Head and Neck, Neoplasms
Conditions
Brief summary
Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per BICR, • Salvage surgery at the primary tumor site when invasive cancer is present, • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present, • Death from any cause.
Detailed description
OS, defined as time from randomization to death from any cause, Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per investigator assessment. • Salvage surgery at the primary tumor site when invasive cancer is present. • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present. • Death from any cause., Frequency and severity of TEAEs, immune-mediated TEAEs, SAEs TEAE/SAEs leading to dose delays, withdrawal or death. Clinically significant changes in laboratory, vital signs, and safety assessment parameters, Serum concentrations and relevant PK parameters (C-EoI and C trough) for dostarlimab, Incidence of ADA against dostarlimab
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per BICR, • Salvage surgery at the primary tumor site when invasive cancer is present, • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present, • Death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as time from randomization to death from any cause, Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per investigator assessment. • Salvage surgery at the primary tumor site when invasive cancer is present. • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present. • Death from any cause., Frequency and severity of TEAEs, immune-mediated TEAEs, SAEs TEAE/SAEs leading to dose delays, withdrawal or death. Clinically significant changes in laboratory, vital signs, and safety assessment parameters, Serum concentrations and relevant PK parameters (C-EoI and C trough) for dostarlimab, Incidence of ADA against dostarlimab | — |
Countries
Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Norway, Poland, Portugal, Romania, Spain, Sweden