A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Buffalo and Houston, United StatesSee the 2 sitesAlso in 2 other countries, 3 sites
- Trial code
- NCT05038800
- EudraCT 2022-003740-27
- U1111-1287-5269
- Status
- Terminated
- Phase
- Phase 1
- People taking part
- 13 people enrolled
- Started
- 26 Sept 2021
- Ended
- 11 Dec 2023
- Type of study
- Interventional, 5 groups
- Treatments tested
- MK-0482
- Record updated
- 21 May 2025
- Why it stopped
- Business Reasons
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- -Has confirmed diagnosis of AML with myelomonocytic or monoblastic/monocytic differentiation per World Health Organization (WHO) 2016 criteria and with confirmed refractory or relapsed disease (i.e., ≥5% blast in bone marrow or in peripheral blood) after treatment with available therapies known to benefit participant's AML subtypes or has a known diagnosis of CMML per WHO criteria [2017] with confirmed refractory or released disease after treatment with available therapies known to be active for CMML
Who cannot take part
- Has received previous allogeneic stem cell transplant or organ transplant within 60 days of the start of study treatment
- Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAB) and or any components of the study intervention, MK-0482
- 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
- Has isolated extramedullary disease, i.e., no leukemic involvement in bone marrow or peripheral blood
- 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 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
- Has active central nervous system (CNS) leukemia
- Has diagnosis of acute promyelocytic leukemia or participants with known Philadelphia chromosome positive (Ph+) AML
- 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
Where in United States
Also in 2 other countries, 3 sites
- Roswell Park Cancer Institute (Site 0006)Buffalo, United StatesNo longer taking part
- University of Texas MD Anderson Cancer Center (Site 0004)Houston, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and recommended Phase 2 dose (RP2D) of MK-0482. There are 2 parts of this study. Part 1 is a dose escalation which will follow an accelerated titration design (ATD) for participants with relapsed/refractory (R/R) AML or CMML. Part 2 is a dose expansion for participants with R/R AML.
The 5 groups in the trial
- MK-0482 7.5 mg Q3WTreatment being tested
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).
Treatment: MK-0482
- MK-0482 25 mg Q3WTreatment being tested
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).
Treatment: MK-0482
- MK-0482 75 mg Q3WTreatment being tested
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).
Treatment: MK-0482
- MK-0482 225 mg Q3WTreatment being tested
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).
Treatment: MK-0482
- MK-0482 750 mg Q3WTreatment being tested
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).
Treatment: MK-0482
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of MK-0482 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
- Record updated
- 21 May 2025