A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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
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Renal Cell Carcinoma

Intervention / Treatment
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* Biological: Nivolumab
* Biological: Ipilimumab
* Other: Ipilimumab placebo


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab + ipilimumab<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Nivolumab + ipilimumab placebo<br> | Other: Ipilimumab placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |