Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients

Phase 2 Completed 67 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Merck Sharp & Dohme LLC · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, nonrandomized, open-label phase 2 study (with a safety run-in phase) of azacitidine (AZA) 75 mg/m2 given IV or SQ on days 1-7 every 28 days in combination with pembrolizumab 200 mg given IV every 3 weeks (starting on day 8 of cycle 1). The dose/schedule of AZA selected for this study is FDA approved for patients with MDS/AML.

Timeline

Start: 2016-07
Primary completion: 2022-04
Completion: 2022-12

Publications

Rutella S, Vadakekolathu J, Mazziotta F, Reeder S, Yau TO, Mukhopadhyay R, Dickins B, Altmann H, Kramer M, Knaus HA, Blazar BR, Radojcic V, Zeidner JF, Arruda A, Wang B, Abbas HA, Minden MD, Tasian SK, Bornhauser M, Gojo I, Luznik L. Immune dysfunction signatures predict outcomes and define checkpoint blockade-unresponsive microenvironments in acute myeloid leukemia. J Clin Invest. 2022 Nov 1;132(21):e159579. doi: 10.1172/JCI159579.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	75 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients

Summary

Timeline

Publications

Drugs

Indications