Clinical trial · Interventional
Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML
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
NCT04913922CI-TRIAL-00062073AARONunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine Injection | Drug | Azacitidine | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Relatlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination therapy
- description
- 5-azacitidine 75 mg/m2 body surface area s.c. for 7 days nivolumab 480mg i.v. day 1 relatlimab 80-160mg i.v. day 1 repeat day 28
- interventionNames
- Drug: Azacitidine Injection
- Drug: Nivolumab
- Drug: Relatlimab
Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- after completion of the first cycle in the fist 6-12 patients, approximately during the first 6-12 months of study conduct
- description
- To determine the MTD of relatlimab in combination with nivolumab and 5-azacytidine in patients with R/R AML.
- measure
- Dose-limiting toxicities (DLTs)
- timeFrame
- after completion of the first cycle in the fist 6-12 patients, approximately during the first 6-12 months of study conduct
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Cohort 1 (R/R AML): \- Patients with AML who have failed first line induction chemotherapy (consisting of a minimum of two intensive chemotherapy cycles, e.g. 7+3 or HAM) or patients with AML who have relapsed after achieving complete remission (CR), CRi, or CRp, or patients who have failed up to one prior salvage therapy Cohort 2 (frontline older AML): \- Patients aged ≥65 years with previously untreated AML who are unfit for or decline standard induction therapy. General inclusion criteria: * Patients not eligible for intensive induction chemotherapy and/or allogeneic stem cell transplant. * Age ≥18 years * ECOG Performance Status ≤2 * 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% * At least 2 weeks OR at least 5 half-lives interval from prior treatment to time of initiation of study medication * GvHD of grade ≤A on ≤10 mg prednisone without any additional immunosuppressive therapies (tacrolimus, ciclosporin, etc.) * Written informed consent * Negative pregnancy test and adequate methods of contraception for females of childbearing potential, adequate methods of contraception for males Exclusion Criteria: * Acute promyelocytic leukemia (APL) * Biphenotypic or bilineage leukemia * Known allergy or hypersensitivity to 5-azacytidine, nivolumab, relatlimab, or any of their components * History of life-threatening toxicity related to prior immune therapy * Previous treatment with immunotherapeutic drugs targeting PD-1/PD-L1 in combination with 5-azacytidine * Previous treatment with LAG-3 targeted agents * Known history of severe interstitial lung disease or severe pneumonitis * Known history (active, known, or suspected) of any of the following autoimmune diseases: inflammatory bowel disease rheumatoid arthritis systemic progressive sclerosis systemic lupus erythematosus autoimmune vasculitis * Active uncontrolled pneumonitis * Active uncontrolled infection * Symptomatic or poorly controlled CNS leukemia * Confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent * Uncontrolled or significant cardiovascular disease * Troponin T (TnT) or I (TnI) \> 2 × institutional ULN * Organ allografts * Allogeneic hematopoietic stem cell transplantation within the last 100 days before first study drug administration * Active GvHD \> grade A * Known human immunodeficiency virus seropositivity * Known positivity for hepatitis B by surface antigen expression or active hepatitis C infection * Other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety * Patients unwilling or unable to comply with the protocol * Patients who are pregnant or breastfeeding * Prisoners and subjects who are compulsory detained
References
Publications (0)
Data not yet available
No reference posted for this study.