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
Mayo Clinic Hospital - Phoenix /ID# 282904
Phoenix, Arizona 85054
United States
City of Hope National Medical Center /ID# 279568
Duarte, California 91010
United States
Mayo Clinic Hospital Jacksonville /ID# 282903
Jacksonville, Florida 32224
United States
Montefiore Medical Center - Moses Campus /ID# 279399
The Bronx, New York 10467
United States
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
Samsung Medical Center /ID# 279397
Seoul, Seoul Teugbyeolsi 06351
South Korea
China Medical University Hospital /ID# 279261
Taichung, 40447
Taiwan
Taichung Veterans General Hospital /ID# 279296
Taichung, 407
Taiwan