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NCT05382325 · ClinicalTrials.gov registry record · Phase 1
A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001)
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 8
- Study locations
NCT05382325: Active Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Merck Sharp & Dohme.
NCT05382325 is a Phase 1 study of Advanced or Metastatic Solid Tumors that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 70 participants, below the 233-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (70% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05382325, a Phase 1 study of Advanced or Metastatic Solid Tumors, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to assess the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-1484 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adults with advanced or metastatic solid tumors.
Primary Outcome
DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment: Grade (Gr) 4 nonhematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia: Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with clinically significant bleeding; Gr 4 anemia regardless of duration; Nonhematologic AE Gr ≥3 in severity, with exceptions; Any Gr 3 or 4 nonhematologic laboratory abnormality if: clin
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-1484
Study Locations (8)
Other
- Rambam Health Care Campus-Oncology ( Site 0021) - Haifa
- Sheba Medical Center-ONCOLOGY ( Site 0020) - Ramat Gan
- Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0037) - Utrecht
South Dakota
- Sanford Cancer Center ( Site 0005) - Sioux Falls
Texas
- NEXT Oncology ( Site 0001) - San Antonio
Ontario
- Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0011) - Toronto
North Holland
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0035) - Amsterdam
South Holland
- Erasmus Medisch Centrum-Medical Oncology ( Site 0036) - Rotterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-06-16 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What the registry record for NCT05382325 still lists
NCT05382325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 233-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05382325 lists 8 locations in 6 states (Other, South Dakota, Texas).
Frequently Asked Questions
What is clinical trial NCT05382325 about?
NCT05382325 is a clinical study titled "A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001)". The purpose of this study is to assess the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-1484 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adults with advanced or metastatic solid tumors.
What is the current status of trial NCT05382325?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2022-06-16. Estimated completion is 2026-07-31.
What conditions does trial NCT05382325 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT05382325?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-1484 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05382325?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05382325 being conducted?
This trial has 8 study locations across South Dakota, Texas, Ontario, North Holland, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05382325's enrollment target sits among peer trials
70 20th of 19 the lowest of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors 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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