Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
NCT ID: NCT05514444
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2022-09-25
2025-09-18
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-4464
Participants will receive an intravenous (IV) infusion of MK-4464 administered in escalating doses every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of previous dose.
MK-4464
MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.
MK-4464 + Pembrolizumab
Participants will receive an IV infusion of MK-4464 administered in escalating doses and a 200 mg IV infusion of Pembrolizumab every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of MK-4464 monotherapy arm.
MK-4464
MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.
Pembrolizumab
Pembrolizumab 200 mg administered as an IV infusion every three weeks.
MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464
Participants will receive an IV infusion of 89Zr-MK-4464 + IV infusion of MK-4464 on Cycle 1 Day 1, followed by an IV infusion of MK-4464 + a 200 mg IV infusion of pembrolizumab starting on Cycle 2 Day 1 and every 3 weeks for up to 35 cycles. Each cycle=3 weeks. MK-4464 doses will be based on safety of MK-4464 monotherapy arm. Participants may receive a 200 mg IV infusion of pembrolizumab on cycle 36.
MK-4464
MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.
Pembrolizumab
Pembrolizumab 200 mg administered as an IV infusion every three weeks.
89Zr-MK-4464
89ZR-MK-4464 administered as an IV infusion on C1D1.
Interventions
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MK-4464
MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.
Pembrolizumab
Pembrolizumab 200 mg administered as an IV infusion every three weeks.
89Zr-MK-4464
89ZR-MK-4464 administered as an IV infusion on C1D1.
Eligibility Criteria
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Inclusion Criteria
* Must submit a baseline tumor sample for analysis
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.
Exclusion Criteria
* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
* Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active infection requiring therapy
* History of an allogenic stem cell transplant or a solid organ transplant
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study
* Has not fully recovered from any effects of major surgery without significant detectable infection
* Has received radiation therapy to the lung that is \>30 gray (Gy) within 6 months of the first dose of study treatment
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* 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
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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The University of Louisville, James Graham Brown Cancer Center ( Site 0100)
Louisville, Kentucky, United States
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201)
Toronto, Ontario, Canada
Rambam Health Care Campus-Oncology Division ( Site 0300)
Haifa, , Israel
Hadassah Medical Center-Oncology ( Site 0302)
Jerusalem, , Israel
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0401)
Amsterdam, North Holland, Netherlands
Amsterdam UMC, locatie VUmc ( Site 0400)
Amsterdam, North Holland, Netherlands
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-4464-001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504855-28-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-2697
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-005882-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
4464-001
Identifier Type: -
Identifier Source: org_study_id
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