Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VB10.16 · 1 trial · 2 indications
Proportion of patient with Dose Limiting Toxicities (DLTs).
Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1.
PFS defined as the time from randomization to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Phase1: Dose Escalation: 3 mg VB10.16 + Pembrolizumab | EXPERIMENTAL | 3 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles Pembrolizumab will be given as standard of care/ background medication via i.v. infusions |
| Phase 1: Dose Escalation: 6 mg VB10.16 + Pembrolizumab | EXPERIMENTAL | 6 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps or gluteus muscles Pembrolizumab will be given as standard of care/ background medication via i.v. infusions |
| Phase 1: Dose Escalation: 9 mg VB10.16 + Pembrolizumab | EXPERIMENTAL | 9 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps and/or gluteus muscle Pembrolizumab will be given as standard of care/ background medication via i.v. infusions |
| Phase 2: Arm A: VB10.16 (recommended Phase 2 Dose) + Pembrolizumab | EXPERIMENTAL | Patients randomized to receive VB10.16 at the Recommended Phase 2 Dose (RP2D) in combination with pembrolizumab. Patients will receive pembrolizumab plus the selected RP2D of VB10.16. |
| Phase 2: Active comparator ph 2, Arm B: Pembrolizumab Monotherapy | EXPERIMENTAL | Patients randomized to receive pembrolizumab monotherapy. |
| Name | Type | Description |
|---|---|---|
| VB10.16 | BIOLOGICAL | Intramuscular injection using a PharmaJet needle-free injection system |
| Pembrolizumab | DRUG | Intravenous infusion. |
KEY INCLUSION CRITERIA: * ≥18 years of age (or as per national legal age of trial consent, whichever is higher) at date of signing the informed consent form (ICF). * Histologically or cytologically confirmed r/m HNSCC, located in the oropharynx, considered incurable by local therapy and eligible fo...
VB10.16 is an investigational monoclonal antibody being developed for the treatment of HPV positive oropharyngeal squamous cell carcinoma, a type of head and neck cancer. It is currently being studied in combination with pembrolizumab in patients with this condition.
VB10.16 is a monoclonal antibody designed to target HPV positive oropharyngeal squamous cell carcinoma. The specific molecular target is not disclosed in the available information, but the drug is being evaluated for its safety and efficacy in this patient population.
VB10.16 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
VB10.16 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to assess its safety and efficacy.
VB10.16 is being studied in a Phase 1 clinical trial with the identifier NCT06016920. This trial is evaluating the safety and efficacy of VB10.16 in combination with pembrolizumab in patients with HPV positive oropharyngeal squamous cell carcinoma and head and neck squamous cell carcinoma. The trial is currently recruiting participants.
No, VB10.16 is not the same as pembrolizumab. VB10.16 is an investigational monoclonal antibody being developed by Merck, while pembrolizumab is an approved immunotherapy drug. The two are being studied together in a clinical trial for HPV positive oropharyngeal squamous cell carcinoma.