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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06082167 | Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | PHASE2 | ACTIVE NOT_RECRUITING | 600 | — | — | Jun 7, 2024 | Mar 1, 2029 | Aug 17, 2025 | 168 | United States, Argentina +24 |
Defined as the time from randomization to the earlier of either radiographic progressive disease (PD) per RECIST 1.1 as determined by the BICR or death from any cause
Defined as the time from randomization to death due to any cause
| Arm | Type | Description |
|---|---|---|
| Zanzalintinib + Pembrolizumab | EXPERIMENTAL | Subjects with R/M HNSCC will receive zanzalintinib + pembrolizumab |
| Zanzalintinib-Matched Placebo + Pembrolizumab | PLACEBO_COMPARATOR | Subjects with R/M HNSCC will receive zanzalintinib-matched placebo + pembrolizumab |
| Name | Type | Description |
|---|---|---|
| Zanzalintinib | DRUG | Specified doses on specified days |
| Zanzalintinib-matched Placebo | DRUG | Specified doses on specified days |
| Pembrolizumab | BIOLOGICAL | Specified doses on specified days |
Inclusion Criteria: * Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy. * Should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomizatio...