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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03693170 | Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer | PHASE2 | COMPLETED | 95 | — | — | Jan 17, 2019 | Apr 27, 2023 | Feb 2, 2024 | 45 | United States, Austria +7 |
The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| 1 Arm | EXPERIMENTAL | encorafenib plus binimetinib plus cetuximab |
| Name | Type | Description |
|---|---|---|
| encorafenib | DRUG | 300 mg administered orally once daily (QD) |
| Binimetinib | DRUG | Binimetinib 45 mg administered orally twice daily (BID) |
| Cetuximab | DRUG | Standard of care for the 28 first weeks(\*) and then every 2 weeks (\*\*) : (\*) 400 mg/m2 administered as a 120-min infusion on Cycle 1 Day 1, followed by 250 mg/m2 administered as a 60-min infusion once weekly (QW) for the first 28 weeks. (\*\*) 500 mg/m2 administered as a 120-min infusion twice weekly (Q2W) from Week 29 (Cycle 8 Day 1) onward. Following implementation of an Urgent Safety Measure on 26 Mar 2020 due to the outbreak of COVID-19 pandemic, cetuximab infusions could be administered Q2W regardless of the cycle number, after investigator's evaluation of the benefit/risk ratio for the subject, with regards to COVID-19 pandemic. |
Inclusion Criteria: * Male or female ≥ 18 years of age * Histologically or cytologically confirmed CRC that is metastatic * Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening * Evidence of measurable disease as per RECIST, v1.1 * Subject able to receive ...