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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06790966 | Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma | PHASE3 | ACTIVE NOT_RECRUITING | 252 | — | — | May 30, 2025 | Feb 1, 2029 | Apr 6, 2026 | 28 | United States |
OS is defined as the time from randomization until death from any cause.
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. PFS will be based on RECIST 1.1 as assessed by BICR.
| Arm | Type | Description |
|---|---|---|
| Interventional Arm | EXPERIMENTAL | PDS0101 + Pembrolizumab |
| Control Arm | ACTIVE_COMPARATOR | Pembrolizumab |
| Name | Type | Description |
|---|---|---|
| Combination Treatment of PDS0101 and Pembrolizumab | COMBINATION_PRODUCT | * Pembrolizumab (IV) every 3 weeks for up to 35 Cycles * PDS0101 (SC) during Cycles 1, 2, 3, 4, and 12 |
| Pembrolizumab Monotherapy | DRUG | Pembrolizumab (IV) every 3 weeks for up to 35 cycles. |
Inclusion Criteria: 1. Subject (or legally acceptable representative, if applicable) provides written informed consent for the study. 2. Subject is ≥18 years of age on the day of signing the informed consent. 3. Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and...