Actively Recruiting
Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma
Led by NYU Langone Health · Updated on 2026-01-05
105
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Willing and able to follow study visits, treatment, lab tests, and biopsies
- Diagnosed with unresectable Stage IIIb/c/d or Stage IV melanoma confirmed by biopsy
- Melanomas allowed except ocular/uveal melanoma; mucosal melanomas included
- No prior anticancer treatment for metastatic disease except surgery, brain radiotherapy for CNS metastases, local radiation, or certain prior adjuvant treatments
- Disease status documented by physical exam and imaging within 4 weeks before study drug start
- Disease measurable by RECIST 1.1 criteria
- Complete baseline imaging available before treatment
You will not qualify if you...
- Untreated brain metastases, carcinomatosis meningitis, or current ocular/uveal melanoma
- Previous non-melanoma cancers unless fully resected or in remission for at least 2 years without ongoing therapy
- Active, known, or suspected autoimmune disease requiring systemic treatment
- Use of systemic corticosteroids (> 10 mg prednisone daily or equivalent) or immunosuppressive drugs within 14 days before study drug
- Exceptions allowed for type I diabetes, hypothyroidism needing hormone replacement, and certain skin disorders not needing systemic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
The Angeles Clinic at Cedars Sinai
Los Angeles, California, United States, 90025
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
J
Janice Mehnert, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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