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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/NCT01668784
Registration number
NCT01668784
Ethics application status
Date submitted
16/08/2012
Date registered
20/08/2012
Date last updated
9/08/2022
Titles & IDs
Public title
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
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Scientific title
A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
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Secondary ID [1]
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2011-005132-26
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Secondary ID [2]
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CA209-025
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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 or Metastatic (Medically or Surgically Unresectable) Clear-cell 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(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Treatment: Drugs - Everolimus
Experimental: Arm 1: Nivolumab - Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Active Comparator: Arm 2: Everolimus - Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Other interventions: Nivolumab
Treatment: Drugs: Everolimus
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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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Overall Survival (OS) at Primary Endpoint
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Assessment method [1]
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Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p < 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.
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Timepoint [1]
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Randomization until 398 deaths, up to May 2015 (approximately 30 months)
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Secondary outcome [1]
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Investigator-assessed Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.
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Timepoint [1]
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from randomization up to disease progression or death (approximately up to 105 Months)
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Secondary outcome [2]
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Investigator-assessed Duration of Objective Response
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Assessment method [2]
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Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.
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Timepoint [2]
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From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)
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Secondary outcome [3]
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Investigator-assessed Time to Objective Response
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Assessment method [3]
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Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.
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Timepoint [3]
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Randomization to date of first response (approximately 105 months)
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Secondary outcome [4]
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Investigator-assessed Time of Progression-free Survival (PFS)
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Assessment method [4]
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PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: >=20% increase in sum of target lesion diameters and sum must show absolute increase of >=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.
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Timepoint [4]
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from randomization up to disease progression or death (approximately up to 105 Months)
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Secondary outcome [5]
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Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level
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Assessment method [5]
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Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&E process before the tumor biopsy specimen was sent for evaluation or from H&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.
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Timepoint [5]
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Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)
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Secondary outcome [6]
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Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events
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Assessment method [6]
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Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Timepoint [6]
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Day of first dose to 30 days post study completion (approximately 106 months)
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Secondary outcome [7]
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Percentage of Participants With Disease-related Symptom Progression (DRSP)
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Assessment method [7]
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Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.
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Timepoint [7]
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from randomization up to disease progression or death (approximately up to 105 Months)
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Secondary outcome [8]
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Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests
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Assessment method [8]
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Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).
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Timepoint [8]
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Day 1 to 30 days post study completion (approximately 106 months)
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Secondary outcome [9]
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Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units
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Assessment method [9]
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Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: < 8.0 g/dL), Platelet Count (Gr 3: 25.0 -< 50.0*10^9 c/L; Gr 4: < 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -< 2.0*10^3 c/µL; Gr4: < 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -< 0.5*10^3 c/µL; Gr 4: < 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - < 1.0*10^3 c/µL; Gr 4: < 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), AST (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), ALT (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), tBIL (Gr 3: > 3.0 - 10.0 mg/dL * ULN; Gr 4: > 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: > 3.0 - 6.0 mg/dL *ULN; Gr4: > 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).
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Timepoint [9]
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Day 1 to 30 days post study completion (approximately 106 months)
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Eligibility
Key inclusion criteria
- Men & women =18 years of age
- Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
- Advanced/metastatic RCC
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
criteria
- Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic
setting
- No more than 3 total prior systemic treatment regimens in the advanced or metastatic
setting, and evidence of progression on or after last treatment regimen received and
within 6 months of enrollment
- Karnofsky Performance Score =70%
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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 Central Nervous System (CNS) metastases or history of CNS metastases
- Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
- Any active known or suspected autoimmune disease
- Uncontrolled adrenal insufficiency
- Active chronic liver disease
- Prior malignancy active within past 3 years, except for locally curable cancers
Other protocol-defined inclusion/exclusion criteria apply
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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
Completed
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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
9/10/2012
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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
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Actual
19/07/2021
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Sample size
Target
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Accrual to date
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Final
821
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Local Institution - 0095 - Westmead
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Recruitment hospital [2]
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Local Institution - Woodville South
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Recruitment hospital [3]
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Local Institution - Box Hill
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Recruitment hospital [4]
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Local Institution - Clayton
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Recruitment hospital [5]
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Local Institution - Melbourne
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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Arkansas
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California
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Colorado
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District of Columbia
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Arezzo
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Meldola (fc)
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Milano
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Italy
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Rimini
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Terni
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Akita
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Chiba
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Fukuoka
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Kanagawa
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Japan
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State/province [87]
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Kyoto
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Country [88]
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Japan
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Osaka
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Country [89]
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Japan
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Shizuoka
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Country [90]
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Japan
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State/province [90]
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Tokushima
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Country [91]
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Japan
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State/province [91]
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Yamagata
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Country [92]
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Japan
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State/province [92]
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Kobe-city, Hyogo
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Country [93]
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Japan
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State/province [93]
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Kumamoto
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Country [94]
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Japan
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State/province [94]
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Tokyo
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Country [95]
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Norway
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State/province [95]
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0
Bergen
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Country [96]
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Norway
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State/province [96]
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Lorenskog
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Country [97]
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Poland
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State/province [97]
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Gdansk
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Country [98]
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Poland
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State/province [98]
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Lodz
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Country [99]
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Poland
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State/province [99]
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Poznan
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Country [100]
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Poland
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State/province [100]
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Rybnik
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Country [101]
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Poland
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State/province [101]
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Warszawa
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Country [102]
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Poland
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State/province [102]
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Wroclaw
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Country [103]
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Romania
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State/province [103]
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Bucharest
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Country [104]
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Romania
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State/province [104]
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Craiova
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Country [105]
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Romania
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State/province [105]
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Iasi
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Country [106]
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Romania
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State/province [106]
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Timisoara
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Country [107]
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Russian Federation
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State/province [107]
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Moscow
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Country [108]
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Russian Federation
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State/province [108]
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St Petersburg
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Country [109]
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Spain
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State/province [109]
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Navarra
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Country [110]
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Spain
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State/province [110]
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Barcelona
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Country [111]
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Spain
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State/province [111]
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Hospitalet De Llobregat
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Country [112]
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Spain
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State/province [112]
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Madrid
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Country [113]
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Sweden
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State/province [113]
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Gothenberg
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Country [114]
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Sweden
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State/province [114]
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Solna
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Country [115]
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United Kingdom
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State/province [115]
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Cambridgeshire
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Country [116]
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United Kingdom
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State/province [116]
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Carmarthenshire
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Country [117]
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United Kingdom
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State/province [117]
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Greater London
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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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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to compare the clinical benefit, as measured by duration of
overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic
clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01668784
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01668784
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