At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
pembrolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Study of Azacitidine in Combination With Pembrolizumab in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients and in Newly Diagnosed Older (≥65 Years) AML Patients
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jul 27, 2016·Updated Mar 9, 2023
In Brief
A Phase 2 clinical trial evaluating pembrolizumab and Azacitadine for Acute Myeloid Leukemia. Completed, enrolled 67 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJul 2016
First PostedJul 2016
Primary CompletionApr 2022
Study CompletionDec 2022
TodayJul 2026
First PostedJul 27, 2016
Enrollment StartJul 1, 2016
Primary CompletionApr 1, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 9.9 years ago
Interventions
pembrolizumabdrug
Intravenous pembrolizumab
Azacitadinedrug
Intravenous or subcutaneous