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An Open-Label Phase I/II Study of Relatlimab (BMS-986016) with Nivolumab (BMS-936558) in Combination with 5-Azacytidine for Relapsed/Refractory Acute Myeloid Leukemia and in Combination with 5-Azacytidine and Venetoclax for Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Negative for NPM1 and IDH 1/2 Mutations Who Are Ineligible for Intensive Chemotherapy (AARON)
EU CTIS ID: 2024-514948-89-00
What this study is testing
Lead-in phase I: To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of relatlimab in combination with nivolumab and 5-azacytidine in patients with relapsed/refractory (R/R) AML. To determine the MTD and DLT of relatlimab in combination with nivolumab, 5-azacytidine and venetoclax in frontline non-fit AML patients Expansion phase II: To estimate the overall response rate (ORR) to treatment with relatlimab + nivolumab + 5-azacytidine in patients with R/R AML. To estimate the ORR to treatment with relatlimab + nivolumab + 5-azacytidine + venetoclax in frontline non-fit AML patients
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 CR, CRi, or CRp, or patients who have failed up to one prior salvage therapy.
- At least 2 weeks OR at least 5 half-lives interval from prior treatment to time of initiation of study medication.
- Written informed consent.
- GvHD of grade ≤A on ≤10 mg prednisone without any additional immunosuppressive therapies (tacrolimus, ciclosporin, etc.).
- Negative pregnancy test and adequate methods of contraception for females of childbearing potential, adequate methods of contraception for males.
- Cohort 2 (frontline non-fit AML): Patients with previously untreated AML, negative for mutations in NPM1 and IDH 1/2 genes, who are ineligible for or decline standard induction therapy.
You likely can't join if
- Acute promyelocytic leukemia (APL).
- 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.
See the full eligibility 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 CR, CRi, or CRp, or patients who have failed up to one prior salvage therapy.
- At least 2 weeks OR at least 5 half-lives interval from prior treatment to time of initiation of study medication.
- Written informed consent.
- GvHD of grade ≤A on ≤10 mg prednisone without any additional immunosuppressive therapies (tacrolimus, ciclosporin, etc.).
- Negative pregnancy test and adequate methods of contraception for females of childbearing potential, adequate methods of contraception for males.
- Cohort 2 (frontline non-fit AML): Patients with previously untreated AML, negative for mutations in NPM1 and IDH 1/2 genes, who are ineligible for or decline standard induction therapy.
- Patients not eligible for intensive induction chemotherapy and/or allogeneic stem cell transplant.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- Age ≥18 years.
- Total bilirubin ≤2 x upper limit of normal (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%.
- Acute promyelocytic leukemia (APL).
- 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.
- Biphenotypic or bilineage leukemia.
- 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.
- Known allergy or hypersensitivity to 5-azacytidine, nivolumab, relatlimab, or any of their components.
- Known allergy or hypersensitivity to venetoclax, or any of its components, for patients in Cohort 2.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.