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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06525220 | A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1) | PHASE3 | RECRUITING | 700 | — | — | Sep 25, 2024 | Jul 1, 2030 | Jun 2, 2026 | 205 | United States, Argentina +26 |
| NCT06496178 | A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2) | PHASE3 | RECRUITING | 600 | — | — | Jun 25, 2024 | Mar 1, 2029 | Jun 3, 2026 | 216 | United States, Argentina +22 |
| Arm | Type | Description |
|---|---|---|
| Petosemtamab + Pembrolizumab | EXPERIMENTAL | Combination Therapy |
| Pembrolizumab | ACTIVE_COMPARATOR | Monotherapy |
| MCLA-158 | EXPERIMENTAL | - |
| Investigator's Choice | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Petosemtamab | DRUG | MCLA-158 |
| Pembrolizumab | DRUG | Humanized Antibody |
| Investigator's Choice | DRUG | Cetuximab |
Inclusion Criteria: 1. Signed ICF before initiation of any study procedures 2. Age ≥ 18 years at signing of ICF 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent. 4. The eligible HNSCC primary tumor location...