Bladder Cancer MSK 16-1428

A Pilot Safety Study and Single Arm Phase II Study of Gemcitabine and Cisplatin With Atezolizumab (MPDL3280A) in Patients With Metastatic and Muscle Invasive Bladder Cancer, Respectively

The purpose of this study is to test the safety of the study drug, atezolizumab, when combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study will help researchers begin to understand whether combining GC with atezolizumab is better, the same, or worse than the usual approach of using GC alone.

Eligibility Criteria:

1. Patient must be at least 18 years of age.
2. ECOG Performance Status of 0 or 1.
3. Required Initial Laboratory Values within 14 days of enrollment:
   • Absolute Neutrophil Count ≥ 1500 cells/mm^3
   • Lymphocyte count ≥ 300/mm^3
   • Platelets ≥ 100,000 cells/mm^3
   • Hemoglobin ≥ 9.0 g/Dl
   • Bilirubin ≤ 1.5 the upper limit of normal (ULN) for the institution For patients with known Gilbert's disease: bilirubin ≤ 3 x ULN
   • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN for the institution.
     • For patients in the metastatic cohort with documented liver or bone metastases: AST and/or ALT ≤ 5.0 x ULN.
   • Alkaline phosphatase ≤ 2.5 x ULN for the institution:
     • For patients in the metastatic cohort with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN.
   • If female of childbearing potential, urine pregnancy test is negative.
   • INR and aPTT ≤ 1.5 x ULN if not on therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut, Midstate Medical Center, Backus Hospital