Spots Global Cancer Trial Database for Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents
Official 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
Study ID: NCT02936752
Conditions
Study Description
Brief Summary: This phase Ib trial studies the side effects and best dose of entinostat when given together with pembrolizumab in treating patients with myelodysplastic syndrome after deoxyribonucleic acid (DNA) methyltransferase inhibitor (DNMTi) therapy failure. Entinostat may stop the growth of cancer 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 entinostat together with pembrolizumab may work better in treating patients with myelodysplastic syndrome after DNMTi therapy failure.
Detailed Description: PRIMARY OBJECTIVE: I. To assess safety, tolerability, and identify the maximum tolerated dose (MTD) of entinostat given in combination with MK-3475 (pembrolizumab). SECONDARY OBJECTIVE: I. To obtain a preliminary estimate of efficacy of entinostat in combination with MK-3475 (pembrolizumab). EXPLORATORY OBJECTIVE: I. To assess the dynamic quantitative change in measurable immunological biomarkers (proportions of myeloid-derived suppressor cells \[MDSCs\], and programmed death protein-1 \[PD-1\] expression in bone marrow) with the combined epigenetic-immunotherapy and correlation with any observed clinical responses. OUTLINE: This is a dose-escalation study of entinostat. Patients receive lower dose entinostat orally (PO) on days 1 and 8 or higher dose entinostat PO on days 1, 8, and 15, and pembrolizumab intravenously (IV) over 30 minutes on day 1 of cycle 2 and cycles thereafter. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve an objective response or maintain a stable disease (SD) status after the first 4 cycles may continue to receive entinostat and pembrolizumab for up to 1 year. After completion of study treatment, patients are followed up monthly for 6 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Nebraska Medicine-Village Pointe, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Amer M Zeidan
Affiliation: Yale University Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
