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NCT05289193 · ClinicalTrials.gov registry record · Phase 2
CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma
A Phase 2 study of Melanoma and Melanoma Stage III, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 4
- Study locations
NCT05289193: Active Phase 2 study of Melanoma and Melanoma Stage III, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05289193 is a Phase 2 study of Melanoma and Melanoma Stage III that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 28 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05289193, a Phase 2 study of Melanoma and Melanoma Stage III, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 4
- Study locations
Study Summary
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.
Primary Outcome
Participants' disease will be assessed for MPR as per previously established criteria for neoadjuvant trials (near complete response ≤10% viable; complete response 0% viable). Pathologic response (≤50% viable) will also be estimated.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DIAGNOSTIC_TEST PET Scan
- PROCEDURE Surgical Resection of Melanoma
Study Locations (4)
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2026-03-11 |
| Phase | Phase 2 |
What the registry record for NCT05289193 still lists
NCT05289193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT05289193 reports a single indexed study location in New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT05289193 about?
NCT05289193 is a clinical study titled "CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma". Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery ...
What is the current status of trial NCT05289193?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2022-03-11. Estimated completion is 2026-03-11.
What conditions does trial NCT05289193 study?
This clinical trial studies the following conditions: Melanoma, Melanoma Stage III.
What interventions are being tested in trial NCT05289193?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), PET Scan (DIAGNOSTIC_TEST), Surgical Resection of Melanoma (PROCEDURE).
Who is sponsoring clinical trial NCT05289193?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05289193 being conducted?
This trial has 4 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05289193's enrollment target sits among peer trials
28 207th of 266 higher than 58 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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