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Trial record 1 of 1 for:    NCT04209114
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A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has 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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ClinicalTrials.gov Identifier: NCT04209114
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 20, 2019
First Posted Date  ICMJE December 23, 2019
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE February 5, 2020
Estimated Primary Completion Date August 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2020)
  • Pathologic complete response (pCR) rate of neoadjuvant nivolumab + bempeg to Standard of Care (SOC) in all randomized participants [ Time Frame: Approximately 36 months ]
  • Event-free survival (EFS) of neoadjuvant nivolumab + bempeg followed by adjuvant nivolumab + bempeg after RC vs. SOC [ Time Frame: Approximately 54 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • Pathologic complete response (pCR) rate of neoadjuvant nivolumab + NKTR-214 to Standard of Care (SOC) in all randomized participants [ Time Frame: Approximately 36 months ]
  • Event-free survival (EFS) of neoadjuvant nivolumab + NKTR-214 followed by adjuvant nivolumab + NKTR-214 after RC vs. SOC [ Time Frame: Approximately 54 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • pCR rate of neoadjuvant nivolumab monotherapy to SOC at the time of surgery in all randomized participants [ Time Frame: Approximately 36 months ]
  • EFS of neoadjuvant nivolumab followed by adjuvant nivolumab vs. SOC [ Time Frame: Approximately 54 months ]
  • Overall survival [ Time Frame: Approximately 74 months ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to 5 years ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 5 years ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
  • Incidence of immune-mediated AEs (imAEs) [ Time Frame: Up to 5 years ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has Invaded the Muscle Wall of the Bladder and Who Cannot Get Cisplatin, a Type of Medicine Given to Treat Bladder Cancer.
Official Title  ICMJE A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible
Brief Summary The purpose of the study is to see if treatment with nivolumab plus bempeg or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Bladder Tumor
  • Muscle-Invasive Bladder Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Name: Opdivo
  • Biological: Bempeg
    Specified dose on specified days
    Other Name: BMS-986321, NKTR-214
  • Procedure: Radical cystectomy (RC)
    Surgical removal of the bladder
Study Arms  ICMJE
  • Experimental: Combination
    Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg
    Interventions:
    • Biological: Nivolumab
    • Biological: Bempeg
    • Procedure: Radical cystectomy (RC)
  • Experimental: Monotherapy
    Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab
    Interventions:
    • Biological: Nivolumab
    • Procedure: Radical cystectomy (RC)
  • Standard-of-care
    RC alone, without neoadjuvant or adjuvant therapy
    Intervention: Procedure: Radical cystectomy (RC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2019)
540
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 5, 2024
Estimated Primary Completion Date August 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder tumor (TURBT) and confirmed by radiographic imaging.
  • 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%
  • Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Clinical evidence of pathologic lymph node (LN) 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

Other protocol-defined inclusion/exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04209114
Other Study ID Numbers  ICMJE CA045-009
2018-002676-40 ( EudraCT Number )
18-214-13 ( Other Identifier: Nektar Therapeutics )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Nektar Therapeutics
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP