OncoMatch/Clinical Trials/NCT04913922
Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML
Is NCT04913922 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Nivolumab for acute myeloid leukemia.
Treatment: Azacitidine · Nivolumab · Relatlimab — The clinical trial will test the safety and tolerability of a combination therapy (azacitidine in combination with two checkpoint inhibitors, nivolumab \[Anti-PD1\] and relatlimab \[Anti-LAG3\]) in patients with relapsed/refractory Acute Myeloid Leukemia (AML) and patients ≥ 65 years with initial diagnosis of AML. Primary objectives are: * maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of the combination therapy during the lead-in phase of the clinical trial (6-12 patients) and * objective response rate (ORR) of the combination therapy in the phase II part of the study (up to 24 patients).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive chemotherapy (7+3, HAM) — induction
failed first line induction chemotherapy (consisting of a minimum of two intensive chemotherapy cycles, e.g. 7+3 or HAM)
Cannot have received: immunotherapeutic drugs targeting PD-1/PD-L1 in combination with 5-azacytidine
Previous treatment with immunotherapeutic drugs targeting PD-1/PD-L1 in combination with 5-azacytidine
Cannot have received: LAG-3 targeted agents
Previous treatment with LAG-3 targeted agents
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: allowed if >100 days before first study drug administration
Allogeneic hematopoietic stem cell transplantation within the last 100 days before first study drug administration
Lab requirements
Kidney function
Serum creatinine ≤2 × ULN or glomerular filtration rate (GFR) ≥50 mL/h
Liver function
Total bilirubin ≤2 x ULN (≤3 × ULN if due to leukemic involvement or Gilbert's syndrome); AST and ALT ≤2.5 × ULN (≤5.0 × ULN if due to leukemic involvement)
Cardiac function
TTE with documented LVEF ≥50%; Troponin T (TnT) or I (TnI) > 2 × institutional ULN [excluded]; Uncontrolled or significant cardiovascular disease [excluded]
Adequate organ function: Total bilirubin ≤2 x ULN (≤3 × ULN if due to leukemic involvement or Gilbert's syndrome) AST and ALT ≤2.5 × ULN (≤5.0 × ULN if due to leukemic involvement) Serum creatinine ≤2 × ULN or glomerular filtration rate (GFR) ≥50 mL/h; Adequate cardiac function: TTE with documented LVEF ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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