A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as First-Line Treatment for Metastatic Bladder Cancer (NCT03093922)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (50 items).
Location: University of Chicago โ Chicago, Illinois
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck 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).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior chemotherapy or immunotherapy for metastatic urothelial cancer. Prior neoadjuvant or adjuvant chemotherapy with first progression \> 12 months is allowed. Prior intravesical treatments such as BCG are allowed, however no BCG is allowed within 4 weeks prior to initiation of study treatment.
- Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
- Hormone-replacement therapy or oral contraceptives
- Herbal therapy \> 1 week prior to Cycle 1, Day 1. Herbal therapy intended as anticancer therapy must also be discontinued at least 1 week prior to Cycle 1, Day 1.
- Palliative radiotherapy for bone metastases \> 2 weeks prior to Cycle 1, Day 1
- Bisphosphonate therapy for symptomatic hypercalcemia ยฐUse of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed.
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
- Patients with a history of or active bone marrow disorders expected to interfere with study therapy (e.g. acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma)
- Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
- Evaluable or measurable disease outside the CNS
- No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (9 Sites)
- University of Chicago โ Chicago, Illinois
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) โ Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) โ Middletown, New Jersey
- Memorial Sloan Kettering Bergen โ Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities) โ Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) โ Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) โ New York, New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) โ Uniondale, New York
- Ohio State University โ Columbus, Ohio
๐ฐ 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 ยง 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.