Metastatic renal cell carcinoma
Conditions
Brief summary
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Overall Survival (OS)
Detailed description
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Drug Due to an AE, Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants, Overall Survival (OS) Rate at Month 12 in All Participants, Overall Survival (OS) Rate at Month 18 in All Participants, Overall Survival (OS) Rate at Month 24 in All Participants, Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score, Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Drug Due to an AE, Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants, Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants, Overall Survival (OS) Rate at Month 12 in All Participants, Overall Survival (OS) Rate at Month 18 in All Participants, Overall Survival (OS) Rate at Month 24 in All | — |
Countries
Czechia, France, Germany, Hungary, Ireland, Poland, Spain