Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

Summary

The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab), alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied. This is an investigational study. Lirilumab is not FDA approved or commercially available. It is currently being used for research purposes. Nivolumab is FDA approved and commercially available for the treatment of melanoma and non small cell lung cancer (NSCLC). Azacitidine is FDA approved and commercially available for the treatment of MDS. The study doctor can explain how the study drugs are designed to work. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Timeline

Start

2016-03-21

Primary completion

2019-01-30

Completion

2019-01-30

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies.”

Publications

• Yalniz FF, Daver N, Rezvani K, Kornblau S, Ohanian M, Borthakur G, DiNardo CD, Konopleva M, Burger J, Gasior Y, Pierce S, Kantarjian H, Garcia-Manero G. A Pilot Trial of Lirilumab With or Without Azacitidine for Patients With Myelodysplastic Syndrome. Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):658-663.e2. doi: 10.1016/j.clml.2018.06.011. Epub 2018 Jun 15.

Drugs

Indications