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Trial record 1 of 1 for:    NCT02603432
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A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

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ClinicalTrials.gov Identifier: NCT02603432
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 9, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date June 18, 2018
Actual Study Start Date  ICMJE April 28, 2016
Estimated Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Overall Survival [ Time Frame: Up to approximately 40 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02603432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • Progression-Free Survival [ Time Frame: Up to approximately 40 months ]
    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.
  • Objective Response [ Time Frame: Up to approximately 40 months ]
    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.
  • Duration of Response [ Time Frame: Up to approximately 40 months ]
    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.
  • Disease Control [ Time Frame: Up to approximately 40 months ]
    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.
  • Cmax [ Time Frame: Up to approximately 40 months ]
    Cmax defined as the maximum plasma concentration of avelumab.
  • Ctrough [ Time Frame: Up to approximately 40 months ]
    Ctrough is defined as the trough plasma concentrate at the end of an avelumab dosing interval.
  • Incidence of Anti-Drug Antibody [ Time Frame: Up to approximately 40 months ]
    Percentage of patients receiving avelumab with positive anti-Drug Antibody (ADA) and neutralizing antibodies.
  • Tumor Tissue Biomarkers [ Time Frame: Up to approximately 40 months ]
    Analyses to evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab, including but not limited to PD-L1 expression.
  • Functional Assessment of Cancer Therapy - Bladder Cancer [ Time Frame: Up to approximately 40 months ]
    To assess disease-related symptoms.
  • EuroQoL EQ-5D [ Time Frame: Up to approximately 40 months ]
    To assess health status.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Progression-Free Survival [ Time Frame: Up to approximately 40 months ]
    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.
  • Objective Response [ Time Frame: Up to approximately 40 months ]
    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.
  • Duration of Response [ Time Frame: Up to approximately 40 months ]
    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.
  • Disease Control [ Time Frame: Up to approximately 40 months ]
    Disease control (DC) is defined as CR, PR, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause.
  • Cmax [ Time Frame: Up to approximately 40 months ]
    Cmax defined as the maximum plasma concentration of avelumab.
  • Ctrough [ Time Frame: Up to approximately 40 months ]
    Ctrough is defined as the trough plasma concentrate at the end of an avelumab dosing interval.
  • Incidence of Anti-Drug Antibody [ Time Frame: Up to approximately 40 months ]
    Percentage of patients receiving avelumab with positive anti-Drug Antibody (ADA) and neutralizing antibodies.
  • Tumor Tissue Biomarkers [ Time Frame: Up to approximately 40 months ]
    Analyses to evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab, including but not limited to PD-L1 expression.
  • Functional Assessment of Cancer Therapy - Bladder Cancer [ Time Frame: Up to approximately 40 months ]
    To assess disease-related symptoms.
  • EuroQoL EQ-5D [ Time Frame: Up to approximately 40 months ]
    To assess health status.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
Official Title  ICMJE 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
Brief Summary 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.
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 Urothelial Cancer
Intervention  ICMJE
  • Biological: Avelumab
    1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
  • Other: Best Supportive Care
    BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.
Study Arms  ICMJE
  • Experimental: Arm A
    Avelumab plus Best Supportive Care (BSC)
    Interventions:
    • Biological: Avelumab
    • Other: Best Supportive Care
  • Arm B
    Best Supportive Care (BSC) alone
    Intervention: Other: Best Supportive Care
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: November 10, 2015)
668
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 24, 2020
Estimated Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czechia,   Denmark,   France,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02603432
Other Study ID Numbers  ICMJE B9991001
2015-003262-86 ( EudraCT Number )
JAVELIN BLADDER 100 ( Other Identifier: Alias Study Number )
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 Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2018

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