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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04209114
Registration number
NCT04209114
Ethics application status
Date submitted
20/12/2019
Date registered
23/12/2019
Titles & IDs
Public title
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
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Scientific title
A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible
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Secondary ID [1]
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0
2018-002676-40
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Secondary ID [2]
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CA045-009
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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:
Bladder Cancer
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Bladder Tumor
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Muscle-Invasive Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Surgery - Radical cystectomy (RC)
Treatment: Other - Bempegaldesleukin
Experimental: Arm A: Combination Therapy - Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg
Experimental: Arm B: Monotherapy - Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab
Other: Arm C: Standard-of-care - RC alone, without neoadjuvant or adjuvant therapy
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Surgery: Radical cystectomy (RC)
Surgical removal of the bladder
Treatment: Other: Bempegaldesleukin
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Surgery
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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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Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care
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Assessment method [1]
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Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.
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Timepoint [1]
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From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)
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Primary outcome [2]
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Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care
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Assessment method [2]
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Event Free Survival (EFS) is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence based on blinded independent committee review (BICR) assessments, or death due to any cause.
Participants who did not have an EFS event will be censored on the date of their last evaluable tumor assessment (imaging or biopsy) or at the date of radical surgery whichever occur last. Participants who did not have any baseline tumor assessments (imaging or biopsy) and did not undergo radical cystectomy for other reason than worsening/progression of disease will be censored on their date of randomization. Participants who did not have any on study tumor assessments (imaging or biopsy) and did not die will be censored on their date of radical cystectomy (or randomization date if no radical cystectomy performed).
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Timepoint [2]
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From randomization up to first EFS event (up to approximately 30 months)
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Secondary outcome [1]
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Pathologic Complete Response (pCR) Rate - Nivolumab Compared to Standard of Care
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Assessment method [1]
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Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.
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Timepoint [1]
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From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)
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Secondary outcome [2]
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Event Free Survival (EFS) - Nivolumab Compared to Standard of Care
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Assessment method [2]
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Event Free Survival (EFS) is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence based on blinded independent committee review (BICR) assessments, or death due to any cause.
Participants who did not have an EFS event will be censored on the date of their last evaluable tumor assessment (imaging or biopsy) or at the date of radical surgery whichever occur last. Participants who did not have any baseline tumor assessments (imaging or biopsy) and did not undergo radical cystectomy for other reason than worsening/progression of disease will be censored on their date of randomization. Participants who did not have any on study tumor assessments (imaging or biopsy) and did not die will be censored on their date of radical cystectomy (or randomization date if no radical cystectomy performed).
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Timepoint [2]
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From randomization up to first EFS event (up to approximately 30 months)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
OS was not calculated for Arm A and Arm B because the number of events did not meet the threshold due to early study termination. In lieu of OS, time to death is reported as a Post-Hoc endpoint.
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Timepoint [3]
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From randomization to study completion, up to approximately 40 months
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Secondary outcome [4]
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The Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [4]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
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Timepoint [4]
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from first dose to 100 days following last dose (up to approximately 20 months)
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Secondary outcome [5]
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The Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [5]
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A 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 [5]
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from first dose to 100 days following last dose (up to approximately 20 months)
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Secondary outcome [6]
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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
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Assessment method [6]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
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Timepoint [6]
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from first dose to 100 days following last dose (up to approximately 20 months)
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Secondary outcome [7]
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The Number of Participants Experiencing Immune-Mediated Adverse Events (IMAEs)
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Assessment method [7]
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IMAEs are specific AEs that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis), and other specific events, considered as potential immune-mediated events by investigator that meet the definition summarized below:
* those occurring within 100 days of the last dose,
* regardless of causality,
* treated with immune-modulating medication (of note, endocrine AEs such as adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis are considered IMAEs regardless of immune-modulating medication use, since endocrine drug reactions are often managed without immune-modulating medication).
* with no clear alternate etiology based on investigator assessment, or with an immune-mediated component.
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Timepoint [7]
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0
from first dose to 100 days following last dose (up to approximately 20 months)
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Secondary outcome [8]
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Worst Grade Clinical Laboratory Values
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Assessment method [8]
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Clinical laboratory values by worst CTC grade are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
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Timepoint [8]
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From first dose to 100 days following last dose (up to approximately 20 months)
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Eligibility
Key inclusion criteria
* Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT)
* Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Cisplatin-ineligible participants will be defined by any one of the following criteria:
i) Impaired renal function (glomerular filtration rate [GFR] = 30 but < 60 mL/min) ii) GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii) Common Terminology Criteria for Adverse Events (CTCAE) version 5, = Grade 2 hearing loss (assessed per local SOC).
iv) CTCAE version 5, = Grade 2 peripheral neuropathy.
* Documented Left Ventricular Ejection Fraction (LVEF) more than 45%
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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
* Clinical evidence of = N2 or metastatic bladder cancer
* Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment.
* Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC
* History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic attack) arterial thromboembolic event
* Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias)
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
5/02/2020
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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
7/06/2023
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Sample size
Target
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Accrual to date
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Final
114
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0137 - Gosford
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Recruitment hospital [2]
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Local Institution - 0158 - Ballarat
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Recruitment hospital [3]
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Local Institution - 0157 - Fitzroy
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Recruitment hospital [4]
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Local Institution - 0011 - Heidelberg
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Recruitment hospital [5]
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Local Institution - 0013 - Murdoch
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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3350 - Ballarat
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
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Sevilla
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Country [92]
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United Kingdom
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State/province [92]
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Hertfordshire
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United Kingdom
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Leicester
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United Kingdom
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State/province [94]
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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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Other collaborator category [1]
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Commercial sector/industry
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Nektar Therapeutics
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Ethics approval
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Summary
Brief summary
The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.
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Trial website
https://clinicaltrials.gov/study/NCT04209114
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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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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/14/NCT04209114/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/14/NCT04209114/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04209114