A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)
Start Date
6/30/2026
Completion Date
6/1/2032
Summary
Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy. Pivekimab sunirine is a drug being evaluated in the treatment of AML.This is a Phase 2/Phase 3, study of PVEK. Phase 2 is open-label and randomized. Phase 3 is double-blind, randomized. Phase 2 and Phase 3 studies test potential new treatments in patients with a condition or disease. Open-label means that both patients and study doctors know which study treatment is given to patients in Phase 2 of the study. Double-blind means that neither the patients nor the study doctors know who is given which study treatment in Phase 3 of the study. Approximately 660 adult participants will be enrolled in 180 sites worldwide. In Phase 2 of the study, patients will be randomized to receive PVEK + VEN + AZA or standard of care treatment with VEN + AZA. In Phase 3, patients will be randomized to receive PVEK + VEN + AZA or a matching-placebo for PVEK plus VEN + AZA. PVEK is given as an infusion into the vein, AZA is given as an injection under your skin (subcutaneous) or as an infusion into the vein (intravenous) (depending on country where patient enrolls), and VEN is a tablet given by mouth. The total study duration is approximately 71 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pivekimab Sunirine
Venetoclax
Azacitidine
Matching Placebo for PVEK
Conditions
Locations
City of Hope National Medical Center /ID# 279568
Duarte, California 91010
United States
Moffitt Cancer Center /ID# 279192
Tampa, Florida 33612
United States
Winship Cancer Institute of Emory University /ID# 279006
Atlanta, Georgia 30322
United States
Washington University /ID# 280295
St Louis, Missouri 63110
United States
Montefiore Medical Center - Moses Campus /ID# 279399
The Bronx, New York 10467
United States
The University of Texas MD Anderson Cancer Center /ID# 279402
Houston, Texas 77030
United States
Universitaetsklinikum St. Poelten /ID# 278835
Sankt Pölten, Lower Austria 3100
Austria
Hanusch-Krankenhaus /ID# 279467
Vienna, State of Vienna 1140
Austria
Medizinische Universitaet Graz /ID# 278830
Graz, Styria 8010
Austria
Ordensklinikum Linz Elisabethinen /ID# 278824
Linz, Upper Austria 4010
Austria
Medizinische Universitaet Wien /ID# 278825
Vienna, 1090
Austria
Institut Paoli-Calmettes /ID# 279015
Marseille, Bouches-du-Rhone 13273
France
Centre Hospitalier Universitaire de Bordeaux /ID# 279001
Pessac, New Aquitaine 33604
France
Centre Hospitalier Universitaire D'Angers /ID# 280390
Angers, Pays de la Loire Region 49933
France
CHU Amiens-Picardie Site Sud /ID# 280716
Amiens, Somme 80054
France
Rabin Medical Center /ID# 278714
Petah Tikva, Central District 4941492
Israel
Tel Aviv Sourasky Medical Center /ID# 278717
Tel Aviv, Tel Aviv 6423906
Israel
Rambam Health Care Campus- Haifa /ID# 278719
Haifa, 3109601
Israel
Shaare Zedek Medical Center /ID# 278712
Jerusalem, 9103102
Israel
Hadassah Medical Center-Hebrew University /ID# 278866
Jerusalem, 91120
Israel
Seoul National University Bundang Hospital /ID# 279634
Seongnam-si, Gyeonggido 13620
South Korea
Seoul National University Hospital /ID# 279396
Seoul, Seoul Teugbyeolsi 03080
South Korea
Yonsei University Health System Severance Hospital /ID# 279933
Seoul, Seoul Teugbyeolsi 03722
South Korea
Asan Medical Center /ID# 279395
Seoul, Seoul Teugbyeolsi 05505
South Korea
Samsung Medical Center /ID# 279397
Seoul, Seoul Teugbyeolsi 06351
South Korea
Hospital Universitario Puerta De Hierro /ID# 279660
Majadahonda, Madrid 28222
Spain
Clinica Universidad de Navarra - Pamplona /ID# 279516
Pamplona, Navarre 31008
Spain
Hospital Universitario Virgen del Rocio /ID# 279471
Seville, Sevilla 41013
Spain
Hospital General Universitario Gregorio Maranon /ID# 279479
Madrid, 28007
Spain
Md Anderson Cancer Center /ID# 279480
Madrid, 28033
Spain
Hospital Clinico Universitario de Valencia /ID# 279635
Valencia, 46010
Spain
China Medical University Hospital /ID# 279261
Taichung, 40447
Taiwan
Taichung Veterans General Hospital /ID# 279296
Taichung, 407
Taiwan
National Taiwan University Hospital /ID# 279289
Taipei, 100
Taiwan
Taipei Veterans General Hospital /ID# 281480
Taipei, 112
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 279294
Taoyuan City, 333
Taiwan