A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as … (NCT03093922) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as First-Line Treatment for Metastatic Bladder Cancer
United States32 participantsStarted 2017-03-22
Plain-language summary
The purpose of this study is to compare any good and bad effects the study drug atezolizumab has on the cancer when combined with the standard chemotherapy drugs gemcitabine and cisplatin (or GC) in two different dosing schedules: chemotherapy (GC) before atezolizumab vs. GC after atezolizumab.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed urothelial carcinoma of the bladder, ureter, urethra, or renal pelvis by the enrolling institution. Patients with mixed histologies are required to have a predominant urothelial component as reviewed by the pathologist at the enrolling institution.
* Locally advanced (T4b, any N: any T, N2-3) or metastatic (M1) disease as determined by the treating investigator.
* Age ≥18 years
* Life expectancy ≥ 12 weeks
* The patient must have measurable disease according to RECIST v1.1 and must have one site amenable to biopsy that, in the opinion of the investigator and/or interventional radiologist, is likely to yield acceptable tumor sample for a core biopsy per the below pathology criteria.
* Subject must agree to undergo two research-directed biopsies during treatment.
* Patients must have adequate tumor tissue available for PD-L1 testing. Adequate tumor tissue is defined as:
* For core-needle biopsy specimens, at least three cores should be submitted for evaluation if feasible. Acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Samples collected from fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases without a soft tissue component, and lavage are not acceptable.
* For pre-treatment archival tissue, representative urothelial carcinoma FFPE tumor specime…