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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03873402
Collaborator
(none)
437
Enrollment
77
Locations
2
Arms
68.7
Anticipated Duration (Months)
5.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Nivolumab
  • Biological: Ipilimumab
  • Other: Ipilimumab placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
437 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 21, 2019
Anticipated Primary Completion Date :
Sep 14, 2022
Anticipated Study Completion Date :
Mar 11, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab + ipilimumab

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo

    • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy

    		•
    Experimental: Nivolumab + ipilimumab placebo

    Other: Ipilimumab placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) by blinded independent central review (BICR) [Up to 34 months]

    2. Objective response rate (ORR) by BICR [Up to 23 months]

    Secondary Outcome Measures

    1. Overall survival (OS) [Up to 4 years]

    2. Overall response rate (ORR) by investigator [Up to 4 years]

    3. Disease control rate (DCR) by investigator [Up to 4 years]

    4. Duration of response (DoR) by investigator [Up to 4 years]

    5. Time to objective response (TTR) by investigator [Up to 4 years]

    6. Progression Free Survival (PFS) by investigator [Up to 4 years]

    7. Progression free survival secondary objective (PFS2) by investigator [Up to 4 years]

    8. Disease control rate (DCR) by BICR [Up to 4 years]

    9. Duration of response (DoR) by BICR [Up to 4 years]

    10. Time to objective response (TTR) by BICR [Up to 4 years]

    11. Incidence of Adverse Events (AEs) [Up to 4 years]

    12. Incidence of drug-related AEs [Up to 4 years]

    13. Incidence of Severe Adverse Events (SAEs) [Up to 4 years]

    14. Incidence of drug-related SAEs [Up to 4 years]

    15. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 4 years]

    16. Incidence of clinically significant changes in clinical laboratory results: Coagulation tests [Up to 4 years]

    17. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 4 years]

    18. Incidence of clinically significant changes in clinical laboratory results: Serology tests [Up to 4 years]

    19. PFS based on gene expression (GEP) signatures [Up to 4 years]

    20. Objective response rate (ORR) based on GEP signatures [Up to 4 years]

    21. OS based on GEP signatures [Up to 4 years]

    22. OS based on programmed cell death protein ligand-1 (PD-L1) expression [Up to 4 years]

    23. ORR by BICR based on PD-L1 expression [Up to 4 years]

    24. PFS by BICR based on PD-L1 expression [Up to 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Georgetown University Medical Center Washington District of Columbia United States 20007
    2 University Cancer Blood Ctr Athens Georgia United States 30607
    3 Dana Farber Cancer Institute Boston Massachusetts United States 02114
    4 Massachusetts General Hospital Cancer Center Yawkey 7E Boston Massachusetts United States 02114
    5 Massachusetts General Hospital Boston Massachusetts United States 02114
    6 The Reading Hosp Med Ctr Reg Cancer Ctr West Reading Pennsylvania United States 19611
    7 Charleston Hematology Oncology Associates, Pa Charleston South Carolina United States 29414
    8 Local Institution Capital Federal Buenos Aires Argentina 1419
    9 Local Institution Ciudad Autónoma de Buenos Aires Buenos Aires Argentina 1280
    10 Local Institution Mar del Plata Buenos Aires Argentina 7600
    11 Local Institution Rio Cuarto Cordoba Argentina 5800
    12 Local Institution Viedma RIO Negro Argentina 8500
    13 Local Institution Cordoba Argentina X5004FHP
    14 Local Institution San Juan Argentina 5402
    15 Lkh-Univ.Klinikum Graz Graz Austria 8036
    16 Akh Vienna Austria 1090
    17 Klinikum Wels-Grieskirchen Gmbh Wels Austria 4600
    18 Local Institution Santiago de Chile Metropolitana Chile
    19 Local Institution Santiago Metropolitana Chile 8330024
    20 Local Institution Independencia Santiago Chile
    21 Local Institution Vina del Mar Valparaiso Chile 2520598
    22 Local Institution Vina del Mar Valparaiso Chile 2540364
    23 Klinika komplexni onkologicke pece Brno Czechia 656 53
    24 Onkologicko-chirurgicke oddeleni Brno Czechia 656 91
    25 Radioterapeuticka a onkologicka klinika FNKV Praha 10 Czechia 100 34
    26 Onkologicka klinika 1. LF UK a FTN Praha 4 Czechia 140 59
    27 Chu Angers Angers Cedex 10 France 49933
    28 CHRU Jean Minjoz Besançon Cedex France 25030
    29 Hopital Morvan Brest France 29200
    30 Centre Francois Baclesse Caen France 14076
    31 Hôpital Privé Toulon Hyeres Hyeres France 83400
    32 CHU Michallon La Tronche France 38043
    33 Institut Paoli-Calmettes Marseille Cedex 9 France 13273
    34 Polyclinique De Gentilly Nancy France 54100
    35 Centre Antoine Lacassagne Nice France 06189
    36 Institut Mutualiste Montsouris Paris France 75014
    37 Institut De Cancerologie De L Ouest Saint Herblain France 44805
    38 Local Institution Strasbourg France 67200
    39 Hopital Foch Suresnes France 92151
    40 Centre de cancerologie Les Dentellieres Valenciennes France 59300
    41 Institut Gustave Roussy Villejuif France 94800
    42 Athens Medical Center Athens Greece 15125
    43 University General Hospital of Larissa Larissa Greece 41110
    44 Local Institution Arezzo Italy 52100
    45 Local Institution Aviano Pn Italy 33081
    46 Local Institution Brescia Italy 25100
    47 Local Institution Milan Italy 20141
    48 Local Institution Parma Italy 43126
    49 Local Institution Roma Italy 00128
    50 Local Institution Ciudad de Mexico Distrito Federal Mexico 06100
    51 Local Institution Mexico Distrito Federal Mexico 14080
    52 Local Institution Monterrey Nuevo LEON Mexico 64060
    53 Local Institution Chihuahua Mexico 31000
    54 Local Institution Queretaro Mexico 76000
    55 Local Institution Biala Podlaska Poland 21-500
    56 Local Institution Bydgoszcz Poland 85-796
    57 Local Institution Bytom Poland 41-902
    58 Local Institution Gdansk Poland 80-19
    59 Local Institution Poznan Poland 60-569
    60 Local Institution Warszawa Poland 02-781
    61 Local Institution Lisboa Portugal 1649-035
    62 Local Institution Bucharest Romania 020122
    63 Local Institution Cluj-Napoca Romania 400015
    64 Local Institution Craiova Romania 200347
    65 Local Institution Novosibirsk Russian Federation 630099
    66 Local Institution Saint-Petersburg Russian Federation 194044
    67 Local Institution Barcelona Spain 08003
    68 Local Institution Barcelona Spain 08035
    69 Local Institution Cordoba Spain 14004
    70 Local Institution Madrid Spain 28033
    71 Local Institution Madrid Spain 28046
    72 Local Institution Pamplona Spain 31008
    73 Local Institution Sabadell Spain 08208
    74 Local Institution Santander Spain 39008
    75 Local Institution Santiago Compostela Spain 15706
    76 Local Institution Sevilla Spain 41013
    77 Local Institution Valencia Spain 46009

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03873402
    Other Study ID Numbers:
    • CA209-8Y8
    • 2018-004695-35
    First Posted:
    Mar 13, 2019
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Feb 10, 2022