Renal Cell Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Adults greater than or equal to (>/=) 18 years of age - Unresectable advanced or metastatic RCC with clear cell histology and/or component of sarcomatoid carcinoma - Evaluable Memorial Sloan Kettering Cancer Center (MSKCC) risk score - Measurable disease as defined by RECIST v1.1 - Karnofsky performance status (KPS) >/=70% - Adequate hematologic and end-organ function
Exclusion criteria
Exclusion criteria: - Radiotherapy for RCC within 14 days prior to treatment - Central nervous system (CNS) disease - Uncontrolled pleural effusion, pericardial effusion, or ascites - Uncontrolled hypercalcemia - Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death - Life expectancy less than () 460 milliseconds (ms)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory RECIST version 1.1, etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics RECIST version 1.1, modified RECIST critera, etc. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America