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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.

NCT04209114

Description:

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.

Related Conditions:
  • Bladder Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab Plus 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: 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

Clinical Trial IDs

  • ORG STUDY ID: CA045-009
  • SECONDARY ID: 2018-002676-40
  • SECONDARY ID: 18-214-13
  • NCT ID: NCT04209114

Conditions

  • Bladder Cancer
  • Bladder Tumor
  • Muscle-Invasive Bladder Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivoCombination
NKTR-214BMS-986321Combination

Purpose

The purpose of the study is to see if treatment with nivolumab plus NKTR-214 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.

Trial Arms

NameTypeDescriptionInterventions
CombinationExperimentalNeoadjuvant (pre-surgical treatment) nivolumab + NKTR-214, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + NKTR-214
  • Nivolumab
  • NKTR-214
MonotherapyExperimentalNeoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab
  • Nivolumab
Standard-of-careOtherRC alone, without neoadjuvant or adjuvant therapy

    Eligibility Criteria

            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%
    
            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 or urothelial carcinoma not confined to the
                 bladder.
    
            Other protocol defined inclusion/exclusion criteria could apply
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Pathologic complete response (pCR) rate of neoadjuvant nivolumab + NKTR-214 to Standard of Care (SOC) in all randomized participants
    Time Frame:Approximately 36 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:pCR rate of neoadjuvant nivolumab monotherapy to SOC at the time of surgery in all randomized participants
    Time Frame:Approximately 36 months
    Safety Issue:
    Description:
    Measure:EFS of neoadjuvant nivolumab followed by adjuvant nivolumab vs. SOC
    Time Frame:Approximately 54 months
    Safety Issue:
    Description:
    Measure:Overall survival
    Time Frame:Approximately 74 months
    Safety Issue:
    Description:
    Measure:Incidence of adverse events (AEs)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of serious adverse events (SAEs)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of AEs leading to discontinuation
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of immune-mediated AEs (imAEs)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of laboratory abnormalities
    Time Frame:Up to 5 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Trial Keywords

    • immunotherapy
    • NKTR-214
    • nivolumab

    Last Updated

    December 20, 2019