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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.

NCT04209114

Description:

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.

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