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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04534205 | A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 | PHASE2 | RECRUITING | 350 | — | — | Jan 7, 2021 | Apr 1, 2029 | May 22, 2026 | 195 | United States, Argentina +21 |
TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, and fatal TEAEs, by relationship.
OS defined as the time from randomization to death from any cause.
PFS defined as the time from randomization to the first objective tumor progression (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] assessed by the blinded independent central review \[BICR\]), or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Part A (Safety Run-In) - BNT113 + Pembrolizumab | EXPERIMENTAL | Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. |
| Part B (Randomized phase) - BNT113 + Pembrolizumab | EXPERIMENTAL | BNT113 in combination with pembrolizumab. |
| Part B (Randomized phase) - Pembrolizumab monotherapy | ACTIVE_COMPARATOR | Pembrolizumab monotherapy. |
| Name | Type | Description |
|---|---|---|
| BNT113 | BIOLOGICAL | IV injection |
| Pembrolizumab | BIOLOGICAL | IV infusion |
Key Inclusion Criteria: * Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures. * Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies. * Patients who have a tumor t...