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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04260126 | Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC | PHASE2 | COMPLETED | 95 | — | — | Mar 29, 2021 | May 14, 2025 | Oct 1, 2025 | 23 | United States, Ireland +2 |
RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab and PDS0101 | EXPERIMENTAL | Pembrolizumab will be administered via IV Infusion followed by subcutaneous injections of PDS0101 five times throughout the course of the study. Pembrolizumab monotherapy will be administered every cycle there is not a combination treatment until disease progression or up to Cycle 35. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab (KEYTRUDA®) and PDS0101 | COMBINATION_PRODUCT | IV infusion of pembrolizumab 200 mg + two 0.5mL sub-cutaneous injections of PDS0101 administered on Cycle 1, 2, 3, 4 and 12. IV infusion of Pembrolizumab 200 mg monotherapy will be administered Cycles 5 - 11 and 13 - 35. |
Inclusion Criteria: * The participant (or legally acceptable representative if applicable) provides written informed consent for the study. * Be ≥18 years of age on the day of signing the informed consent. * Checkpoint-naïve subjects: Have a history of histologically- confirmed diagnosis of squamou...