BLADDER: Metastatic: 1st line: Cisplatin Ineligible: HCRN GU15-215

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

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

Site Link
Malignancy
Bladder, Transitional Cell, Ureter, Urethral, Renal Pelvis, Urothelial
Stage
Disease Setting
Metastatic Palliative
Line Of Therapy
1st Line
Investigational Agent
Atezolizumab and Bevacizumab
Drug Class
PD-L1 Antibody; VEGFR Antibody
PI
Dan Vaena, MD
Sponsor
Hoosier Cancer Research Network
Phase
Status
Key Eligibility Criteria
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

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Transitional Cell Carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X