Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembroluzimab · 1 trial · 2 indications
PFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the time from the date of randomization to first invasive local, regional, distant progression, invasive second head and neck primary, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation. Progression should be confirmed by biopsy or lymph node removal when feasible, but may also be determined based on clinical or pathologic evidence at the discretion of the treating investigator.
Grade 3 or 4 AE rate is defined as the proportion of participants who experience grade 3 or 4 adverse events during study treatment. AEs are summarized and graded based on CTCAE 5.0.
| Arm | Type | Description |
|---|---|---|
| Adjuvant Pembroluzimab | EXPERIMENTAL | * Cycle 1 through Cycle 9 (42-day cycles) * Days 1-378: Predetermined dose of Pembrolizumab once every 6 weeks, up to 9 cycles * Follow up for up to 2 years |
| Observation | ACTIVE_COMPARATOR | Cycle 1 through Cycle 9 (42-day cycles) Days 1-378: Standard of care observation Device: NavDx® TTMV-HPV DNA testing (used for risk stratification and treatment assignment) Follow up for up to 2 years |
| Name | Type | Description |
|---|---|---|
| Pembroluzimab | DRUG | monoclonal antibody, single-dose vial via intravenous (through the arm) infusion, per protocol |
| Observation | OTHER | Standard of care observation |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed, stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. Participants with HPV-associa...
Pembroluzimab is an investigational antibody being studied for the treatment of HPV-positive Oropharyngeal Squamous Cell Carcinoma. It is currently in Phase 2 clinical development, with an active trial evaluating its use in this patient population.
Pembroluzimab is a monoclonal antibody (target class -mab) that is being investigated for its role in oncology. Its specific molecular target is not disclosed in the available information.
Pembroluzimab is being developed by Merck & Company, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol MRK.
Pembroluzimab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for any indication.
Pembroluzimab is being studied in a Phase 2 clinical trial with the identifier NCT07513324. The trial is titled 'Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)' and is expected to enroll 116 participants in the United States.
Pembroluzimab is the drug name provided in the data. No alternative names are listed, so it is not confirmed to be the same as pembrolizumab or any other drug.