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NCT05428007 · ClinicalTrials.gov registry record · Phase 2
Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma
A Phase 2 study of Melanoma and Unresectable Melanoma, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 4
- Study locations
NCT05428007: Recruiting Phase 2 study of Melanoma and Unresectable Melanoma, sponsored by NYU Langone Health.
NCT05428007 is a Phase 2 study of Melanoma and Unresectable Melanoma that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 105 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05428007, a Phase 2 study of Melanoma and Unresectable Melanoma, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will evaluate how safe the study drug is, how well patients tolerate it, how it works in the body, and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients like yourself, with stage III or stage IV melanoma that cannot be removed by surgery. Previous studies have provided a strong rationale for combining sarilumab, with ipilimumab, nivolumab and relatlimab in metastatic melanoma to reduce side effects and potentially work better for your type of cancer. Sarilumab is an FDA-approved inhibitor of the receptor for the cytokine IL-6, currently approved for the treatment of rheumatoid arthritis, but it is not FDA-approved to treat melanoma. This means that the use of Sarilumab to treat melanoma is considered investigational. The other drugs which will be administered in this study, ipilimumab and nivolumab, are also monoclonal antibodies, but they target different proteins. Ipilimumab and nivolumab are both approved by the FDA to treat advanced stage III and IV melanomas. The nivolumab + relatlimab FDC (fixed dose combination) being used in this study is considered investigational, meaning it is not approved by the FDA. The combination of sarilumab, ipilimumab, nivolumab and relatlimab is considered investigational because it has not yet been approved by the FDA. The FDA has given its permission to study the investigational combination of these drugs in this research study.
Primary Outcome
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) grades adverse events by the following scale: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death Safety will be measured by physical examinations, vital sign measurements, Eastern Cooperative Oncology Group (ECOG) performance status evaluations, AE assessments, laboratory testing, electrocardiograms (ECGs), oxygen saturation, and concomitant medication
Conditions Studied
Interventions
- DRUG Sarilumab
- DRUG Ipilimumab Injection
- DRUG Nivolumab/Relatlimab
Study Locations (4)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
California
- The Angeles Clinic at Cedars Sinai - Los Angeles
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2023-02-02 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What NCT05428007 shows while recruiting
NCT05428007 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Sarilumab is the first listed.
NCT05428007 reports a single indexed study location in Massachusetts, California, New York.
Frequently Asked Questions
What is clinical trial NCT05428007 about?
NCT05428007 is a clinical study titled "Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma". This study will evaluate how safe the study drug is, how well patients tolerate it, how it works in the body, and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients like yourself, with sta...
What is the current status of trial NCT05428007?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2023-02-02. Estimated completion is 2028-02.
What conditions does trial NCT05428007 study?
This clinical trial studies the following conditions: Melanoma, Unresectable Melanoma.
What interventions are being tested in trial NCT05428007?
The interventions under investigation include: Sarilumab (DRUG), Ipilimumab Injection (DRUG), Nivolumab/Relatlimab (DRUG).
Who is sponsoring clinical trial NCT05428007?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05428007 being conducted?
This trial has 4 study locations across California, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05428007's enrollment target sits among peer trials
105 108th of 266 higher than 159 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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