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

Completed · Phase 3

Conditions studied: Urothelial Cancer

In brief

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.

Key facts

Study ID

NCT02603432

Run by

Pfizer

People needed

700

Starts

2016-04-25

Expected to finish

2023-03-28

Last updated by the study team

2024-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 )

You may not qualify if…

• 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.

Where it is running

• University of Colorado Cancer Center — Aurora, Colorado, United States
• University of Colorado Denver, CTO (CTRC) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Cleveland Clinic Taussing Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Taussing Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Cleveland Clinic Taussing Cancer Center — Cleveland, Ohio, United States
• Inova Schar Cancer Institute Infusion Pharmacy — Fairfax, Virginia, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Centro de Investigacion Pergamino S.A. — Pergamino, Buenos Aires, Argentina
• Fundación CENIT para la Investigación en Neurociencias — CABA, Argentina
• GP Diagnostico SRL — La Rioja, Argentina
• Hospital Regional Dr. Enrique Vera Barros — La Rioja, Argentina
• Instituto del Diagnostico — La Rioja, Argentina
• Centro Oncologico Riojano Integral (Cori) — La Rioja, Argentina
• Anschutz Cancer Center Pavilion Pharmacy — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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