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Trial record 1 of 1 for:    CA209-214
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Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02231749
Recruitment Status : Active, not recruiting
First Posted : September 4, 2014
Results First Posted : October 16, 2018
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

Condition or disease Intervention/treatment Phase
Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Biological: Nivolumab Biological: Ipilimumab Drug: Sunitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : June 26, 2017
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Experimental: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Other Name: Yervoy

Active Comparator: Arm B: Sunitinib 50 mg

Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks

Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Other Name: Yervoy

Drug: Sunitinib
Other Name: Sutent




Primary Outcome Measures :
  1. Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 [ Time Frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months) ]
    ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  2. Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) [ Time Frame: From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months) ]
    OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.

  3. Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) [ Time Frame: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months) ]
    PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.


Secondary Outcome Measures :
  1. Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1 [ Time Frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months) ]
    ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  2. Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) [ Time Frame: From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months) ]
    Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.

  3. Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) [ Time Frame: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months) ]
    PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
  • No prior systemic therapy for RCC with the following exception:

    1. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

      • Karnofsky Performance Status (KPS) of at least 70%
      • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
      • Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone metastases samples are not acceptable for submission)

Exclusion Criteria:

  • Any history of or current central nervous system (CNS) metastases. Baseline imaging of the brain is required within 28 days prior to randomization
  • Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)
  • Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
  • Any condition requiring systemic treatment with corticosteroids (>10 mg daily Prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10 mg daily Prednisone equivalents are permitted in the absence of active autoimmune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231749


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Locations
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United States, California
City Of Hope
Duarte, California, United States, 91010
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0698
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Connecticut
Smilow Cancer Hospital. At Yale New Haven
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute.
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University Of Kansas Cancer Center
Fairway, Kansas, United States, 66205
United States, Maryland
Uof Md,Greenebaum Cancer Ctr.
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Beth Isr. Deacon. Med Cnt
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Erlanger Oncology & Hematology - Univ. of TN
Chattanooga, Tennessee, United States, 37403
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9113
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Argentina
COIBA
Berazategui, Buenos Aires, Argentina, 1880
Local Institution
Capital Federal, Buenos Aires, Argentina, 1431
Hospital Italiano De Buenos Aires
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
Centro Medico San Roque
San Miguel de Tucuman, Tucuman, Argentina, 4000
Centro Para La Atencion Integral Del Paciente Oncologico
San Miguel De Tucuman, Tucuman, Argentina, 4000
Instituto Medico Especialazado Alexander Fleming
Caba, Argentina, 1426
Instituto Oncologico De Cordoba
Cordoba, Argentina, 5000
Australia, New South Wales
Local Institution
Kogarah, New South Wales, Australia, 2217
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Local Institution
Herston, Queensland, Australia, 4029
Local Institution
Southport, Queensland, Australia, 4215
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Clayton, Victoria, Australia, 3168
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Australia
Local Institution
Elizabeth Vale, Australia, 5112
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Murdoch, Australia, 6150
Austria
Local Institution
Linz, Austria, 4020
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Vienna, Austria, 1090
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Wels, Austria, 4600
Belgium
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil, 30130-090
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Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
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Porto Alegre, RIO Grande DO SUL, Brazil, 91610-000
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Rio de Janeiro, Brazil, 22793-080
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Sao Paulo, Brazil, 01323-010
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Sao Paulo, Brazil, 01406-100
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Sao Paulo, Brazil, 01509-900
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Chile
Centro De Cancer, Pontificia Universidad Catolica
Santiago, Metropolitana, Chile
Fundacion Arturo Lopez Perez
Santiago, Metropolitana, Chile
Centro Internacional de Estudios Clinicos
Recoleta, Santiago DE Chile, Chile
Instituto Oncologico
Vina del Mar, Chile, 254 0364
Colombia
Local Institution
Bogota, Colombia
Hospital Pablo Tobon Uribe
Medellin, Colombia, MEDELLIN
Instituto de Cancerologia SA
Medellin, Colombia
Czechia
Local Institution
Brno, Czechia, 656 53
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Hradec Kralove, Czechia, 500 05
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Liberec, Czechia, 460 63
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Olomouc, Czechia, 779 00
Denmark
Aarhus Universitetshospital
Aarhus N, Denmark, 8200
Herlev University Hospital
Herlev, Denmark, 2730
Local Institution
Odense, Denmark, 5000
Finland
Helsinki University Hospital
Helsinki, Finland, 00029
Tampere University Hospital
Tampere, Finland, 33521
France
CHU Hopital Jean Minjoz
Besancon, France, 25030
Local Institution
Bordeaux, France, 33075
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La Roche sur Yon, France, 85320
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Marseille Cedex 9, France, 13273
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Paris, France, 75015
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Saint Herblain, France, 44805
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Strasbourg, France, 67091
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Toulouse Cedex 9, France, 31059
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Villejuif, France, 94805
Germany
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Aachen, Germany, 52074
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Erlangen, Germany, 91054
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Frankfurt, Germany, 60590
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Hamburg, Germany, 20246
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Homburg, Germany, 66424
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Jena, Germany, 07747
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Magdeburg, Germany, 39120
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Muenchen, Germany, 81675
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Muenster, Germany, 48149
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Ulm, Germany, 89075
Hungary
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Budapest, Hungary, 1122
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Debrecen, Hungary, 4032
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Gyula, Hungary, 5700
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Pecs, Hungary, 7624
Ireland
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Wilton, Cork, Ireland
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Dublin 7, Dublin, Ireland
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Dublin, Ireland, 24
Israel
Local Institution
Beer Jacob, Israel, 70300
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Haifa, Israel, 31096
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Kfar Saba, Israel, 44281
Local Institution
Petach Tikva, Israel, 49100
Local Institution
Ramat-gan, Israel, 52621
Italy
Ospedal S. Donato Usl 8
Arezzo, Italy, 52100
Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori
Meldola (fc), Italy, 47014
Local Institution
Milano, Italy, 20133
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Napoli, Italy, 80131
Istituto Oncologico Veneto IOV
Padova, Italy, 35128
Local Institution
Pavia, Italy, 27100
Local Institution
Roma, Italy, 00149
Japan
Local Institution
Akita-shi, Akita, Japan, 010-8542
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Hirosaki-shi, Aomori, Japan, 036-8563
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Chiba-shi, Chiba, Japan, 260-8717
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Fukuoka-shi, Fukuoka, Japan, 8128582
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Sapporo-shi, Hokai-do, Japan, 060-8543
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Sapporo-shi, Hokkaido, Japan, 0608648
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Kobe-shi, Hyogo, Japan, 650-0017
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Tsukuba-shi, Ibaraki, Japan, 3058576
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Morioka-shi, Iwate, Japan, 0208505
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Yokohama-shi, Kanagawa, Japan, 2360004
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Kumamoto-shi, Kumamoto, Japan, 8608556
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Kyoto-shi, Kyoto, Japan, 6028566
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Niigata-shi, Niigata, Japan, 9518520
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Okayama-shi, Okayama, Japan, 7008558
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Osaka-sayama, Osaka, Japan, 589-8511
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Suita-shi, Osaka, Japan, 5650871
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Hamamatsu-shi, Shizuoka, Japan, 4313192
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Tokushima-shi, Tokushima, Japan, 770-8503
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Bunkyo-ku, Tokyo, Japan, 113-8603
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Bunkyo-ku, Tokyo, Japan, 1138431
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Bunkyo-ku, Tokyo, Japan, 1138519
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Bunkyo-ku, Tokyo, Japan, 1138655
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Koto-ku, Tokyo, Japan, 1358550
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Shinjuku-Ku, Tokyo, Japan, 1608582
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Yamagata-shi, Yamagata, Japan, 9909585
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Tokyo, Japan, 1628666
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 03080
Local Institution
Seoul, Korea, Republic of, 03722
Local Institution
Seoul, Korea, Republic of, 05505
Mexico
Local Institution
Mexico D.f., Distrito Federal, Mexico, 14050
Local Institution
Monterrey, Nuevo LEON, Mexico, 64460
Local Institution
Santiago de Queretaro, Queretaro, Mexico, 76090
Local Institution
Oaxaca, Mexico, 68000
Netherlands
Local Institution
Amsterdam, Netherlands, 1066 CX
Local Institution
Groningen, Netherlands, 9713 GZ
Local Institution
Nijmegen, Netherlands, 6525 GA
Poland
Local Institution
Krakow, Poland, 31-115
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Poznan, Poland, 60-569
Local Institution
Wroclaw, Poland, 50-556
Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain, 08025
H. Univ. Vall dHebron
Barcelona, Spain, 08035
Hospital Ramon Y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hosp Univer 12 De Octubre
Madrid, Spain, 28041
Hospital General De Asturias
Oviedo, Spain, 33011
Hosp. Univ. Virgen Del Rocio
Sevilla, Spain, 41013
Sweden
Karolinska University Hospital
Solna, Sweden, 171 64
Taiwan
Local Institution
Taipei, Taiwan, 100
Local Institution
Taipei, Taiwan, 112
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Taoyuan, Taiwan, 333
Turkey
Local Institution
Ankara, Turkey, TR-06100
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Antalya, Turkey, 07070
Local Institution
Istanbul, Turkey, 34890
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW3 6JJ
Local Institution
Glasgow, Lanarkshire, United Kingdom, G12 0YN
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London, United Kingdom, EC1A 7BE
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Manchester, United Kingdom, M20 4BX
Local Institution
Northwood, United Kingdom, HA6 2RN
Local Institution
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] September 1, 2016
Study Protocol  [PDF] November 13, 2017


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02231749     History of Changes
Other Study ID Numbers: CA209-214
2014-001750-42 ( EudraCT Number )
First Posted: September 4, 2014    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: July 15, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Sunitinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action