A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined with Ipilimumab versus Nivolumab Monotherapy for Patients with Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

Conditions

Advanced Renal Cell Carcinoma with Intermediate- or Poor-Risk Factors

Brief summary

Progression free survival (PFS) by BICR, Overall Response Rate (ORR) by BICR

Detailed description

Overall survival (OS), Overall response rate (ORR) by Investigator, Disease control rate (DCR) by Investigator and by blinded independent central review (BICR), Duration of response (DoR) by Investigator and by blinded independent central review (BICR), Time to objective response (TTR) by Investigator and by blinded independent central review (BICR), Progression free survival (PFS) and PFS2 per Investigator, Incidence of adverse events (AEs), Serious Adverse Events, drug - related SAEs and significant changes in laboratory tests (Hematology tests, Coagulation tests), Clinical Chemistry Tests and Serology Tests), PFS, ORR and OS based on GEP signatures, Overall Survival based on programmed cell death protein ligand-1 (PD-L1) expression, Overall response rate (ORR) by BICR based on PD-L1 expression, Progression Free Survival (PFS) by BICR based on PD-L1 expression)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGSodium chloride 0.9%

DRUGsolution for infusion

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGIpilimumab

DRUG5% Dextrose

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS) by BICR, Overall Response Rate (ORR) by BICR	—

Secondary

Measure	Time frame
Overall survival (OS), Overall response rate (ORR) by Investigator, Disease control rate (DCR) by Investigator and by blinded independent central review (BICR), Duration of response (DoR) by Investigator and by blinded independent central review (BICR), Time to objective response (TTR) by Investigator and by blinded independent central review (BICR), Progression free survival (PFS) and PFS2 per Investigator, Incidence of adverse events (AEs), Serious Adverse Events, drug - related SAEs and significant changes in laboratory tests (Hematology tests, Coagulation tests), Clinical Chemistry Tests and Serology Tests), PFS, ORR and OS based on GEP signatures, Overall Survival based on programmed cell death protein ligand-1 (PD-L1) expression, Overall response rate (ORR) by BICR based on PD-L1 expression, Progression Free Survival (PFS) by BICR based on PD-L1 expression)	—

Measure

Time frame

Overall survival (OS), Overall response rate (ORR) by Investigator, Disease control rate (DCR) by Investigator and by blinded independent central review (BICR), Duration of response (DoR) by Investigator and by blinded independent central review (BICR), Time to objective response (TTR) by Investigator and by blinded independent central review (BICR), Progression free survival (PFS) and PFS2 per Investigator, Incidence of adverse events (AEs), Serious Adverse Events, drug - related SAEs and significant changes in laboratory tests (Hematology tests, Coagulation tests), Clinical Chemistry Tests and Serology Tests), PFS, ORR and OS based on GEP signatures, Overall Survival based on programmed cell death protein ligand-1 (PD-L1) expression, Overall response rate (ORR) by BICR based on PD-L1 expression, Progression Free Survival (PFS) by BICR based on PD-L1 expression)

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Countries

Austria, Czechia, France, Greece, Italy, Poland, Romania, Spain

Outcome results

None listed