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

Completed · Phase 1

Conditions studied: Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT02508870

Run by

Hoffmann-La Roche

People needed

46

Starts

2015-09-30

Expected to finish

2019-06-10

Last updated by the study team

2019-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of MDS (participants with therapy-related MDS are eligible)
• Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (</=) 2
• Adequate end-organ function, as determined by laboratory tests obtained within 28 days prior to the first dose of study drug
• Willing and able to undergo a pre-treatment bone marrow biopsy and subsequent on-treatment bone marrow biopsies
• Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 28 days prior to initiation of study drug
• For women of childbearing potential and men: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive measures
• For participants in Cohorts A, A2, B, and B2:
• Progression at any time after initiation of azacitidine or decitabine treatment OR
• Failure to achieve complete or partial response or hematological improvement after at least six 4-week cycles of azacitidine or either four 4-week or four 6-week cycles of decitabine OR
• Relapse after initial complete or partial response or hematological improvement after six 4-week cycles of azacitidine or either four 4-week or four 6-week cycles of decitabine administered within the past 2 years
• For participants in Cohorts C1 and C2:
• Must not have received prior treatment for MDS with any hypomethylating agent
• IPSS-R risk category of Intermediate, High, or Very High assessed at screening

You may not qualify if…

• Participants with a diagnosis of MDS secondary to paroxysmal nocturnal hemoglobinuria (PNH), aplastic anemia, or another inherited bone marrow failure disorder
• Prior allogeneic stem cell transplant or solid organ transplant
• Pregnant or lactating, or intending to become pregnant during the study
• Investigational therapy within 28 days prior to initiation of study treatment
• Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
• Prior treatment with immune checkpoint blockade therapies (anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-programmed death-1 [PD-1] or anti-PD-L1) or immune agonists (anti-cluster of differentiation [CD] 137, anti-CD40, anti-OX40)
• Any other therapy or serious medical condition, as specified in the protocol, or abnormality in clinical laboratory tests that, in the investigator's judgement, precludes the participant's safe participation in and completion of the study
• Left ventricular ejection fraction (LVEF) </= 40 percent (%) at screening
• Planned major surgery during the study or within 4 weeks of Cycle 1, Day 1
• History of idiopathic pulmonary fibrosis, organizing pneumonitis, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

Where it is running

• 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
• Roswell Park Cancer Institute; Grace Cancer Drug Center — Buffalo, New York, United States
• Montefiore Einstein Cancer Center — The Bronx, 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

Full record on ClinicalTrials.gov

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