A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) (MK-0482-002)

  • STATUS
    Recruiting
  • End date
    May 30, 2024
  • participants needed
    30
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 15 March 2022

Summary

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). Part 2 is a dose expansion in the same relapsed/refractory (R/R) AML subtypes as in Part 1.

Details
Condition Relapsed or Refractory Acute Myeloid Leukemia
Treatment MK-0482
Clinical Study IdentifierNCT05038800
SponsorMerck Sharp & Dohme Corp.
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Has active central nervous system (CNS) leukemia
Has diagnosis of acute promyelocytic leukemia
Has isolated extramedullary disease, i.e., no leukemic involvement in bone marrow or
peripheral blood
Has an active uncontrolled infection requiring directed therapy
Has received previous allogeneic stem cell transplant or organ transplant within 60
days of screening
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 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 28 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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