Renal Cell Carcinoma Clinical Trial
Official title:
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
| Verified date | January 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 437 |
| Est. completion date | March 11, 2025 |
| Est. primary completion date | April 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0100 | Capital Federal | Buenos Aires |
| Argentina | Local Institution - 0011 | Ciudad Autónoma de Buenos Aires | Buenos Aires |
| Argentina | Local Institution - 0005 | Cordoba | |
| Argentina | Local Institution - 0060 | Mar del Plata | Buenos Aires |
| Argentina | Local Institution - 0025 | Rio Cuarto | Cordoba |
| Argentina | Local Institution - 0002 | San Juan | |
| Argentina | Local Institution - 0001 | Viedma | Río Negro |
| Austria | Local Institution - 0033 | Graz | |
| Austria | Local Institution - 0031 | Vienna | |
| Austria | Local Institution - 0032 | Wels | |
| Chile | Local Institution - 0017 | Independencia | Santiago |
| Chile | Local Institution - 0003 | Santiago | Metropolitana |
| Chile | Local Institution - 0034 | Santiago | Metropolitana |
| Chile | Local Institution - 0004 | Vina del Mar | Valparaiso |
| Chile | Local Institution - 0012 | Vina del Mar | Valparaiso |
| Czechia | Local Institution - 0020 | Brno | Jihomoravský Kraj |
| Czechia | Local Institution - 0097 | Brno | |
| Czechia | Local Institution - 0019 | Praha 10 | |
| Czechia | Local Institution - 0018 | Praha 4 | |
| France | Local Institution - 0069 | Angers | |
| France | Local Institution - 0073 | ANGERS Cedex 2 | |
| France | Local Institution - 0075 | Besançon Cedex | |
| France | Local Institution - 0074 | Brest | |
| France | Local Institution - 0094 | Caen | |
| France | Local Institution - 0081 | Hyeres | |
| France | Local Institution - 0080 | La Tronche | |
| France | Local Institution - 0071 | Marseille Cedex 9 | |
| France | Local Institution - 0078 | Nancy | Meurthe-et-Moselle |
| France | Local Institution - 0096 | Nice | Alpes-Maritimes |
| France | Local Institution - 0092 | Paris | |
| France | Local Institution - 0093 | Strasbourg Cedex | |
| France | Local Institution - 0072 | Suresnes | |
| France | Local Institution - 0091 | Valenciennes | Nord |
| France | Local Institution - 0068 | Villejuif | |
| Greece | Local Institution - 0023 | Athens | |
| Greece | Local Institution - 0024 | Larissa | |
| Italy | Local Institution - 0014 | Arezzo | |
| Italy | Local Institution - 0016 | Aviano (PN) | |
| Italy | Local Institution - 0082 | Brescia | Lombardia |
| Italy | Local Institution - 0021 | Milan | |
| Italy | Local Institution - 0015 | Parma | |
| Italy | Local Institution - 0077 | Roma | |
| Mexico | Local Institution - 0008 | Chihuahua | |
| Mexico | 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 - 0067 | Monterrey | Nuevo LEON |
| Mexico | Local Institution - 0046 | Querétaro | |
| Poland | Local Institution - 0030 | Biala Podlaska | |
| Poland | Local Institution - 0095 | Bydgoszcz | |
| Poland | Local Institution - 0062 | Bytom | |
| Poland | Local Institution - 0026 | Gdansk | |
| Poland | Local Institution - 0029 | Poznan | |
| Poland | Local Institution - 0027 | Warszawa | |
| Portugal | Local Institution - 0050 | Lisboa | |
| Romania | Local Institution - 0061 | Bucharest | |
| Romania | Local Institution - 0056 | Cluj-Napoca | |
| Romania | Local Institution - 0065 | Craiova | |
| Russian Federation | Local Institution - 0058 | Novosibirsk | |
| Russian Federation | Local Institution - 0054 | Saint Petersburg | Sankt-Peterburg |
| Spain | Local Institution - 0037 | Barcelona | |
| Spain | Local Institution - 0038 | Barcelona | |
| Spain | Local Institution - 0042 | Cordoba | |
| Spain | Local Institution - 0035 | Madrid | |
| Spain | Local Institution - 0036 | Madrid | |
| Spain | Local Institution - 0045 | Pamplona | |
| Spain | Local Institution - 0039 | Sabadell | |
| Spain | Local Institution - 0043 | Santander | |
| Spain | Local Institution - 0044 | Santiago Compostela | |
| Spain | Local Institution - 0041 | Sevilla | |
| Spain | Local Institution - 0040 | Valencia | |
| United States | Local Institution - 0053 | Athens | Georgia |
| United States | Local Institution - 0066 | Boston | Massachusetts |
| United States | Local Institution - 0086 | Boston | Massachusetts |
| United States | Local Institution - 0088 | Boston | Massachusetts |
| United States | Local Institution - 0084 | Charleston | South Carolina |
| United States | Local Institution - 0013 | Washington | District of Columbia |
| United States | The Reading Hosp Med Ctr Reg Cancer Ctr | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Austria, Chile, Czechia, France, Greece, Italy, Mexico, Poland, Portugal, Romania, Russian Federation, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival (PFS) by blinded independent central review (BICR) | Up to 34 months | ||
| Primary | Objective response rate (ORR) by BICR | Up to 23 months | ||
| Secondary | Overall survival (OS) | Up to 4 years | ||
| Secondary | Overall response rate (ORR) by investigator | Up to 4 years | ||
| Secondary | Disease control rate (DCR) by investigator | Up to 4 years | ||
| Secondary | Duration of response (DoR) by investigator | Up to 4 years | ||
| Secondary | Time to objective response (TTR) by investigator | Up to 4 years | ||
| Secondary | Progression Free Survival (PFS) by investigator | Up to 4 years | ||
| Secondary | Progression free survival secondary objective (PFS2) by investigator | Up to 4 years | ||
| Secondary | Disease control rate (DCR) by BICR | Up to 4 years | ||
| Secondary | Duration of response (DoR) by BICR | Up to 4 years | ||
| Secondary | Time to objective response (TTR) by BICR | Up to 4 years | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to 4 years | ||
| Secondary | Incidence of drug-related AEs | Up to 4 years | ||
| Secondary | Incidence of Severe Adverse Events (SAEs) | Up to 4 years | ||
| Secondary | Incidence of drug-related SAEs | Up to 4 years | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 4 years | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Coagulation tests | Up to 4 years | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 4 years | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory results: Serology tests | Up to 4 years | ||
| Secondary | PFS based on gene expression (GEP) signatures | Up to 4 years | ||
| Secondary | Objective response rate (ORR) based on GEP signatures | Up to 4 years | ||
| Secondary | OS based on GEP signatures | Up to 4 years | ||
| Secondary | OS based on programmed cell death protein ligand-1 (PD-L1) expression | Up to 4 years | ||
| Secondary | ORR by BICR based on PD-L1 expression | Up to 4 years | ||
| Secondary | PFS by BICR based on PD-L1 expression | Up to 4 years |
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