Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma
Conditions
Brief summary
PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first, as assessed by BICR according to RECIST 1.1.
Detailed description
OS is defined as the time from date of randomization until the date of death from any cause., ORR is defined as the proportion of patients who have achieved confirmed complete response (CR) or confirmed partial response (PR) to study therapy, as assessed by BICR according to RECIST 1.1., Duration of response is measured from the time of first response (CR or PR) until the date of first documented PD or death, whichever comes first, as assessed by BICR according to RECIST 1.1., Disease control rate (DCR) is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 16 weeks from date of randomization, as assessed by BICR according to RECIST 1.1., The incidence and severity of treatment-emergent adverse events and treatment-emergent serious adverse events, and any clinically meaningful trends in safety parameters., Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index – Disease Related Symptoms (NFKSI-DRS) Items 1-9 sub-scale score.
Interventions
Sponsors
Arcus Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first, as assessed by BICR according to RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS is defined as the time from date of randomization until the date of death from any cause., ORR is defined as the proportion of patients who have achieved confirmed complete response (CR) or confirmed partial response (PR) to study therapy, as assessed by BICR according to RECIST 1.1., Duration of response is measured from the time of first response (CR or PR) until the date of first documented PD or death, whichever comes first, as assessed by BICR according to RECIST 1.1., Disease control rate (DCR) is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 16 weeks from date of randomization, as assessed by BICR according to RECIST 1.1., The incidence and severity of treatment-emergent adverse events and treatment-emergent serious adverse events, and any clinically meaningful trends in safety parameters., Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Sy | — |
Countries
Czechia, France, Germany, Italy, Netherlands, Poland, Romania, Spain
Outcome results
None listed