Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer (NCT03237780)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Males or females age \> or = 18 years at the time of informed consent. Because no dosing or adverse event data are currently available on the use of atezolizumab in combination with eribulin in patients \< 18 years of age, children are excluded from this study
2. Histologically- or cytologically-confirmed diagnosis of locally advanced/unresectable (inoperable or not amenable to surgical treatment) and/or metastatic transitional cell urothelial cancer of the renal pelvis, ureter, urinary bladder, or urethra
3. Presence of measurable disease meeting the following criteria:
4. At least one lesion of \>= 1.0 cm in long axis diameter for non-lymph nodes or \>= 1.5 cm in short axis diameter for lymph nodes that is serially measurable according to RECIST 1.1 using either computerized tomography or magnetic resonance imaging or panoramic and close-up color photography with caliper measurement; if there is only one target lesion and it is a not a lymph node, it should have a long-axis diameter of at least 1.5 cm
5. Lesions that have had radiotherapy must show radiographic evidence of disease progression based on RECIST 1.1 may be deemed a target lesion
6. Archival paraffin-embedded invasive tumor tissue or newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis; patients must be offered sequential biopsies at baseline and 6 weeks unless in the opinion of the trial principal investigator (PI) this would be hazardous; recent data suggest discordance between primary tumor and tumor from recurrence or metastasis with high percentages of PD-L1 SP142 positive immune cells after recurrence
7. PD-L1 status determined centrally by HistogeneX, which is funded by the study, must be available before randomization of the patient to allow for stratification; COMMERCIAL ASSESSMENT OF PD-L1 STATUS OBTAINED LOCALLY AT THE SITE WILL NOT SATISFY ELIGIBILITY CRITERIA
8. New, progressive or recurrent disease occurring
9. During or within 12 months of treatment with a platinum containing regimen (cisplatin or carboplatin or novel platinum) in either in the metastatic or perioperative setting
10. In first-line patients defined as cisplatin-ineligible based on renal impairment (creatinine clearance calculated by Cockcroft-Gault method \< 60 ml/min), at least grade 2 hearing loss and/or Eastern Cooperative Oncology Group (ECOG) status of 2; these patients will be chemotherapy naive or have received platinum based therapy in the adjuvant or neoadjuvant setting more than 12 months prior to study entry
11. May have received up to two prior lines of chemotherapy for advanced disease
12. Adequate recovery from any adverse events resulting from prior anti-neoplastic treatment including chemotherapy, biological therapy, targeted small molecule therapy, radiation therapy, and surgery as determined by the investigator (and in consultation with the study PI); in most instances, adequate recovery is resolution to =\< grade 1 except for alopecia of any grade, grade 2 neuropathy and/ or any grade hearing loss

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (21 Sites)

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Keck Medicine of USC Buena Park — Buena Park, California
• City of Hope Comprehensive Cancer Center — Duarte, California
• City of Hope at Irvine Lennar — Irvine, California
• Keck Medicine of USC Koreatown — Los Angeles, California
• Los Angeles General Medical Center — Los Angeles, California
• USC / Norris Comprehensive Cancer Center — Los Angeles, California
• USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
• Keck Medical Center of USC Pasadena — Pasadena, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• City of Hope Upland — Upland, California
• University of Kansas Clinical Research Center — Fairway, Kansas
• University of Kansas Cancer Center — Kansas City, Kansas
• University of Kansas Cancer Center-Overland Park — Overland Park, Kansas
• University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
• University of Kansas Cancer Center - North — Kansas City, Missouri
• University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri
• University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City, Missouri
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.