Renal Cell Carcinoma
Conditions
Brief summary
The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.
Interventions
BIOLOGICALNivolumab
Specified dose on specified days
BIOLOGICALIpilimumab
Specified dose on specified days
OTHERIpilimumab placebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features. * Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC). * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria. * No prior systemic therapy for RCC * Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).
Exclusion criteria
* Any active central nervous system (CNS) metastases. * Active, known, or suspected autoimmune disease. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) by blinded independent central review (BICR) | Up to 34 months |
| Objective response rate (ORR) by BICR | Up to 23 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to 4 years |
| Overall response rate (ORR) by investigator | Up to 4 years |
| Disease control rate (DCR) by investigator | Up to 4 years |
| Duration of response (DoR) by investigator | Up to 4 years |
| Time to objective response (TTR) by investigator | Up to 4 years |
| Progression Free Survival (PFS) by investigator | Up to 4 years |
| Progression free survival secondary objective (PFS2) by investigator | Up to 4 years |
| Disease control rate (DCR) by BICR | Up to 4 years |
| Duration of response (DoR) by BICR | Up to 4 years |
| Time to objective response (TTR) by BICR | Up to 4 years |
| Incidence of Adverse Events (AEs) | Up to 4 years |
| Incidence of drug-related AEs | Up to 4 years |
| Incidence of Severe Adverse Events (SAEs) | Up to 4 years |
| Incidence of drug-related SAEs | Up to 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Coagulation tests | Up to 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 4 years |
| Incidence of clinically significant changes in clinical laboratory results: Serology tests | Up to 4 years |
| PFS based on gene expression (GEP) signatures | Up to 4 years |
| Objective response rate (ORR) based on GEP signatures | Up to 4 years |
| OS based on GEP signatures | Up to 4 years |
| OS based on programmed cell death protein ligand-1 (PD-L1) expression | Up to 4 years |
| ORR by BICR based on PD-L1 expression | Up to 4 years |
| PFS by BICR based on PD-L1 expression | Up to 4 years |
Countries
Argentina, Austria, Chile, Czechia, France, Greece, Italy, Mexico, Poland, Portugal, Romania, Russia, Spain, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed