NCT02845297 is a Phase 2 clinical trial of pembrolizumab in Acute Myeloid Leukemia, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Who is sponsoring NCT02845297?

NCT02845297 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What drugs are being tested in NCT02845297?

Interventions in NCT02845297: pembrolizumab, Azacitadine.

What condition does NCT02845297 study?

NCT02845297 studies Acute Myeloid Leukemia.

Is NCT02845297 still recruiting?

NCT02845297 is currently completed. Last updated 7 March 2023.

Are results published for NCT02845297?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-07 · How we verify

NCT02845297

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 7 March 2023

What this trial tests

Phase 2 trial testing pembrolizumab in Acute Myeloid Leukemia in 67 participants. Completed in 1 December 2022.

Timeline

1 July 2016

Primary endpoint
1 April 2022

1 December 2022

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	1 July 2016
Primary completion	1 April 2022
Estimated completion	1 December 2022
Sites	3 locations across United States

Drugs / interventions tested

pembrolizumab (pembrolizumab) — full drug profile →
Azacitadine — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 18 to 65, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximal Tolerable Dose of Pembrolizumab for Cohort 1
Time frame: 3- 28 day cycles
The primary objective is to determine the safe and tolerable dose for both the relapsed/refractory AML patients.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
T-cell-based immunotherapy of acute myeloid leukemia: current concepts and future developments.
Daver N, Alotaibi AS, Bücklein V, Subklewe M. · · 2021 · cited 178× · PMID 33953290 · DOI 10.1038/s41375-021-01253-x
Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
Study and analysis of antitumor resistance mechanism of PD1/PD-L1 immune checkpoint blocker.
Wang Z, Wu X. · · 2020 · cited 147× · PMID 32875727 · DOI 10.1002/cam4.3410
Combining epigenetic and immune therapy to overcome cancer resistance.
Gomez S, Tabernacki T, Kobyra J, Roberts P, et al · · 2020 · cited 130× · PMID 31877341 · DOI 10.1016/j.semcancer.2019.12.019
Dysregulated haematopoietic stem cell behaviour in myeloid leukaemogenesis.
Yamashita M, Dellorusso PV, Olson OC, Passegué E. · · 2020 · cited 128× · PMID 32415283 · DOI 10.1038/s41568-020-0260-3
Recent developments in immunotherapy of acute myeloid leukemia.
Lichtenegger FS, Krupka C, Haubner S, Köhnke T, et al · · 2017 · cited 103× · PMID 28743264 · DOI 10.1186/s13045-017-0505-0
Targeting the Immune Microenvironment in Acute Myeloid Leukemia: A Focus on T Cell Immunity.
Lamble AJ, Lind EF. · · 2018 · cited 95× · PMID 29951373 · DOI 10.3389/fonc.2018.00213

Verify or expand the search:

Other trials of pembrolizumab

Trials testing the same drug.

NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06899126 — Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-sm · Phase 3 · recruiting
NCT06161545 — Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcino · Phase 2 · recruiting
NCT05879484 — Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Ca · Phase 1, PHASE2 · withdrawn
NCT06682806 — A Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 · Phase 2 · terminated

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02845297 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 7 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02845297.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing