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

Phase 3

Active, not recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: Nivolumab; Other: Ipilimumab placebo; Biological: Ipilimumab

• Registration Number: NCT03873402
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Study Start: 2019-06-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-04-30
• Study Completion: 2025-03-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 437

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab + ipilimumab	Nivolumab	-
Nivolumab + ipilimumab	Ipilimumab	-
Nivolumab + ipilimumab placebo	Ipilimumab placebo	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) by BICR	Up to 23 months
Progression free survival (PFS) by blinded independent central review (BICR)	Up to 34 months

Secondary Outcome Measures

Name	Time	Method
PFS based on gene expression (GEP) signatures	Up to 4 years
Progression Free Survival (PFS) by investigator	Up to 4 years
Duration of response (DoR) by BICR	Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests	Up to 4 years
Objective response rate (ORR) based on GEP signatures	Up to 4 years
PFS by BICR based on PD-L1 expression	Up to 4 years
Overall response rate (ORR) by investigator	Up to 4 years
Incidence of drug-related AEs	Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Serology tests	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
Overall survival (OS)	Up to 4 years
Disease control rate (DCR) 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
Incidence of drug-related SAEs	Up to 4 years
Time to objective response (TTR) by investigator	Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests	Up to 4 years
Duration of response (DoR) by investigator	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 Severe Adverse Events (SAEs)	Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 4 years

Trial Locations

Locations (78)

Local Institution - 0038; 🇪🇸 Barcelona, Spain

Local Institution - 0065; 🇷🇴 Craiova, Romania

Local Institution - 0013; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0066; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0011; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0060; 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Local Institution - 0025; 🇦🇷 Rio Cuarto, Cordoba, Argentina

Local Institution - 0084; 🇺🇸 Charleston, South Carolina, United States

Local Institution - 0005; 🇦🇷 Cordoba, Argentina

Local Institution - 0002; 🇦🇷 San Juan, Argentina

Local Institution - 0033; 🇦🇹 Graz, Austria

Local Institution - 0032; 🇦🇹 Wels, Austria

Local Institution - 0003; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0034; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0092; 🇫🇷 Paris, France

Local Institution - 0017; 🇨🇱 Independencia, Santiago, Chile

Local Institution - 0004; 🇨🇱 Vina del Mar, Valparaiso, Chile

Local Institution - 0073; 🇫🇷 ANGERS Cedex 2, France

Local Institution - 0023; 🇬🇷 Athens, Greece

Local Institution - 0026; 🇵🇱 Gdansk, Poland

Local Institution - 0029; 🇵🇱 Poznan, Poland

Local Institution - 0027; 🇵🇱 Warszawa, Poland

Local Institution - 0050; 🇵🇹 Lisboa, Portugal

Local Institution - 0054; 🇷🇺 Saint Petersburg, Sankt-Peterburg, Russian Federation

Local Institution - 0078; 🇫🇷 Nancy, Meurthe-et-Moselle, France

Local Institution - 0094; 🇫🇷 Caen, France

Local Institution - 0053; 🇺🇸 Athens, Georgia, United States

Local Institution - 0088; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0086; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0100; 🇦🇷 Capital Federal, Buenos Aires, Argentina

The Reading Hosp Med Ctr Reg Cancer Ctr; 🇺🇸 West Reading, Pennsylvania, United States

Local Institution - 0001; 🇦🇷 Viedma, Río Negro, Argentina

Local Institution - 0031; 🇦🇹 Vienna, Austria

Local Institution - 0012; 🇨🇱 Vina del Mar, Valparaiso, Chile

Local Institution - 0020; 🇨🇿 Brno, Jihomoravský Kraj, Czechia

Local Institution - 0018; 🇨🇿 Praha 4, Czechia

Local Institution - 0019; 🇨🇿 Praha 10, Czechia

Local Institution - 0097; 🇨🇿 Brno, Czechia

Local Institution - 0096; 🇫🇷 Nice, Alpes-Maritimes, France

Local Institution - 0091; 🇫🇷 Valenciennes, Nord, France

Local Institution - 0075; 🇫🇷 Besançon Cedex, France

Local Institution - 0069; 🇫🇷 Angers, France

Local Institution - 0074; 🇫🇷 Brest, France

Local Institution - 0081; 🇫🇷 Hyeres, France

Local Institution - 0071; 🇫🇷 Marseille Cedex 9, France

Local Institution - 0080; 🇫🇷 La Tronche, France

Local Institution - 0093; 🇫🇷 Strasbourg Cedex, France

Local Institution - 0072; 🇫🇷 Suresnes, France

Local Institution - 0068; 🇫🇷 Villejuif, France

Local Institution - 0082; 🇮🇹 Brescia, Lombardia, Italy

Local Institution - 0014; 🇮🇹 Arezzo, Italy

Local Institution - 0024; 🇬🇷 Larissa, Greece

Local Institution - 0016; 🇮🇹 Aviano (PN), Italy

Local Institution - 0021; 🇮🇹 Milan, Italy

Local Institution - 0077; 🇮🇹 Roma, Italy

Local Institution - 0015; 🇮🇹 Parma, Italy

Local Institution - 0006; 🇲🇽 Ciudad de Mexico, Distrito Federal, Mexico

Local Institution - 0009; 🇲🇽 Mexico, Distrito Federal, Mexico

Local Institution - 0010; 🇲🇽 Mexico, Distrito Federal, Mexico

Local Institution - 0046; 🇲🇽 Querétaro, Mexico

Local Institution - 0008; 🇲🇽 Chihuahua, Mexico

Local Institution - 0067; 🇲🇽 Monterrey, Nuevo LEON, Mexico

Local Institution - 0030; 🇵🇱 Biala Podlaska, Poland

Local Institution - 0095; 🇵🇱 Bydgoszcz, Poland

Local Institution - 0062; 🇵🇱 Bytom, Poland

Local Institution - 0061; 🇷🇴 Bucharest, Romania

Local Institution - 0056; 🇷🇴 Cluj-Napoca, Romania

Local Institution - 0058; 🇷🇺 Novosibirsk, Russian Federation

Local Institution - 0037; 🇪🇸 Barcelona, Spain

Local Institution - 0042; 🇪🇸 Cordoba, Spain

Local Institution - 0035; 🇪🇸 Madrid, Spain

Local Institution - 0045; 🇪🇸 Pamplona, Spain

Local Institution - 0036; 🇪🇸 Madrid, Spain

Local Institution - 0043; 🇪🇸 Santander, Spain

Local Institution - 0044; 🇪🇸 Santiago Compostela, Spain

Local Institution - 0039; 🇪🇸 Sabadell, Spain

Local Institution - 0040; 🇪🇸 Valencia, Spain

Local Institution - 0041; 🇪🇸 Sevilla, Spain