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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07529873 | Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma | PHASE2 | NOT YET_RECRUITING | 131 | — | — | May 1, 2026 | Dec 1, 2030 | Apr 14, 2026 | - | — |
the objective response rate (ORR) which is defined as the proportion of patients with a confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by the investigator according to RECIST criteria 1.1.
| Arm | Type | Description |
|---|---|---|
| Ficerafusp + nivolumab | EXPERIMENTAL | Combination of Ficerafusp alfa + Nivolumab * Ficerafusp alfa 1500 mg every week * Nivolumab 240 mg every 2 weeks |
| Nivolumab | ACTIVE_COMPARATOR | Nivolumab monotherapy • Nivolumab 240 mg every 2 weeks |
| Name | Type | Description |
|---|---|---|
| Ficerafusp alfa | DRUG | Ficerafusp alfais a bifunctional recombinant fusion protein consisting of a chimeric anti-EGFR mAb and human TGFβRII-ECD |
| Nivolumab | DRUG | Nivolumab is a monoclonal antibody that binds to and blocks the programmed cell death 1 receptor. It is used to treat certain cancers. |
Inclusion Criteria: * Patient or legally authorized representative, if applicable, has signed and dated informed consent form (ICF) indicating that the patient (or legally authorized representative, if applicable) has been informed of all the pertinent aspects of the study prior to enrollment and t...