You are here

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

Last updated on October 11, 2018

FOR MORE INFORMATION
Study Location
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urothelial Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization

- Prior immunotherapy with IL-2, IFN-?, 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.

NCT02603432
Pfizer
Recruiting
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urothelial Cancer
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
668
July 24, 2020
July 25, 2019   (Final data collection date for primary outcome measure)

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-?, 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Czech Republic
 
NCT02603432
B9991001
2015-003262-86 ( EudraCT Number )
JAVELIN BLADDER 100 ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now