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

Who is this study for? Patients with refractory/relapsed acute myeloid leukemia and older patients with newly diagnosed acute myeloid leukemia
What treatments are being studied? Azacitidine+Nivolumab+Relatlimab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Cohort 1 (R/R AML):

⁃ \- Patients with AML who have failed first line induction chemotherapy (consisting of a minimum of two intensive chemotherapy cycles, e.g. 7+3 or HAM) or patients with AML who have relapsed after achieving complete remission (CR), CRi, or CRp, or patients who have failed up to one prior salvage therapy

⁃ Cohort 2 (frontline older AML):

⁃ \- Patients aged ≥65 years with previously untreated AML who are unfit for or decline standard induction therapy.

• Patients not eligible for intensive induction chemotherapy and/or allogeneic stem cell transplant.

• Age ≥18 years

• ECOG Performance Status ≤2

• Adequate organ function:

⁃ Total bilirubin ≤2 x ULN (≤3 × ULN if due to leukemic involvement or Gilbert's syndrome) AST and ALT ≤2.5 × ULN (≤5.0 × ULN if due to leukemic involvement) Serum creatinine ≤2 × ULN or glomerular filtration rate (GFR) ≥50 mL/h

• Adequate cardiac function: TTE with documented LVEF ≥50%

• At least 2 weeks OR at least 5 half-lives interval from prior treatment to time of initiation of study medication

• GvHD of grade ≤A on ≤10 mg prednisone without any additional immunosuppressive therapies (tacrolimus, ciclosporin, etc.)

• Written informed consent

• Negative pregnancy test and adequate methods of contraception for females of childbearing potential, adequate methods of contraception for males

Locations
Other Locations
Germany
University Hospital, LMU Munich
RECRUITING
Munich
Contact Information
Primary
Marion Subklewe, MD
marion.subklewe@med.uni-muenchen.de
+498944000
Backup
Veit Bücklein, MD
veit.buecklein@med.uni-muenchen.de
+498944000
Time Frame
Start Date: 2021-05-05
Estimated Completion Date: 2026-03
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Ludwig-Maximilians - University of Munich

This content was sourced from clinicaltrials.gov