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

NCT04913922 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-08

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Azacitidine Injection

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

DRUG

Nivolumab

480 mg i.v.

DRUG

Relatlimab

80-160mg i.v.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Marion Subklewe, MD · Department of Medicine III, University of Munich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2025-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04913922 on ClinicalTrials.gov