A Phase 3, Open-label, Randomized, Noninferiority Trial of the Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Had Received Prior Systemic Therapy

Metastatic Clear Cell Renal Cell Carcinoma

Time-averaged serum concentration over 28 days (Cavgd28), Trough serum concentration at steady-state (Cminss)

- Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ], - Trough serum concentration at day 28 (Cmind28) [ Time Frame: At 28 days ], - Maximum serum concentration after the first dose (Cmax1) [ Time Frame: Up to 7 days ], - Peak serum concentration at steady-state (Cmaxss) [ Time Frame: Up to 4 months ], - Steady-state average serum concentration (Cavgss) [ Time Frame: Up to 4 months ], - Observed trough nivolumab serum concentration (Ctrough) at Week 17 [ Time Frame: At Week 17 ], - Incidence of adverse events (AEs) [ Time Frame: Up to 2 years 3 months ], - Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years 3 months ], - Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ], - Incidence of deaths [ Time Frame: Up to 5 years ], - Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2 years 3 months ], - Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 2 years 3 months ], - Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ], - Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ], - Efficacy parameters: DCR by BICR at end of study [ Time Frame: Up to 5 years ], - Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ], - Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ], - Efficacy parameters: DOR by BICR at end of study [ Time Frame: Up to 5 years, - Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ], - Efficacy parameters: TTR by BICR with a minimum of 12 months followup [ Time Frame: Up to 3 years ], - Efficacy parameters: TTR by BICR at end of study [ Time Frame: Up to 5 years ], - Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ], - Efficacy parameters: PFS by BICR with a minimum of 12 months followup [ Time Frame: Up to 3 years ], - Efficacy parameters: PFS by BICR at end of study [ Time Frame: Up to 5 years ], - Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ], - Efficacy parameters: OS with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ], - Efficacy parameters: OS at end of study [ Time Frame: Up to 5 years ], - Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ], - Efficacy parameters: ORR by BICR at end of study [ Time Frame: Up to 5 years ], - Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions [ Time Frame: Up to 2 years 3 months ], - Incidence of local injection- or infusion-site reactions [ Time Frame: Up to 2 years 3 months ], - Percentage of participants who develop anti-nivolumab antibodies, if applicable [ Time Frame: Up to 2 years 3 months ], - Percentage of participants who develop neutralizing antibodies, if applicable [ Time Frame: Up to 2 years 3 months ]

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