Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML
Status:
Recruiting
Trial end date:
2026-03-31
Target enrollment:
Participant gender:
Summary
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).