UM1 10009 Pembro + Entinostat in Myelodysplastic Syndromes - Clinical Trial
What is the Purpose of this Study?
We are doing this study to test whether giving entinostat by mouth along with the other drug pembrolizumab by vein is a safe combination and whether it could help your MDS or AML.
Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that arose from prior MDS
Who Can Participate in the Study?
Adults who have:
- Confirmed MDS diagnosis
- Acute myeloid leukemia (AML) that arose from prior MDS
What is Involved?
If you agree to be in the study you will:
- Be assigned to one of 2 groups (you will be told which group you are assigned)
Group 1 (Dose escalation)
- Get the study drug entinostat with a fixed dose of pembrolizumab
-- The first 3 to 6 study patients will get entinostat on day 1 and day 8 of each cycle.
-- The next 3 to 6 study patients will get entinostat only on day 1 of each cycle.
-- If this dose does not cause serious side effects, this dose will be used in the next part of the study (Dose expansion group-see below)
Group 2 (Dose Expansion)
- Will get entinostat given with pembrolizumab
The study drugs are given as follows:
- Entinostat by mouth either on day 1 alone, on day 1 and 8, or on days 1, 8, and 15 at the study center (depending at what point you join in the study) on a 21 day cycle
- Pembrolizumab once every 21 days by vein at the study center