RecruitingPhase 2NCT04913922

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

Sponsor

Ludwig-Maximilians - University of Munich

Enrollment

30 participants

Start Date

May 5, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — relatlimab, nivolumab, and azacitidine — for people with acute myeloid leukemia (AML), a blood cancer. The combination aims to use the immune system to fight leukemia cells that have stopped responding to standard chemotherapy. **You may be eligible if:** - You have AML that did not respond to or came back after standard chemotherapy - You are 65 or older with newly diagnosed AML and are not able to tolerate intense chemotherapy - You are 18 or older with reasonably good overall health (able to carry out light activity) - Your heart, kidney, and liver are functioning adequately **You may NOT be eligible if:** - You have a specific type of leukemia called acute promyelocytic leukemia (APL) - You have had severe reactions to immunotherapy in the past - You have active autoimmune diseases (like lupus, rheumatoid arthritis, or inflammatory bowel disease) - You have active hepatitis B, hepatitis C, or HIV - You have received a stem cell transplant within the last 100 days - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine Injection

s.c. 75 mg/m2 BSA for 7 days

DRUGNivolumab

480 mg i.v.

DRUGRelatlimab

80-160mg i.v.

Locations(1)

University Hospital, LMU Munich

Munich, Germany

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NCT04913922

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