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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06727565 | Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 | PHASE2 | ACTIVE NOT_RECRUITING | 100 | — | — | Feb 18, 2025 | Aug 1, 2026 | Mar 2, 2026 | 23 | United States, Australia +7 |
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using investigator assessments.
PFS is defined as the time from the date of randomization until the first date of documented progressive disease (PD) or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy | EXPERIMENTAL | Participants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). |
| Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy | EXPERIMENTAL | Participants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). |
| Name | Type | Description |
|---|---|---|
| Domvanalimab | DRUG | Administered intravenously |
| Zimberelimab | DRUG | Administered intravenously |
| Paclitaxel | DRUG | Administered intravenously |
| Carboplatin | DRUG | Administered intravenously |
Key Inclusion Criteria: * Histologically or cytologically confirmed r/m squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. * No prior systemic therapy for r/m HNSCC. Individuals who had disease progression or recurrence m...