Clinical Trials /

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

NCT02603432

Description:

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
  • Official Title: A Phase 3, Multicenter, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (MSB0010718C) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: B9991001
  • SECONDARY ID: 2015-003262-86
  • SECONDARY ID: JAVELIN BLADDER 100
  • NCT ID: NCT02603432

Conditions

  • Urothelial Cancer

Interventions

DrugSynonymsArms
AvelumabArm A

Purpose

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalAvelumab plus Best Supportive Care (BSC)
  • Avelumab
Arm BOtherBest Supportive Care (BSC) alone

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed, unresectable locally advanced or metastatic transitional
                 cell carcinoma of the urothelium
    
              -  Stage IV disease at the start of first-line chemotherapy
    
              -  Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy
    
              -  Prior first-line chemotherapy must have consisted of at least 4 cycles and no more
                 than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin
    
              -  No evidence of progressive disease following completion of first-line chemotherapy
                 (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )
    
            Exclusion Criteria:
    
              -  Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
    
              -  Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
                 anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug
                 specifically targeting T-cell co-stimulation or immune checkpoint pathways
    
              -  Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however,
                 alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse
                 events not constituting a safety risk based on the investigator's judgement are
                 acceptable.
    
              -  Patients with known symptomatic central nervous system (CNS) metastases requiring
                 steroids
    
              -  Diagnosis of any other malignancy within 5 years prior to randomization, except for
                 adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the
                 breast or of the cervix, low grade prostate cancer on surveillance without any plans
                 for treatment intervention, or prostate cancer that has been adequately treated with
                 prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall Survival
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Patients last known to be alive will be censored at date of last contact.

    Secondary Outcome Measures

    Measure:Progression-Free Survival
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Progression-free survival (PFS) is defined as the time from randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first.
    Measure:Objective Response
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Objective response (OR) is defined as a complete response (CR) or partial response (PR) according to RECIST v1.1 recorded from date of randomization until disease progression or death due to any cause.
    Measure:Duration of Response
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Duration of response (DR) is defined, for patients with an objective response per RECIST v1.1, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
    Measure:Disease Control
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Disease control (DC) is defined as CR, PR, non-CR/non-PD, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause.
    Measure:Cmax
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Cmax defined as the maximum plasma concentration of avelumab.
    Measure:Ctrough
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Ctrough is defined as the trough plasma concentrate at the end of an avelumab dosing interval.
    Measure:Incidence of Anti-Drug Antibody
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Percentage of patients receiving avelumab with positive anti-Drug Antibody (ADA) and neutralizing antibodies.
    Measure:Tumor Tissue Biomarkers
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:Analyses to evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab, including but not limited to PD-L1 expression.
    Measure:Functional Assessment of Cancer Therapy - Bladder Cancer
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:To assess disease-related symptoms.
    Measure:EuroQoL EQ-5D
    Time Frame:Up to approximately 40 months
    Safety Issue:
    Description:To assess health status.

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Pfizer

    Trial Keywords

    • Bladder cancer
    • Urologic neoplasms
    • urothelial carcinoma
    • PD-L1
    • programmed cell death protein
    • maintenance treatment

    Last Updated