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About
In this trial the investigators aim to evaluate safety and efficacy of combination Ivosidenib (AG-120) and nivolumab in the context of adult patients with Isocitrate dehydrogenase-1 (IDH1) mutated acute myeloid leukemias (AML) or Myelodysplastic syndromes (MDS).
Full description
Primary objectives:
Exploratory objectives:
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Inclusion criteria
Exclusion criteria
Prior exposure to IDH targeted agents
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Acute Promyelocytic leukemias
Active Central Nervous System (CNS) disease
Participants who have received a live/ attenuated vaccine within 30 days of first treatment. Any live vaccine (ex: varicella, zoster, yellow fever, rotavirus, oral polio and measles mumps, rubella (MMR) are strictly prohibited during and for a 100 days post last treatment.
Autoimmune disease: Patients with active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Medical history of Progressive multifocal leukoencephalopathy
Patients who are unable to take PO regularly, with active gastroparesis, short gut syndrome or other malabsorption syndrome.
Any significant medical/social condition that could limit the understanding of the study or the compliance to the protocol including but not limited to uncontrolled infection, severe or uncontrolled psychiatric illness, platelet refractoriness
Use of strong cytochrome P-450 3A4 (CYP3A) inducers or inhibitors that cannot be safely replaced by other medications. This includes: alfentanil, aprepitant, budesonide, buspirone, conivaptan, darifenacin, darunavir, dronedarone, eletriptan, eplerenone, felodipine, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, quetiapine, saquinavir, sildenafil, simvastatin, tolvaptan, tipranavir, triazolam, ticagrelor, vardenafil and/or the CYP2B6 substrates: bupropion, efavirenz. Posaconazole and voriconazole are not strictly prohibited, but all alternatives much be explored and use of these agents must be discussed with the Sponsor PI.
Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of nivolumab. Corticosteroids with minimal systemic absorption (for example, topical or inhalational and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease). Use of steroids to treat toxicities acceptable is acceptable based on the local investigators standard of care).
Prior malignancies: Any malignancy less than 1 year after end of treatment. Any malignancy presenting signs of active disease. Basal cell carcinoma and superficial cervix cancer can be included.
History of any of the following cardiovascular conditions within 12 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association. Patients with heart-rate corrected QT interval using Fridericia's method (QTcF) >=450 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome). Subjects with prolonged QTcF interval in the setting of bundle branch block or pacemaker should be considered with documented consultation of a cardiologist.
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Any known history of a positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
Supplemental oxygen dependency or clinically significant interstitial lung disease.
Pregnant or nursing women
Active alcohol or drug abuse
Patient suitable for allogeneic transplantation and with an identified allogeneic donor at the time of screening.
Patients post allogeneic transplantation may be included on the trial if they are:
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Data sourced from clinicaltrials.gov
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