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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.

What is the Condition Being Studied?

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
or
- Acute myeloid leukemia (AML) that arose from prior MDS

Age Group
Adults

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

Study Details

Full Title
A Phase 1b study of the anti-PD1 antibody Pembrolizumab in combination with the histone deacetylase inhibitor, Entinostat for treatment of patients with Myelodysplastic Syndromes after DNA methyltransferase inhibitor therapy failure (10009)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00100355
NCT:NCT02936752
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698