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.
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.
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
Scottsdale, Arizona, 85258
Tucson, Arizona, 85710
Duarte, California, 91010
Oakland, California, 94611
Stanford, California, 94305
Denver, Colorado, 80218
New Haven, Connecticut, 06520
West Hartford, Connecticut, 06119
Miami Beach, Florida, 33140
Tampa, Florida, 33612
Harvey, Illinois, 60426
Springfield, Illinois, 62794-9677
Goshen, Indiana, 46526
Indianapolis, Indiana, 46237
Sioux City, Iowa, 51101
Louisville, Kentucky, 40202
New Orleans, Louisiana, 70112
Boston, Massachusetts, 02114
Boston, Massachusetts, 02115
Boston, Massachusetts, 02215
Ann Arbor, Michigan, 48106
Detroit, Michigan, 48202
St. Cloud, Minnesota, 56303
Jackson, Mississippi, 39202
Saint Louis, Missouri, 63110
Albuquerque, New Mexico, 87131-0001
Abany, New York, 12208
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Easton, Pennsylvania, 18045
Philadelphia, Pennsylvania, 19107
Pittsburgh, Pennsylvania, 15212
Charleston, South Carolina, 29425
Houston, Texas, 77030
San Antonio, Texas, 78229
Charlottesville, Virginia, 22908
Norfolk, Virginia, 23502
Spokane, Washington, 99208
Clinical Trials
Study Director
Genentech, Inc.