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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is a non-randomized, open-label, Phase 1 study of atezolizumab (anti programmed death-ligand 1 [anti-PD-L1] monoclonal antibody) in intermediate/high/very high-risk myelodysplastic syndromes (MDS) participants, as evaluated by the International Prognostic Scoring System-Revised (IPSS-R). Eligible participants will either have never received treatment with hypomethylating agent(s) (HMAs) or have relapsed or are refractory (R/R) to prior HMA therapy. The primary objectives of this study are to determine the safety and feasibility 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 (MPDL3280A, Anti-PD-L1 Antibody) Administered Alone or in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes Azacitidine Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of MDS (participants with therapy-related MDS are eligible)
  • Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (

  • 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 participant in Cohorts A and B:

  • Progression at any time after initiation of azacitidine or decitabine treatment
  • 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
  • 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

You CAN'T join if...

  • Participants with a diagnosis of hypoplastic MDS or 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)

Locations

  • Stanford University accepting new patients
    Palo Alto, California, 94304, United States
  • City of Hope accepting new patients
    Duarte, California, 91010, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02508870
Phase
Phase 1
Study Type
Interventional
Last Updated
July 1, 2017
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