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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04810078
Registration number
NCT04810078
Ethics application status
Date submitted
16/03/2021
Date registered
22/03/2021
Date last updated
25/07/2024
Titles & IDs
Public title
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
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Scientific title
A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
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Secondary ID [1]
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0
2020-003655-15
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Secondary ID [2]
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CA209-67T
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Universal Trial Number (UTN)
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Trial acronym
CheckMate-67T
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clear Cell Renal Cell Carcinoma
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0
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Condition category
Condition code
Cancer
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0
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0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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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
Treatment: Other - Nivolumab and rHuPH20
Treatment: Other - Nivolumab
Experimental: Arm A -
Active comparator: Arm B -
Experimental: Arm C -
Experimental: Arm D -
Treatment: Other: Nivolumab and rHuPH20
Specified dose on specified days
Treatment: Other: Nivolumab
Specified dose on specified days
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Intervention code [1]
0
0
Treatment: Other
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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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Time-averaged serum concentration over 28 days (Cavgd28)
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Assessment method [1]
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0
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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0
Trough serum concentration at steady-state (Cminss)
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Assessment method [2]
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0
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Timepoint [2]
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Up to 4 months
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Secondary outcome [1]
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0
Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up
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Assessment method [1]
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0
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Timepoint [1]
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0
Up to 2 years 6 months
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Secondary outcome [2]
0
0
Trough serum concentration at day 28 (Cmind28)
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Assessment method [2]
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0
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Timepoint [2]
0
0
At 28 days
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Secondary outcome [3]
0
0
Maximum serum concentration after the first dose (Cmax1)
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Assessment method [3]
0
0
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Timepoint [3]
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0
Up to 7 days
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Secondary outcome [4]
0
0
Peak serum concentration at steady-state (Cmaxss)
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Assessment method [4]
0
0
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Timepoint [4]
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0
Up to 4 months
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Secondary outcome [5]
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0
Steady-state average serum concentration (Cavgss)
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Assessment method [5]
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0
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Timepoint [5]
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0
Up to 4 months
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Secondary outcome [6]
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0
Trough concentration (Ctrough)
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Assessment method [6]
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0
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Timepoint [6]
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0
At week 17
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Secondary outcome [7]
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Incidence of adverse events (AEs)
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Assessment method [7]
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0
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Timepoint [7]
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0
Up to 2 years 3 months
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Secondary outcome [8]
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0
Incidence of serious adverse events (SAEs)
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Assessment method [8]
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0
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Timepoint [8]
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0
Up to 2 years 3 months
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Secondary outcome [9]
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0
Incidence of AEs leading to discontinuation
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Assessment method [9]
0
0
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Timepoint [9]
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0
Up to 2 years
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Secondary outcome [10]
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0
Incidence of deaths
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Assessment method [10]
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0
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Timepoint [10]
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0
Up to 5 years
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Secondary outcome [11]
0
0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
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Assessment method [11]
0
0
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Timepoint [11]
0
0
Up to 2 years 3 months
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Secondary outcome [12]
0
0
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Up to 2 years 3 months
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Secondary outcome [13]
0
0
Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up
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Assessment method [13]
0
0
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Timepoint [13]
0
0
Up to 2 years 6 months
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Secondary outcome [14]
0
0
Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up
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Assessment method [14]
0
0
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Timepoint [14]
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Up to 3 years
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Secondary outcome [15]
0
0
Efficacy parameters: DCR by BICR at end of study
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Assessment method [15]
0
0
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Timepoint [15]
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Up to 5 years
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Secondary outcome [16]
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0
Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up
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Assessment method [16]
0
0
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Timepoint [16]
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Up to 2 years 6 months
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Secondary outcome [17]
0
0
Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up
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Assessment method [17]
0
0
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Timepoint [17]
0
0
Up to 3 years
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Secondary outcome [18]
0
0
Efficacy parameters: DOR by BICR at end of study
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Assessment method [18]
0
0
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Timepoint [18]
0
0
Up to 5 years
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Secondary outcome [19]
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0
Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up
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Assessment method [19]
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0
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Timepoint [19]
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Up to 2 years 6 months
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Secondary outcome [20]
0
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Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up
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Assessment method [20]
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0
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Timepoint [20]
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Up to 3 years
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Secondary outcome [21]
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Efficacy parameters: TTR by BICR at end of study
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Assessment method [21]
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0
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Timepoint [21]
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Up to 5 years
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Secondary outcome [22]
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Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up
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Assessment method [22]
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0
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Timepoint [22]
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Up to 2 years 6 months
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Secondary outcome [23]
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0
Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up
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Assessment method [23]
0
0
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Timepoint [23]
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Up to 3 years
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Secondary outcome [24]
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Efficacy parameters: PFS by BICR at end of study
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Assessment method [24]
0
0
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Timepoint [24]
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Up to 5 years
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Secondary outcome [25]
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Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up
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Assessment method [25]
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0
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Timepoint [25]
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Up to 2 years 6 months
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Secondary outcome [26]
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Efficacy parameters: OS with a minimum of 12 months follow-up
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Assessment method [26]
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0
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Timepoint [26]
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Up to 3 years
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Secondary outcome [27]
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Efficacy parameters: OS at end of study
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Assessment method [27]
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0
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Timepoint [27]
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Up to 5 years
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Secondary outcome [28]
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Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up
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Assessment method [28]
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0
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Timepoint [28]
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Up to 3 years
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Secondary outcome [29]
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Efficacy parameters: ORR by BICR at end of study
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Assessment method [29]
0
0
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Timepoint [29]
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Up to 5 years
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Secondary outcome [30]
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Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions/systemic injection reactions
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Assessment method [30]
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Timepoint [30]
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Up to 2 years 3 months
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Secondary outcome [31]
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Incidence of local injection- or infusion-site reactions
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Assessment method [31]
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0
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Timepoint [31]
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Up to 2 years 3 months
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Secondary outcome [32]
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Percentage of participants who develop anti-nivolumab antibodies, if applicable
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Assessment method [32]
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0
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Timepoint [32]
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Up to 2 years 3 months
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Secondary outcome [33]
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Percentage of participants who develop neutralizing antibodies, if applicable
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Assessment method [33]
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0
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Timepoint [33]
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Up to 2 years 3 months
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
* Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
* Received no more than 2 prior systemic treatment regimens
* Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization
* Karnofsky PS = 70 at screening
* Must agree to follow specific methods of contraception, if applicable
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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
* Untreated, symptomatic central nervous system (CNS) metastases
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization
* Active, known, or suspected autoimmune disease
* Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/µL. Participants with HIV are eligible if:
1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
2. They continue on ART as clinically indicated while enrolled on study
3. CD4 counts and viral load are monitored per standard of care by a local health care provider
4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally
* Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible
* Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
* Treatment with any live attenuated vaccine within 30 days of first study treatment
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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
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
24/05/2021
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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
29/01/2026
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Actual
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Sample size
Target
632
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Illinois
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United States of America
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New York
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United States of America
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Pennsylvania
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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RIO Negro
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Argentina
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San Juan
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Brazil
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Parana
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Brazil
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RIO Grande DO SUL
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Chile
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Araucania
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Chile
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Metropolitana
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Valparaiso
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Brno
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Olomouc
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Ostrava
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Jyvaskyla
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Lyon
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France
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Nice cedex 2
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Izmir
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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 evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
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Trial website
https://clinicaltrials.gov/study/NCT04810078
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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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Bristol-Myers Squibb
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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855-907-3286
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[email protected]
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Contact person for scientific queries
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Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT04810078
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