Myelodysplastic Syndrome Clinical Trial
Official title:
A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients With MDS
This phase II trial studies the side effects of azacitidine and pembrolizumab and to see how well they work in treating patients with myelodysplastic syndrome. Azacitidine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving azacitidine and pembrolizumab may work better at treating myelodysplastic syndrome.
PRIMARY OBJECTIVES: I. To assess the safety of the combination of azacitidine and MK3475 (pembrolizumab) in patients with higher risk myelodysplastic syndrome (MDS). II. To explore the clinical activity (response, survival effect) of the combination of azacitidine with MK-3475 in patients with higher risk MDS. EXPLORATORY OBJECTIVES: I. To study the biological effects of the combination of azacitidine and pembrolizumab in patients with MDS treated on this study. OUTLINE: Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 30 days, every 12 weeks for 1 year, then annually thereafter. ;
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