Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML

Sponsor
Ludwig-Maximilians - University of Munich
Study ID
NCT04913922
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine Injection — DRUG
    s.c. 75 mg/m2 BSA for 7 days
  • Nivolumab — DRUG
    480 mg i.v.
  • Relatlimab — DRUG
    80-160mg i.v.

Study Details

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).

Key Dates

Start date
May 5, 2021
Status verified
Nov 2022
Primary completion
Mar 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination therapy
    5-azacitidine 75 mg/m2 body surface area s.c. for 7 days nivolumab 480mg i.v. day 1 relatlimab 80-160mg i.v. day 1 repeat day 28

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: after completion of the first cycle in the fist 6-12 patients, approximately during the first 6-12 months of study conduct ]

Central Contacts

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