Squamous cell carcinoma of the head and neck (SCCHN)
Conditions
Brief summary
1. Confirmed objective response rate
Detailed description
1. Duration of Response, 2. Progression free survival, 3. Overall survival, 4. Progression free survival rate at 6 months, 5. Overall survival rate at 6 months and 12 months, 6.Time to confirmed deterioration in patient-reported physical functioning, 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, 8. Serum concentration of atezolizumab and tiragolumab at specified timepoints, 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and during the study, 10.Prevalence of ADAs to tiragolumab at baseline and during the study
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Confirmed objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of Response, 2. Progression free survival, 3. Overall survival, 4. Progression free survival rate at 6 months, 5. Overall survival rate at 6 months and 12 months, 6.Time to confirmed deterioration in patient-reported physical functioning, 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, 8. Serum concentration of atezolizumab and tiragolumab at specified timepoints, 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and during the study, 10.Prevalence of ADAs to tiragolumab at baseline and during the study | — |
Countries
Czechia, France, Greece, Hungary, Poland, Spain
Outcome results
None listed