Title
HCRN GU15-215 Bladder Cis Ineligible
Study Title
A Randomized Phase II Trial of Atezolizumab With or Without Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer: Hoosier Cancer Research Network GU15-215
Malignancy
Bladder, Transitional Cell, Ureter, Urethral, Renal Pelvis, Urothelial
Investigational Agent
Atezolizumab and Bevacizumab
Drug Class
PD-L1 Antibody; VEGFR Antibody
Sponsor
Hoosier Cancer Research Network
Key Eligibility Criteria Details
- ECOG PS 0-2
- Histological or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra
- Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease
- Evaluable untreated tumor tissue for biomarker analysis.
- Willing to undergo a core needle or excisional biopsy on-treatment.
- Measurable disease
- No prior chemotherapy for locally advanced or metastatic urothelial cancer
- Perioperative chemotherapy previously administered in the neoadjuvant and/or adjuvant setting is permitted
- Ineligible for cisplatin as defined by presence of one or more of the following:
- Impaired renal function [GFR ≥ 30 but ≤ 60 cc/min].
- Grade ≥ 2 Hearing Loss (hearing loss measured by audiometry of 25 dB at two contiguous frequencies)
- Grade ≥ 2 peripheral neuropathy
- ECOG Performance Status of 2
- Solitary Kidney
- No Active or untreated central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
- Evaluable or measurable disease outside the CNS
- No metastases to midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
- No history of intracranial or spinal cord hemorrhage
- No evidence of significant vasogenic edema
- No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose allowed
- No stereotactic radiation, whole-brain radiation within 4 weeks prior to Cycle 1 Day 1
- Patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy within 3 months prior to Cycle 1 Day 1 will be excluded
- No malignancies other than urothelial cancer within 5 years prior
- No history of autoimmune disease
- Known HIV, HBV, or HCV
- No inadequately controlled hypertension (defined as persistent systolic blood pressure (SBP) > 150 and/or diastolic blood pressure (DBP) > 100 mmHg)
Objective
Primary- OS: Secondary- ORR, DoR, CBR, PFS, Safety
