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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)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514948-89-00
Acronym
CA224-065
Enrollment
30
Registered
2024-10-02
Start date
2021-01-27
Completion date
Unknown
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Brief summary

Lead-in phase I: MTD and DLT of relatlimab in combination with nivolumab and 5-azacytidine in patients with R/R AML., Lead-in phase I: MTD and DLT of relatlimab in combination with nivolumab and 5-azacytidine and venetoclax in frontline non-fit AML patients., Expansion phase II: ORR to treatment with relatlimab + nivolumab + 5- azacytidine in patients with R/R AML., Expansion phase II: ORR to treatment with relatlimab + nivolumab + 5- azacytidine + venetoclax in frontline non-fit AML patients.

Detailed description

% of grade I/II and grade III/IV toxicities for patients with R/R AML on therapy with relatlimab + nivolumab + 5- azacytidine., % of grade I/II and grade III/IV toxicities for frontline non-fit AML patients on therapy with relatlimab + nivolumab + 5- azacytidine + venetoclax., Number of patients with R/R AML who achieve a HI in platelets, hemoglobin, or ANC on therapy with relatlimab + nivolumab + 5-azacytidine., Number of patients with R/R AML who achieve ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine., Number of frontline non-fit AML patients who have an HI in platelets, hemoglobin, or ANC on therapy with relatlimab + nivolumab + 5-azacytidine + venetoclax., Number of frontline non-fit AML patients who have ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine + venetoclax., Duration of response, Disease-free survival (DFS), and Overall Survival (OS) of patients with R/R AML treated with relatlimab + nivolumab + 5-azacytidine., Duration of response, DFS, and OS in frontline non-fit AML patients treated with relatlimab + nivolumab + 5-azacytidine + venetoclax.

Interventions

DRUGVENETOCLAX
DRUGVidaza 25 mg/ml powder for suspension for injection
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGRELATLIMAB

Sponsors

Klinikum der Universitaet Muenchen AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Lead-in phase I: MTD and DLT of relatlimab in combination with nivolumab and 5-azacytidine in patients with R/R AML., Lead-in phase I: MTD and DLT of relatlimab in combination with nivolumab and 5-azacytidine and venetoclax in frontline non-fit AML patients., Expansion phase II: ORR to treatment with relatlimab + nivolumab + 5- azacytidine in patients with R/R AML., Expansion phase II: ORR to treatment with relatlimab + nivolumab + 5- azacytidine + venetoclax in frontline non-fit AML patients.—

Secondary

MeasureTime frame
% of grade I/II and grade III/IV toxicities for patients with R/R AML on therapy with relatlimab + nivolumab + 5- azacytidine., % of grade I/II and grade III/IV toxicities for frontline non-fit AML patients on therapy with relatlimab + nivolumab + 5- azacytidine + venetoclax., Number of patients with R/R AML who achieve a HI in platelets, hemoglobin, or ANC on therapy with relatlimab + nivolumab + 5-azacytidine., Number of patients with R/R AML who achieve ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine., Number of frontline non-fit AML patients who have an HI in platelets, hemoglobin, or ANC on therapy with relatlimab + nivolumab + 5-azacytidine + venetoclax., Number of frontline non-fit AML patients who have ≥50% reduction in blasts on therapy with relatlimab + nivolumab + 5-azacytidine + venetoclax., Duration of response, Disease-free survival (DFS), and Overall Survival (OS) of patients with R/R AML treated with relatlimab + nivolumab + 5-azacytidine—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026