Renal cell carcinoma (RCC)
Conditions
Brief summary
1. Progression-free survival as assessed by Independent Review Facility (IRF), 2. Overall survival
Detailed description
1. Progression-free survival as assessed by investigators, 2. Investigator- and IRF-assessed objective response rate, 3. Investigator- and IRF-assessed duration of objective response, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results, 7. Atezolizumab concentrations at specified timepoints (for atezolizumab + cabozantinib arm), 8. Cabozantinib concentrations at specified timepoints, 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study (for atezolizumab+ cabozantinib arm)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival as assessed by Independent Review Facility (IRF), 2. Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival as assessed by investigators, 2. Investigator- and IRF-assessed objective response rate, 3. Investigator- and IRF-assessed duration of objective response, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results, 7. Atezolizumab concentrations at specified timepoints (for atezolizumab + cabozantinib arm), 8. Cabozantinib concentrations at specified timepoints, 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study (for atezolizumab+ cabozantinib arm) | — |
Countries
Germany, Poland