OncoMatch/Clinical Trials/NCT03969446
Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory
Is NCT03969446 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Pembrolizumab and Decitabine for acute myeloid leukemia.
Treatment: Decitabine · Pembrolizumab · Venetoclax — This phase Ib trial studies the side effects and best dose of pembrolizumab and how well it works in combination with decitabine with or without venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly-diagnosed, has come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. This trial may help doctors find the best dose of pembrolizumab that can be safely given in combination with decitabine with or without venetoclax, and to determine what side effects are seen with this treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: allogeneic cell transplantation
Previous allogeneic cell transplantation
Cannot have received: pembrolizumab (pembrolizumab)
Previous treatment with pembrolizumab
Cannot have received: decitabine + venetoclax (decitabine, venetoclax)
Previously refractory to treatment with decitabine + venetoclax (i.e. progressed through therapy without first attaining at least a partial response)
Cannot have received: anti-PD-1/PD-L1/PD-L2 agent
Prior therapy with any other anti-programmed cell death protein-1 (anti-PD-1), or PD ligand-1 (PD-L1) or PD ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
Cannot have received: anti-CD137, anti-CTLA-4 antibody, denosumab, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (anti-CD137, anti-CTLA-4, denosumab)
Prior therapy with an anti-CD137, anti-CTLA-4 antibody (including ipilimumab), denosumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: radiotherapy
Exception: A 1-week washout is permitted for palliative radiation (<=2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received prior radiotherapy within 2 weeks of start of study intervention
Lab requirements
Blood counts
White blood cells (WBC) <= 25 x 10^9/L prior to initiation of venetoclax; INR or PT <= 1.5 x ULN; aPTT <= 1.5 x ULN
Kidney function
Creatinine clearance of > 30 mL/min per 24-hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin <= 2 x upper limit of normal (ULN) (unless has Gilbert's disease); AST and ALT <= 2.5 x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) >= 50%; Corrected QT (QTc) <= 480 ms
WBC <= 25 x 10^9/L prior to initiation of venetoclax. Total bilirubin <= 2 x ULN (unless has Gilbert's disease). AST and ALT <= 2.5 x ULN. Creatinine clearance of > 30 mL/min per 24-hour urine test or the Cockcroft-Gault formula. INR or PT <= 1.5 x ULN. aPTT <= 1.5 x ULN. LVEF >= 50%. QTc <= 480 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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