Relatlimab, Nivolumab and 5-Azacytidine in Patients with AM

Phase 1

• Conditions: Subjects with Acute myeloid leukemia; MedDRA version: 20.0Level: LLTClassification code 10001941Term: AMLSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002939-21-DE
• Lead Sponsor: Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-04
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Cohort 1 (R/R AML):
• Patients with AML who have failed first line therapy (other than hydroxyurea) or patients who have relapsed after achieving a CR, CRp, or CRi.
• Patients with AML who have failed up to one prior salvage therapy (i.e. salvage 1 or 2 status) will also be eligible. Allogeneic stem cell transplant for patients in remission at the time of transplant will not be considered a salvage regimen. Hydroxyurea if used alone will not be considered a salvage regimen.
Cohort 2 (frontline older AML):
• Patients aged =65 years with previously untreated AML who are unfit for or decline standard induction therapy.
• Prior therapy with hydroxyurea, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however, prior therapy with chemotherapy agents for the disease under study is not allowed.
All Cohorts:
• Age =18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status =2
• Adequate organ function
• Patients must provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

• Patients with APL.
• Patients with known allergy or hypersensitivity to nivolumab, 5-azacytidine, relatlimab, or any
of their components.
• Patients with a history of life-threatening toxicity related to prior immune therapy (e.g. anti- CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (e.g., hormone replacement after endocrinopathy).
• Patients who have previously been treated with immunotherapeutic drugs targeting PD-1/PD-L1 in combination with 5-azacytidine.
• Patients who have previously been treated with LAG-3 targeted agents.
• Patients with a known history of severe interstitial lung disease or severe pneumonitis.
• Patients with an active, known or suspected history of any autoimmune disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified