An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy
NCT ID: NCT02589717
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
2015-11-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Atezolizumab [TECENTRIQ]
Atezolizumab 1200 mg will be administered by IV infusion q3w. Initial IV infusion will be given over 60 minutes and subsequent infusions will be given over 30 minutes.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra)
* Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin \[GC\], methotrexate, vinblastine, doxorubicin, and cisplatin \[MVAC\], carboplatin and gemcitabine \[CarboGem\], etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life expectancy \>/= 12 weeks
* Adequate hematologic and end-organ function, defined by laboratory results obtained within 14 days prior to the first study treatment
* For women who are not postmenopausal (\>/= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 90 days after the last dose of study drug
Exclusion Criteria
* Treatment with chemotherapy 14 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
* Treatment with radiotherapy 7 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
* Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
* Pregnant or lactating, or intending to become pregnant during the study
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
* Severe infections within 4 weeks prior to enrollment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
* Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
* Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of disease or a condition that contraindicates the use of the investigational drug or renders the participant at high risk for treatment complications
* Participants with active hepatitis B
* Active tuberculosis
* Administration of a live, attenuated vaccine within 4 weeks prior to enrollment or anticipation that such a live, attenuated vaccine will be required during the study
* Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or IL-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
* Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to enrollment or anticipated requirement for systemic immunosuppressive medications during the trial
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Scottsdale, Arizona, United States
Tucson, Arizona, United States
Duarte, California, United States
Oakland, California, United States
Stanford, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
West Hartford, Connecticut, United States
Miami Beach, Florida, United States
Tampa, Florida, United States
Harvey, Illinois, United States
Springfield, Illinois, United States
Goshen, Indiana, United States
Indianapolis, Indiana, United States
Sioux City, Iowa, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Saint Cloud, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Abany, New York, United States
New York, New York, United States
Rochester, New York, United States
Columbus, Ohio, United States
Eugene, Oregon, United States
Easton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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ML29725
Identifier Type: -
Identifier Source: org_study_id