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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02231749
Registration number
NCT02231749
Ethics application status
Date submitted
1/09/2014
Date registered
4/09/2014
Date last updated
15/11/2023
Titles & IDs
Public title
Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
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Scientific 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
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Secondary ID [1]
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2014-001750-42
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Secondary ID [2]
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CA209-214
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Renal Cell Carcinoma
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Metastatic Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Treatment: Drugs - Sunitinib
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
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
Other interventions: Nivolumab
Other interventions: Ipilimumab
Treatment: Drugs: Sunitinib
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1
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Assessment method [1]
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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
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Timepoint [1]
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From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
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Primary outcome [2]
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Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
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Assessment method [2]
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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.
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Timepoint [2]
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From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)
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Primary outcome [3]
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Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
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Assessment method [3]
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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.
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Timepoint [3]
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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)
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Secondary outcome [1]
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Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1
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Assessment method [1]
0
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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
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Timepoint [1]
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From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
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Secondary outcome [2]
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Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
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Assessment method [2]
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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.
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Timepoint [2]
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From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)
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Secondary outcome [3]
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Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
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Assessment method [3]
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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.
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Timepoint [3]
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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)
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
- 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/08/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
1390
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0073 - Kogarah
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Local Institution - 0070 - Westmead
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Local Institution - 0076 - Herston
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Local Institution - 0074 - Murdoch
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2217 - Kogarah
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2145 - Westmead
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4029 - Herston
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4215 - Southport
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5112 - Elizabeth Vale
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3128 - Box Hill
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3168 - Clayton
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment postcode(s) [9]
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6150 - Murdoch
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Recruitment outside Australia
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0
Kanagawa
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Country [103]
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0
Japan
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State/province [103]
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0
Kumamoto
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Country [104]
0
0
Japan
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State/province [104]
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0
Kyoto
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Country [105]
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0
Japan
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State/province [105]
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0
Niigata
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Country [106]
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0
Japan
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State/province [106]
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Okayama
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Country [107]
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0
Japan
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State/province [107]
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Osaka
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Country [108]
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Japan
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State/province [108]
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Shizuoka
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Country [109]
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0
Japan
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State/province [109]
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Tokushima
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Country [110]
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0
Japan
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State/province [110]
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Tokyo
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Country [111]
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0
Japan
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State/province [111]
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0
Yamagata
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Country [112]
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0
Korea, Republic of
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State/province [112]
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Seoul
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Country [113]
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0
Mexico
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State/province [113]
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Distrito Federal
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Country [114]
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Mexico
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State/province [114]
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Nuevo Leon
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Country [115]
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Mexico
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State/province [115]
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Querétaro
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Country [116]
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Mexico
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State/province [116]
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Oaxaca
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Country [117]
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Netherlands
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State/province [117]
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Amsterdam
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Country [118]
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Netherlands
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State/province [118]
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Groningen
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Country [119]
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Netherlands
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State/province [119]
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Nijmegen
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Country [120]
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Poland
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State/province [120]
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Krakow
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Country [121]
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Poland
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State/province [121]
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Poznan
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Country [122]
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Poland
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State/province [122]
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Wroclaw
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Country [123]
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0
Spain
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State/province [123]
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Barcelona
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Country [124]
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Spain
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State/province [124]
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Madrid
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Country [125]
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Spain
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State/province [125]
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Oviedo
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Country [126]
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Spain
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State/province [126]
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Sevilla
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Country [127]
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Sweden
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State/province [127]
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Solna
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Country [128]
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Taiwan
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State/province [128]
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Taipei
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Country [129]
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Taiwan
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State/province [129]
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Taoyuan
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Country [130]
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Turkey
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State/province [130]
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Ankara
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Country [131]
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Turkey
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State/province [131]
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Antalya
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Country [132]
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Turkey
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State/province [132]
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Istanbul
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Country [133]
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United Kingdom
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State/province [133]
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0
Greater London
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Country [134]
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United Kingdom
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State/province [134]
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0
Lanarkshire
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Country [135]
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United Kingdom
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State/province [135]
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London
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Country [136]
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United Kingdom
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State/province [136]
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Manchester
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Country [137]
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United Kingdom
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State/province [137]
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Northwood
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Country [138]
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United Kingdom
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State/province [138]
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/Industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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Address [1]
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0
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02231749
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02231749
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