An Open-Label Phase II Study of Relatlimab (BMS-986016) With Nivolumab (BMS-936558) in Combination With 5-Azacytidine for the Treatment of Patients With Refractory/Relapsed Acute Myeloid Leukemia and Newly Diagnosed Older Acute Myeloid Leukemia Patients
The ongoing Phase II clinical trial investigates the combination of relatlimab (Anti-LAG3), nivolumab (Anti-PD1), and 5-azacytidine in patients with refractory/relapsed Acute Myeloid Leukemia (AML) and newly diagnosed older AML patients. Given the high unmet medical need in AML, particularly among older patients who are often unfit for intensive therapies, successful outcomes could position this combination therapy as a novel treatment option in a competitive landscape dominated by traditional chemotherapeutics and emerging immunotherapies. The trial's focus on safety and tolerability, alongside efficacy measures like objective response rate (ORR), will be critical for future regulatory submissions and market access strategies. The study is being conducted by Ludwig-Maximilians University of Munich, which may enhance credibility and attract potential partnerships or investments.
Indication: Acute Myeloid Leukemia
Modality: small molecule
Target: PD-1 and LAG-3 immune checkpoint pathways
Sponsor: Ludwig-Maximilians - University of Munich
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 09, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: PD-1 and LAG-3 immune checkpoint pathways
View original source fields
Condition raw: Acute Myeloid Leukemia
Condition normalized: Acute Myeloid Leukemia
Modality raw: small molecule
Modality normalized: small molecule
Target raw: PD-1 and LAG-3 immune checkpoint pathways
Target normalized: PD-1 and LAG-3 immune checkpoint pathways