- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03873402
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
January 17, 2024 updated by: Bristol-Myers Squibb
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
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
437
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cordoba, Argentina, X5004FHP
- Local Institution - 0005
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San Juan, Argentina, 5400
- Local Institution - 0002
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, 1419
- Local Institution - 0100
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
- Local Institution - 0011
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Mar del Plata, Buenos Aires, Argentina, 7600
- Local Institution - 0060
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Cordoba
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Rio Cuarto, Cordoba, Argentina, 5800
- Local Institution - 0025
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Río Negro
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Viedma, Río Negro, Argentina, R8500ACE
- Local Institution - 0001
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Graz, Austria, 8036
- Local Institution - 0033
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Vienna, Austria, 1090
- Local Institution - 0031
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Wels, Austria, 4600
- Local Institution - 0032
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Metropolitana
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Santiago, Metropolitana, Chile, 8420383
- Local Institution - 0034
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Santiago, Metropolitana, Chile, 8330024
- Local Institution - 0003
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Santiago
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Independencia, Santiago, Chile
- Local Institution - 0017
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Valparaiso
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Vina del Mar, Valparaiso, Chile, 2520598
- Local Institution - 0004
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Vina del Mar, Valparaiso, Chile, 2540364
- Local Institution - 0012
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Brno, Czechia, 656 53
- Local Institution - 0097
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Praha 10, Czechia, 100 34
- Local Institution - 0019
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Praha 4, Czechia, 140 59
- Local Institution - 0018
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Jihomoravský Kraj
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Brno, Jihomoravský Kraj, Czechia, 602 00
- Local Institution - 0020
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ANGERS Cedex 2, France, 49055
- Local Institution - 0073
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Angers, France, 49100
- Local Institution - 0069
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Besançon Cedex, France, 25030
- Local Institution - 0075
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Brest, France, 29200
- Local Institution - 0074
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Caen, France, 14076
- Local Institution - 0094
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Hyeres, France, 83400
- Local Institution - 0081
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La Tronche, France, 38043
- Local Institution - 0080
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Marseille Cedex 9, France, 13273
- Local Institution - 0071
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Paris, France, 75014
- Local Institution - 0092
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Strasbourg Cedex, France, 67091
- Local Institution - 0093
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Suresnes, France, 92151
- Local Institution - 0072
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Villejuif, France, 94800
- Local Institution - 0068
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06189
- Local Institution - 0096
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, France, 54100
- Local Institution - 0078
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Nord
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Valenciennes, Nord, France, 59300
- Local Institution - 0091
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Athens, Greece, 15125
- Local Institution - 0023
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Larissa, Greece, 41110
- Local Institution - 0024
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Arezzo, Italy, 52100
- Local Institution - 0014
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Aviano (PN), Italy, 33081
- Local Institution - 0016
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Milan, Italy, 20141
- Local Institution - 0021
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Parma, Italy, 43100
- Local Institution - 0015
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Roma, Italy, 00128
- Local Institution - 0077
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Lombardia
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Brescia, Lombardia, Italy, 25123
- Local Institution - 0082
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Chihuahua, Mexico, 31000
- Local Institution - 0008
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Querétaro, Mexico, 76000
- Local Institution - 0046
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Distrito Federal
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Ciudad de Mexico, Distrito Federal, Mexico, 06100
- Local Institution - 0006
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Mexico, Distrito Federal, Mexico, 14080
- Local Institution - 0009
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Mexico, Distrito Federal, Mexico, 14080
- Local Institution - 0010
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Nuevo LEON
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Monterrey, Nuevo LEON, Mexico, 64040
- Local Institution - 0067
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Biala Podlaska, Poland, 21-500
- Local Institution - 0030
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Bydgoszcz, Poland, 85-796
- Local Institution - 0095
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Bytom, Poland, 41-902
- Local Institution - 0062
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Gdansk, Poland, 80-219
- Local Institution - 0026
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Poznan, Poland, 61-848
- Local Institution - 0029
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Warszawa, Poland, 02-781
- Local Institution - 0027
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Lisboa, Portugal, 1649-035
- Local Institution - 0050
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Bucharest, Romania, 020122
- Local Institution - 0061
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Cluj-Napoca, Romania, 400015
- Local Institution - 0056
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Craiova, Romania, 200542
- Local Institution - 0065
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Novosibirsk, Russian Federation, 630099
- Local Institution - 0058
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russian Federation, 194044
- Local Institution - 0054
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Barcelona, Spain, 08003
- Local Institution - 0038
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Barcelona, Spain, 08035
- Local Institution - 0037
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Cordoba, Spain, 14004
- Local Institution - 0042
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Madrid, Spain, 28034
- Local Institution - 0036
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Madrid, Spain, 28046
- Local Institution - 0035
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Pamplona, Spain, 31008
- Local Institution - 0045
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Sabadell, Spain, 08208
- Local Institution - 0039
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Santander, Spain, 39008
- Local Institution - 0043
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Santiago Compostela, Spain, 15706
- Local Institution - 0044
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Sevilla, Spain, 41013
- Local Institution - 0041
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Valencia, Spain, 46009
- Local Institution - 0040
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Local Institution - 0013
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Georgia
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Athens, Georgia, United States, 30607
- Local Institution - 0053
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Local Institution - 0066
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Boston, Massachusetts, United States, 02114
- Local Institution - 0088
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Boston, Massachusetts, United States, 02215
- Local Institution - 0086
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Pennsylvania
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West Reading, Pennsylvania, United States, 19611
- The Reading Hosp Med Ctr Reg Cancer Ctr
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South Carolina
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Charleston, South Carolina, United States, 29414
- Local Institution - 0084
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Nivolumab + ipilimumab
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Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
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Experimental: Nivolumab + ipilimumab placebo
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Specified dose on specified days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Progression free survival (PFS) by blinded independent central review (BICR)
Time Frame: Up to 34 months
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Up to 34 months
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Objective response rate (ORR) by BICR
Time Frame: Up to 23 months
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Up to 23 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: Up to 4 years
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Up to 4 years
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Overall response rate (ORR) by investigator
Time Frame: Up to 4 years
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Up to 4 years
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Disease control rate (DCR) by investigator
Time Frame: Up to 4 years
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Up to 4 years
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Duration of response (DoR) by investigator
Time Frame: Up to 4 years
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Up to 4 years
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Time to objective response (TTR) by investigator
Time Frame: Up to 4 years
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Up to 4 years
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Progression Free Survival (PFS) by investigator
Time Frame: Up to 4 years
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Up to 4 years
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Progression free survival secondary objective (PFS2) by investigator
Time Frame: Up to 4 years
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Up to 4 years
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Disease control rate (DCR) by BICR
Time Frame: Up to 4 years
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Up to 4 years
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Duration of response (DoR) by BICR
Time Frame: Up to 4 years
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Up to 4 years
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Time to objective response (TTR) by BICR
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of Adverse Events (AEs)
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of drug-related AEs
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of Severe Adverse Events (SAEs)
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of drug-related SAEs
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of clinically significant changes in clinical laboratory results: Serology tests
Time Frame: Up to 4 years
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Up to 4 years
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PFS based on gene expression (GEP) signatures
Time Frame: Up to 4 years
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Up to 4 years
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Objective response rate (ORR) based on GEP signatures
Time Frame: Up to 4 years
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Up to 4 years
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OS based on GEP signatures
Time Frame: Up to 4 years
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Up to 4 years
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OS based on programmed cell death protein ligand-1 (PD-L1) expression
Time Frame: Up to 4 years
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Up to 4 years
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ORR by BICR based on PD-L1 expression
Time Frame: Up to 4 years
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Up to 4 years
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PFS by BICR based on PD-L1 expression
Time Frame: Up to 4 years
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Up to 4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2019
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
March 11, 2025
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 12, 2019
First Posted (Actual)
March 13, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
- Ipilimumab
Other Study ID Numbers
- CA209-8Y8
- 2018-004695-35 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
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