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

This study is currently recruiting participants.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02603432
First Posted: November 11, 2015
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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.

Condition Intervention Phase
Urothelial Cancer Biological: Avelumab Other: Best Supportive Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 668
Actual Study Start Date: April 28, 2016
Estimated Study Completion Date: July 24, 2020
Estimated Primary Completion Date: July 25, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Avelumab plus Best Supportive Care (BSC)
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.
Arm B
Best Supportive Care (BSC) alone
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603432


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 334 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02603432     History of Changes
Other Study ID Numbers: B9991001
2015-003262-86 ( EudraCT Number )
JAVELIN BLADDER 100 ( Other Identifier: Alias Study Number )
First Submitted: November 9, 2015
First Posted: November 11, 2015
Last Update Posted: November 10, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Bladder cancer
Urologic neoplasms
urothelial carcinoma
PD-L1
programmed cell death protein
maintenance treatment

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs