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Brief Title: A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes
Official Title: A Phase Ib Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered Alone or in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Study ID: NCT02508870
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Stanford University, Palo Alto, California, United States
University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
University of Kansas Medical Center, Westwood, Kansas, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Nebraska Medical Center; UNMC Oncology/Hematology, Omaha, Nebraska, United States
Montefiore Einstein Cancer Center, Bronx, New York, United States
Roswell Park Cancer Institute; Grace Cancer Drug Center, Buffalo, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Medical University of South Carolina; Hollings Cancer Center, Charleston, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Virginia Health System; Hematology/Oncology Division, Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR