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

Trial ID or NCT#

NCT02508870

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Diagnosis of MDS (participants with therapy-related MDS are eligible) - Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (
Exclusion Criteria:
  1. - 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)
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Investigator(s)

Peter Greenberg
Peter Greenberg
Hematologist-Oncologist
Professor of Medicine (Hematology), Emeritus

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov