an expanded access study of atezolizumab in participants with locally advanced or metastatic urothelial carcinoma after failure with platinum-containing chemotherapy

Conditions: Urothelial Carcinoma

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.


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