Spots Global Cancer Trial Database for Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML
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Trial Identification
Brief Title: Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML
Official Title: 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
Study ID: NCT04913922
Conditions
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital, LMU Munich, Munich, , Germany
Contact Details
Name: Marion Subklewe, MD
Affiliation: Department of Medicine III, University of Munich
Role: PRINCIPAL_INVESTIGATOR
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