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NCT05514444 · ClinicalTrials.gov registry record · Phase 1
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
A Phase 1 study of Neoplasms and Advanced/Metastatic Solid Tumors, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 6
- Study locations
NCT05514444: Completed Phase 1 study of Neoplasms and Advanced/Metastatic Solid Tumors, sponsored by Merck Sharp & Dohme.
NCT05514444 is a Phase 1 study of Neoplasms and Advanced/Metastatic Solid Tumors that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 64 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05514444, a Phase 1 study of Neoplasms and Advanced/Metastatic Solid Tumors, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.
Primary Outcome
A DLT is any toxicity assessed by the investigator to be possibly, probably, or definitely related to study intervention administration that results in a change to a given dose or a delay in initiating the next cycle. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-4464
- DRUG 89Zr-MK-4464
Study Locations (6)
Other
- Rambam Health Care Campus-Oncology Division ( Site 0300) - Haifa
- Hadassah Medical Center-Oncology ( Site 0302) - Jerusalem
North Holland
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0401) - Amsterdam
- Amsterdam UMC, locatie VUmc ( Site 0400) - Amsterdam
Kentucky
- The University of Louisville, James Graham Brown Cancer Center ( Site 0100) - Louisville
Ontario
- Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201) - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2022-09-25 |
| Est. Completion | 2025-09-18 |
| Phase | Phase 1 |
What the finished NCT05514444 record still lists
NCT05514444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05514444 lists 6 locations in 4 states (Other, North Holland, Kentucky).
Frequently Asked Questions
What is clinical trial NCT05514444 about?
NCT05514444 is a clinical study titled "Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)". The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.
What is the current status of trial NCT05514444?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2022-09-25. Estimated completion is 2025-09-18.
What conditions does trial NCT05514444 study?
This clinical trial studies the following conditions: Neoplasms, Advanced/Metastatic Solid Tumors.
What interventions are being tested in trial NCT05514444?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-4464 (BIOLOGICAL), 89Zr-MK-4464 (DRUG).
Who is sponsoring clinical trial NCT05514444?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05514444 being conducted?
This trial has 6 study locations across Kentucky, Ontario, North Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05514444's enrollment target sits among peer trials
64 92nd of 158 higher than 66 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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