NCT03272217

Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer

A Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Arjun Balar, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study assessing the activity of bevacizumab combined with atezolizumab in metastatic urothelial carcinoma patients who are ineligible for cisplatin-based therapy.

Detailed description

This is a multi-center trial. INVESTIGATIONAL TREATMENT: Eligible patients will be receive atezolizumab 1200 mg IV flat dose plus bevacizumab 15 mg/kg IV every 21 days 21 days equals 1 cycle of therapy and patients will be eligible to continue treatment until progressive disease by RECIST v1.1 or unacceptable toxicity for up to 24 months. To demonstrate adequate organ function, all screening labs must be obtained within 14 days prior to Cycle 1 Day 1 (C1D1) of treatment: Hematological: * Absolute Neutrophil Count (ANC): ≥ 1,000 K/mm\^3 * Hemoglobin (Hgb): ≥ 9.0 g/dL * Absolute Lymphocyte Count: ≥ 500/uL * Platelet Count: ≥ 100,000/uL Renal: * Calculated Creatinine Clearance: serum creatinine \< 2.5 or ≥ 25 cc/min using a direct method or the Cockcroft-Gault formula * Urinary Protein Excretion: \< 1.0 g/24 hours (as estimated by urine protein-creatinine ratio) Hepatic: * Bilirubin: ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's Disease who have serum bilirubin ≤ 3.0 x ULN may be enrolled) * Aspartate aminotransferase (AST): ≤ 2.5 × ULN (5.0 x ULN if liver involvement) * Alanine aminotransferase (ALT): ≤ 2.5 × ULN (5.0 x ULN if liver involvement) * Serum Albumin: ≥ 2.5 g/dL Coagulation: * International Normalized Ratio (INR) or Prothrombin Time (PT); Activated Partial Thromboplastin Time (aPTT): ≤ 1.5 × ULN (NOTE: This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose)

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab 1200 mg (flat dose) IV every 21 days
DRUG	Bevacizumab	Bevacizumab 15 mg/kg IV every 21 days

Timeline

• Start date: 2017-09-13
• Primary completion: 2021-05-27
• Completion: 2022-03-17
• First posted: 2017-09-05
• Last updated: 2025-01-07
• Results posted: 2025-01-07

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study