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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/NCT04209114
Registration number
NCT04209114
Ethics application status
Date submitted
20/12/2019
Date registered
23/12/2019
Date last updated
12/10/2023
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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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
Other interventions - Nivolumab
Treatment: Surgery - Radical cystectomy (RC)
Other interventions - 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
Other interventions: Nivolumab
Specified dose on specified days
Treatment: Surgery: Radical cystectomy (RC)
Surgical removal of the bladder
Other interventions: Bempegaldesleukin
Specified dose on specified days
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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: 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 of Arm A to Arm C
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Assessment method [1]
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Timepoint [1]
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Approximately 43 months
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Primary outcome [2]
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Event-Free Survival (EFS) of Arm A vs Arm C
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Assessment method [2]
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Timepoint [2]
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Approximately 43 months
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Secondary outcome [1]
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pCR rate of Arm B to Arm C
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Assessment method [1]
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Timepoint [1]
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Approximately 43 months
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Secondary outcome [2]
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EFS of Arm B vs Arm C
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Assessment method [2]
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Timepoint [2]
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Approximately 43 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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Timepoint [3]
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Approximately 43 months
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Secondary outcome [4]
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Incidence of Adverse Events (AEs)
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Assessment method [4]
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Timepoint [4]
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Up to 76.5 weeks
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Secondary outcome [5]
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Incidence of Serious Adverse Events (SAEs)
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Assessment method [5]
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Timepoint [5]
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Up to 76.5 weeks
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Secondary outcome [6]
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Incidence of AEs leading to discontinuation
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Assessment method [6]
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Timepoint [6]
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Up to 76.5 weeks
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Secondary outcome [7]
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Incidence of immune-mediated AEs (imAEs)
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Assessment method [7]
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Timepoint [7]
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Up to 76.5 weeks
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Secondary outcome [8]
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Incidence of participants with clinical laboratory abnormalities
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Assessment method [8]
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Timepoint [8]
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Up to 76.5 weeks
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Secondary outcome [9]
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pCR rate of Arm A to Arm B
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Assessment method [9]
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Timepoint [9]
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Approximately 43 months
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Secondary outcome [10]
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EFS of Arm A vs Arm B
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Assessment method [10]
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Timepoint [10]
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Approximately 43 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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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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Local Institution - 0158 - Ballarat
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Local Institution - 0157 - Fitzroy
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Local Institution - 0011 - Heidelberg
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Local Institution - 0013 - Murdoch
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2250 - Gosford
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3350 - Ballarat
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3065 - Fitzroy
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3084 - Heidelberg
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6150 - Murdoch
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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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Address
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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/ct2/show/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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04209114
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