Clinical Trial TitleA Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Patients with Advanced/Unresectable Urothelial Cancer
National Clinical Trial Number:NCT03272217
Clinical Trial Protocol Description:
The single-arm phase II study, known as HCRN GU15-215, involves the anti-PD-L1 antibody atezolizumab with bevacizumab, a VEGF-targeting antibody that may help to prevent the growth of new blood vessels that feed tumors. Bevacizumab may act in combination with atezolizumab to enhance the anti-tumor immune response. This combination has not been approved by the U.S. Food and Drug Administration to treat advanced/unresectable bladder cancer and should be considered
investigational. About 70 subjects will participate in the study.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at the time of consent.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 within 28 days prior to registration.
- Have histological or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra.
- Have locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease.
You will be excluded from the study if any of the following criteria apply to you:
- Have had any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed:
- Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging
- Hormone-replacement therapy or oral contraceptives
- Have had treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment.
- Have active or untreated central nervous system (CNS) metastases or leptomeningeal disease as determined by computed tomography (CT) scan.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.