Official Title
An Open-Label, Multicenter, Expanded Access Program for Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy.
Brief Summary

This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to provide atezolizumab access to participants with locally advanced or metastatic urothelial carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy regimen.

Approved for marketing
Urothelial Carcinoma

Drug: 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

Inclusion Criteria:

- Able to comply with the study protocol, in the investigator's judgment

- 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 any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to enrollment

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

St. Cloud, Minnesota, United States

Jackson, Mississippi, United States

Saint 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

Clinical Trials, Study Director
Genentech, Inc.

Genentech, Inc.
NCT Number
MeSH Terms
Carcinoma
Carcinoma, Transitional Cell
Atezolizumab