A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)
NCT ID: NCT05038800
Last Updated: 2025-05-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
13 participants
INTERVENTIONAL
2021-09-26
2023-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MK-0482 7.5 mg Q3W
Participants will receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for up to 35 cycles (approximately 24 months).
MK-0482
IV infusion
MK-0482 25 mg Q3W
Participants will receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
MK-0482
IV infusion
MK-0482 75 mg Q3W
Participants will receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
MK-0482
IV infusion
MK-0482 225 mg Q3W
Participants will receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
MK-0482
IV infusion
MK-0482 750 mg Q3W
Participants will receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
MK-0482
IV infusion
Interventions
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MK-0482
IV infusion
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has isolated extramedullary disease, i.e., no leukemic involvement in bone marrow or peripheral blood.
* Has diagnosis of acute promyelocytic leukemia or participants with known Philadelphia chromosome positive (Ph+) AML.
* Has received previous allogeneic stem cell transplant or organ transplant within 60 days of the start of study treatment.
* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 1 year.
* Has a history of any of the following cardiovascular conditions within 6 months of screening: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, coronary artery bypass graft, or pulmonary embolism; has New York Heart Association (NYHA) Class III or IV congestive heart failure.
* Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAB) and or any components of the study intervention, MK-0482.
* Has an active uncontrolled infection requiring directed therapy.
* Has immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, or disseminated intravascular coagulation.
* Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections, or is known to be positive for HBsAg/ Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) or hepatitis C antibody or Ribonucleic acid (RNA).
* Has known psychiatric or substance abuse disorders (verbally reported) that would interfere with the participant's ability to cooperate with the requirements of the study.
* Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
* Has received systemic anticancer therapy, radiotherapy, or surgery within 2 weeks before the start of study treatment.
* Has received hematopoietic cytokines (Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte Macrophage (GM)-CSF, or erythropoietin) within 2 weeks prior to start of study treatment.
* Has received a live or live attenuated vaccine within 30 days before the first dose of study medication.
* Is currently participating and receiving study intervention in a study of an investigational agent or has participated and received study intervention in a study of an investigational agent or has used an investigational device within 14 days of administration of MK-0482.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Roswell Park Cancer Institute ( Site 0006)
Buffalo, New York, United States
University of Texas MD Anderson Cancer Center ( Site 0004)
Houston, Texas, United States
Hadassah Medical Center ( Site 0100)
Jerusalem, , Israel
Sheba Medical Center-Hemato Oncology ( Site 0101)
Ramat Gan, , Israel
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0301)
Salamanca, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-0482-002
Identifier Type: OTHER
Identifier Source: secondary_id
2023-003740-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1287-5269
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-003740-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0482-002
Identifier Type: -
Identifier Source: org_study_id
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