A Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer
Overview
- Phase
- Phase 2
- Intervention
- Atezolizumab
- Conditions
- Urothelial Carcinoma
- Sponsor
- Arjun Balar, MD
- Enrollment
- 16
- Locations
- 8
- Primary Endpoint
- Overall Survival (OS) Rate at 1 Year
- Status
- Terminated
- Last Updated
- last year
Overview
Brief 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)
Investigators
Arjun Balar, MD
Sponsor-Investigator
Hoosier Cancer Research Network
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A - Atezolizumab + Bevacizumab
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Intervention: Atezolizumab
Arm A - Atezolizumab + Bevacizumab
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Overall Survival (OS) Rate at 1 Year
Time Frame: 1 years
Determine the percentage of overall survival at 1 years from the initiation of treatment. Overall survival is defined as the time from treatment start until death or date of last contact.
Secondary Outcomes
- Objective Response Rate (ORR)(Up to a maximum of 14 months)
- Duration of Response (DOR)(Up to a maximum of 14 months)
- Progression-Free Survival (PFS)(Time of treatment start until the criteria for disease progression or death, up to a maximum of 36 months.)
- Number of Participants With Adverse Events(Adverse events were recorded from time of registration until 30 days after discontinuation of study drug(s), up to maximum of 12 months)