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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

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

New York, New York, 10016

Rochester, New York, 14642

Columbus, Ohio, 43210

Eugene, Oregon, 97401-8122

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.

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