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NCT05629546 · ClinicalTrials.gov registry record · Phase 1
Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
A Phase 1 study of Metastatic Melanoma and Advanced Melanoma, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT05629546: Recruiting Phase 1 study of Metastatic Melanoma and Advanced Melanoma, sponsored by Washington University School of Medicine.
NCT05629546 is a Phase 1 study of Metastatic Melanoma and Advanced Melanoma that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 33 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05629546, a Phase 1 study of Metastatic Melanoma and Advanced Melanoma, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.
Primary Outcome
-As determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Cytokine-induced memory-like natural killer cells
- BIOLOGICAL Relatilmab
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2024-11-06 |
| Est. Completion | 2030-11-30 |
| Phase | Phase 1 |
What NCT05629546 shows while recruiting
NCT05629546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05629546 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05629546 about?
NCT05629546 is a clinical study titled "Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors". This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the...
What is the current status of trial NCT05629546?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2024-11-06. Estimated completion is 2030-11-30.
What conditions does trial NCT05629546 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Advanced Melanoma.
What interventions are being tested in trial NCT05629546?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Cytokine-induced memory-like natural killer cells (BIOLOGICAL), Relatilmab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05629546?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05629546 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05629546's enrollment target sits among peer trials
33 53rd of 91 higher than 38 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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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