Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT113 · 2 trials · 8 indications
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.
Safe and tolerable dose of clinically disease free patients (Arm 1A) - Determination of a suitable dose of HPV RNA
| 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. |
| RNA Vaccine A | EXPERIMENTAL | Arm 1A: 15 (6+9) patients with previously treated HPV16+ head and neck squamous cell carcinoma receiving increasing doses of HPV vaccine. \- COMPLETE no longer recruiting |
| RAN Vaccine B | EXPERIMENTAL | Arm 1B: 29 (15+14) patients with HPV16+ advanced disease receiving increasing doses of HPV vaccine. OPEN to recruitment |
| 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...