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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/NCT02996110
Registration number
NCT02996110
Ethics application status
Date submitted
15/12/2016
Date registered
19/12/2016
Date last updated
19/12/2022
Titles & IDs
Public title
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
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Scientific title
A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
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Secondary ID [1]
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2016-003082-26
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Secondary ID [2]
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CA018-005
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Universal Trial Number (UTN)
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Trial acronym
FRACTION-RCC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Condition category
Condition code
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
Other interventions - Relatlimab
Treatment: Drugs - BMS-986205
Treatment: Drugs - BMS-813160
Active Comparator: Nivolumab + Ipilimumab - Nivolumab + Ipilimumab
Experimental: Nivolumab + Relatlimab - Nivolumab + Relatlimab
Experimental: Nivolumab + BMS-986205 - Nivolumab + BMS-986205
Experimental: Nivolumab + BMS-813160 - Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
Other interventions: Nivolumab
Specified Dose on Specified Days
Other interventions: Ipilimumab
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Other interventions: Relatlimab
Specified Dose on Specified Days
Treatment: Drugs: BMS-986205
Specified Dose on Specified Days
Treatment: Drugs: BMS-813160
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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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Objective Response Rate (ORR) Per Investigator
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Assessment method [1]
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ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm.
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.
CR+PR, confidence interval based on Clopper and Pearson method.
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Timepoint [1]
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From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
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Primary outcome [2]
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Median Duration of Response (DOR) Per Investigator
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Assessment method [2]
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Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.
Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Median computed using Kaplan -Meier method
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Timepoint [2]
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From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)
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Primary outcome [3]
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Progression Free Survival Rate (PFSR) at 24 Weeks.
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Assessment method [3]
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The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula
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Timepoint [3]
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24 weeks after first treatment dose.
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Secondary outcome [1]
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Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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Timepoint [1]
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From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
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Secondary outcome [2]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [2]
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Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
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Timepoint [2]
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From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
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Secondary outcome [3]
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Number of Participants With Adverse Events (AEs) Leading to Discontinuation
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Assessment method [3]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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Timepoint [3]
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From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
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Secondary outcome [4]
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Number of Participants Who Died
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Assessment method [4]
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Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
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Timepoint [4]
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From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
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Secondary outcome [5]
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Number of Participants With Abnormal Thyroid Test Results - Track 1
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Assessment method [5]
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The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
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Timepoint [5]
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From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
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Secondary outcome [6]
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Number of Participants With Abnormal Thyroid Test Results - Track 2
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Assessment method [6]
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The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
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Timepoint [6]
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From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
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Secondary outcome [7]
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Number of Participants With Abnormal Hepatic Test Results - Track 1
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Assessment method [7]
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The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
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Timepoint [7]
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From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
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Secondary outcome [8]
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Number of Participants With Abnormal Hepatic Test Results - Track 2
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Assessment method [8]
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The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
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Timepoint [8]
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From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
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Eligibility
Key inclusion criteria
- Advanced Renal Cell Carcinoma
- Must have at least 1 lesion with measurable disease
- Life expectancy of at least 3 months
- Karnofsky Performance Status (KPS) must be =>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
- Patients/subjects with suspected or known central nervous system metastases unless
adequately treated
- Patients/subjects with autoimmune disease
- Patients/subjects who need daily oxygen therapy
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 2
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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
2/02/2017
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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
23/11/2021
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Sample size
Target
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Accrual to date
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Final
182
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - 0032 - Westmead
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Recruitment hospital [2]
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Monash Medical Centre Clayton - Bentleigh
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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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3165 - Bentleigh
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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Florida
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United States of America
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Georgia
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Country [4]
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United States of America
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Illinois
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Country [5]
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United States of America
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Maryland
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Massachusetts
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Michigan
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Missouri
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Oregon
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South Carolina
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Tennessee
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Texas
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Washington
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Austria
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Oberösterreich
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Canada
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Ontario
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Canada
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Quebec
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Israel
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Haifa
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Israel
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Ramat Gan
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Italy
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Milano
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Italy
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Napoli
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to test the effectiveness and safety of various nivolumab
combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02996110
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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 public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02996110
Download to PDF