A Safety and Pharmacology Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) Administered Alone or in Combination With Azacitidine in Patients With Myelodysplastic Syndromes | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02508870

A Safety and Pharmacology Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) Administered Alone or in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This is a non-randomized, open-label, Phase 1 study of Atezolizumab (MPDL3280A, Anti-PD-L1 antibody) monoclonal antibody [mAb] in intermediate/high/very high-risk myelodysplastic syndromes (MDS) patients, as evaluated by the International Prognostic Scoring System-Revised (IPSS-R). Eligible participants will either have never received treatment with hypomethylating agents(s) (HMAs) or have relapsed or are refractory to prior HMA therapy. The primary objectives of this study are to determine the safety and feasibility of Atezolizumab therapy in these patient populations, including treatment in combination with azacitidine.

Status: 
Recruiting
Study Date: 
Tue, 09/01/2015 to Fri, 03/01/2019
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Atezolizumab 1200 mg Atezolizumab intravenously (IV) every 3 weeks on Day 1 of each 21-day cycle Drug: Atezolizumab 840 mg Atezolizumab IV every 2 weeks on Days 8 and 22 of each 28-day cycle Drug: Azacitidine 75 mg/m2 azacitidine subcutaneously (SC) or IV daily on Days 1-7 (or on Days 1-5 and Days 8-9, depending on site preference) of each 28-day cycle Other Name: Vidaza