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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06855212 | Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC | PHASE2 | ACTIVE NOT_RECRUITING | 22 | — | — | Feb 26, 2025 | Mar 1, 2028 | May 20, 2026 | 1 | United States |
The number of participants who achieve major or complete pathologic response rate.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Cetuximab and Cemiplimab Treatment | EXPERIMENTAL | Cemiplimab: 350 mg IV dose on C1D1 and C2D1 Cetuximab: 400mg/m2 loading dose on C1D1 followed by 250 mg/m2 IV weekly doses on C1D8, C1D15, and C2D1 (total 4 doses including the loading dose). |
| Name | Type | Description |
|---|---|---|
| Cemiplimab | DRUG | Given by IV infusion. |
| Cetuximab | DRUG | Given by IV infusion. |
Inclusion Criteria: * Must be ≥ 18 years of age at the time of consent. * Patient (or a legally authorized representative) must understand and voluntarily sign informed consent prior to any study-related assessments/procedures being conducted. * Must be able and willing to comply to the study visit...