimab 1600 mg combination every 3 weeks (Q3W)(Combination: CF) administered to patients intravenously (IV) for up to two years. |
Inclusion Criteria: Patients eligible for inclusion in this study must meet all the following criteria: * Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities. * Histologically confirmed diagnosis of unresectable metastatic B...