A Study Evaluating the Safety and Pharmacology of Atezolizumab Administered in Combination With Immunomodulatory Agents in Participants With Acute Myeloid Leukemia (AML)
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Life expectancy of at least 12 weeks
Diagnosis of AML per World Health Organization criteria
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
Specifically, for participants in Cohorts A1 and A2: Age greater than or equal to (\>=) 18 years, disease progression or failure to achieve complete or partial response after intensive cytotoxic therapy, participants cannot have received more than two prior intensive regimens (e.g., induction + consolidation and one salvage therapy + consolidation)
Specifically, for participants in Cohorts A3 and A4: Treatment naïve participants unfit for induction chemotherapy for AML as defined by the following: Age \>= 70 or age 65 to 69 years with at least one of the following: ECOG performance status of 2, Intermediate I/II or adverse risk cytogenetic and molecular alterations per ELN 2010 guidelines or secondary AML, or other comorbidity judged incompatible with intensive chemotherapy
Adequate end-organ function
Willing and able to undergo a pre-treatment bone marrow aspirate and biopsy and subsequent bone marrow aspirates and biopsies during treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 30 days after the last dose of guadecitabine or 5 months after the last dose of atezolizumab, whichever is longer
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
You may not be if
In Cohorts A3 and A4 only, participants with AML eligible for standard intensive induction therapy with an anthracycline and cytarabine
Prior allogeneic stem cell transplant or solid organ transplant
Active central nervous system involvement by leukemia
Pregnant or lactating, or intending to become pregnant during the study
History of idiopathic pulmonary fibrosis, organizing pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis, or autoimmune disease
Treatment with investigational therapy within 14 days prior to initiation of study drug
Any approved AML-related therapy within 14 days prior to enrollment
Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
Daily requirement for corticosteroids (\> 10 mg prednisone daily or equivalent) (except for inhalation corticosteroids) within 2 weeks prior to Cycle 1, Day 1
Prior treatment with immune checkpoint blockade therapies (anti-cytotoxic T-lymphocyte-associated protein 4 \[anti-CTLA-4\], anti-programmed death-1 \[anti-PD-1\] or anti-PD-L1) or immune agonists (anti-cluster of differentiation \[CD\]137, anti-CD40, anti-OX40)
Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to Cycle 1, Day 1
Treatment with denosumab (or other receptor activator of nuclear factor kappa-B ligand \[RANKL\] inhibitor) 4 weeks before the first dose and for 10 weeks after the last dose of atezolizumab
Administration of a live, attenuated vaccine within 4 weeks of Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
Planned major surgery during the study
Positive for hepatitis C virus (HCV) antibody at screening
Active hepatitis B virus (HBV) infection
Positive for human immunodeficiency virus (HIV)
Illicit drug or alcohol abuse within 12 months prior to screening
Poor peripheral venous access
Active infection
Serious infection requiring hospitalization or intravenous (IV) antibiotics within 14 days prior to enrollment
Any serious medical condition or abnormality in clinical laboratory tests
History or presence of an abnormal electrocardiogram (ECG)
History of other malignancy within 2 years prior to screening
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab or guadecitabine formulations
History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Clareo Health | A Study Evaluating the Safety and Pharmacology of Atezolizumab Administered in Combination With Immunomodulatory Agents in Participants With Acute Myeloid Leukemia (AML)
