drugset / Trial / NCT02508870

A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes

NCT02508870 ↗

Phase 1 Completed 46 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, Phase 1b study of atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] monoclonal antibody) in participants who have hypomethylating agent (HMA)-naïve myelodysplastic syndromes (MDS) and are International Prognostic Scoring System-Revised (IPSS-R) intermediate/high/very high-risk, or have MDS relapsed or are refractory (R/R) to prior HMA therapy. The primary objectives of this study are to determine the safety and tolerability of atezolizumab therapy in these participant populations, including treatment in combination with azacitidine.

Timeline

Start
2015-09-30
Primary completion
2019-06-10
Completion
2019-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous