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

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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

Condition: Renal Cell Carcinoma

Intervention:

  • Biological: Nivolumab
  • Biological: Ipilimumab
  • Other: Ipilimumab placebo

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03873402

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Progression free survival (PFS)
  • Time Frame: Up to 34 months
  • Safety Issue:
  • Measure: Objective Response Rate (ORR)
  • Time Frame: Up to 23 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Overall response rate (ORR)
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Disease control rate (DCR)
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Duration of response (DoR)
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Time to objective response (TTR)
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: PFS
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Incidence of adverse events (AEs)
  • Time Frame: Up to 4 years
  • Safety Issue:

Estimated Enrollment: 418

Study Start Date: April 29, 2019

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 CT or MRI per 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:

  • 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 could apply

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email:

Locations:

  • Local Institution
  • Stamford Connecticut 06904 United States
  • Local Institution
  • Washington District of Columbia 20007 United States
  • Local Institution
  • Orlando Florida 32803 United States
  • University Cancer Blood Ctr
  • Athens Georgia 30607 United States
  • Local Institution
  • Chicago Illinois 60611 United States
  • Local Institution
  • Chicago Illinois 60637 United States
  • Local Institution
  • Boston Massachusetts 02114 United States
  • Local Institution
  • Boston Massachusetts 02215 United States
  • Local Institution
  • Boston Massachusetts 02215 United States
  • Local Institution
  • Hackensack New Jersey 07601 United States
  • Local Institution
  • Buffalo New York 14263 United States
  • Local Institution
  • Lake Success New York 11042 United States
  • Local Institution
  • West Reading Pennsylvania 19611 United States
  • Charleston Hematology Oncology Associates, Pa
  • Charleston South Carolina 29414 United States
  • Local Institution
  • Ciudad Autonoma de Buenos Aires Buenos Aires 1280 Argentina
  • Local Institution
  • Mar del Plata Buenos Aires 7500 Argentina
  • Local Institution
  • Rio Cuarto Cordoba 5800 Argentina
  • Local Institution
  • Viedma RIO Negro 8500 Argentina
  • Local Institution
  • Buenos Aires 1417 Argentina
  • Local Institution
  • Cordoba X5004FHP Argentina
  • Local Institution
  • San Juan 5402 Argentina
  • Lkh-Univ.Klinikum Graz
  • Graz 8036 Austria
  • Akh
  • Vienna 1090 Austria
  • Klinikum Wels-Grieskirchen Gmbh
  • Wels 4600 Austria
  • Local Institution
  • Santiago de Chile Metropolitana Chile
  • Local Institution
  • Santiago Metropolitana 8330024 Chile
  • Local Institution
  • Independencia Santiago Chile
  • Local Institution
  • Vina del Mar Valparaiso 2520598 Chile
  • Local Institution
  • Vina del Mar Valparaiso 2540364 Chile
  • Local Institution
  • Brno 656 91 Czechia
  • Local Institution
  • Praha 10 100 34 Czechia
  • Onkologicka klinika 1. LF UK a TN
  • Praha 4 140 59 Czechia
  • Chu Angers
  • Angers Cedex 10 49933 France
  • Local Institution
  • Besancon Cedex 25030 France
  • Local Institution
  • Brest 29200 France
  • Local Institution
  • Hyeres 83400 France
  • Local Institution
  • La Tronche 38043 France
  • Local Institution
  • Marseille Cedex 9 13273 France
  • Local Institution
  • Nancy 54100 France
  • Local Institution
  • Nice 06189 France
  • Local Institution
  • Paris 75014 France
  • Local Institution
  • Saint Herblain 44805 France
  • Local Institution
  • Strasbourg Cedex 67091 France
  • Local Institution
  • Suresnes 92151 France
  • Local Institution
  • Toulouse Cedex 9 31059 France
  • Centre de cancerologie Les Dentellieres
  • Valenciennes 59300 France
  • Local Institution
  • Villejuif 94800 France
  • Local Institution
  • Athens 15125 Greece
  • Local Institution
  • Larissa 41110 Greece
  • Local Institution
  • Ciudad de Mexico Distrito Federal 06100 Mexico
  • Local Institution
  • Queretaro 76000 Mexico
  • Local Institution
  • Biala Podlaska 21-500 Poland
  • Local Institution
  • Bydgoszcz 85-796 Poland
  • Local Institution
  • Bytom 41-902 Poland
  • Local Institution
  • Gdansk 80-19 Poland
  • Local Institution
  • Krakow 31-115 Poland
  • Local Institution
  • Poznan 60-569 Poland
  • Local Institution
  • Warszawa 02-781 Poland
  • Local Institution
  • Wroclaw 53-413 Poland
  • Local Institution
  • Lisboa 1500-650 Portugal
  • Local Institution
  • Lisboa 1649-035 Portugal
  • Local Institution
  • Loures 2674-514 Portugal
  • Local Institution
  • Porto 4200-072 Portugal
  • Local Institution
  • Bucharest 014142 Romania
  • Local Institution
  • Bucharest 020122 Romania
  • Local Institution
  • Cluj-Napoca 400015 Romania
  • Local Institution
  • Constanta 900591 Romania
  • Local Institution
  • Craiova 200347 Romania
  • Local Institution
  • Saint-Petersburg 194044 Russian Federation
  • Local Institution
  • Barcelona 08003 Spain
  • Local Institution
  • Barcelona 08035 Spain
  • Local Institution
  • Cordoba 14004 Spain
  • Local Institution
  • Madrid 28033 Spain
  • Local Institution
  • Madrid 28046 Spain
  • Local Institution
  • Pamplona 31008 Spain
  • Local Institution
  • Sabadell 08208 Spain
  • Local Institution
  • Santander 39008 Spain
  • Local Institution
  • Santiago Compostela 15706 Spain
  • Local Institution
  • Sevilla 41013 Spain
  • Local Institution
  • Valencia 46009 Spain

View trial on ClinicalTrials.gov

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