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Monoclonal Antibodies
Sarilumab + Immunotherapy for Melanoma
Phase 2
Recruiting
Led By Jeffrey Weber, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients must be either Stage IIIb/c/d or Stage IV according to the American Joint Committee on Cancer (AJCC) (8th edition) and have histologically-confirmed melanoma that is felt to be surgically unresectable in order to be eligible
Be older than 18 years old
Must not have
Patients with untreated brain metastases, carcinomatosis meningitis, or current ocular/uveal melanoma are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 31
Awards & highlights
Summary
This trial will test the safety and effectiveness of a new drug combination for advanced melanoma. The new drug, sarilumab, will be given with ipilimumab, nivolumab, and relatlimab to see if it is safe and if it works better than other treatments.
Who is the study for?
This trial is for adults with advanced melanoma (Stage IIIb/c/d or Stage IV) that can't be surgically removed. Participants must not have had previous treatments for metastatic melanoma, except under certain conditions. They should be able to follow the study plan and provide consent. People with brain metastases, another type of melanoma, other cancers within the last 2 years, or autoimmune diseases are excluded.Check my eligibility
What is being tested?
The trial tests Sarilumab combined with Ipilimumab, Nivolumab, and Relatlimab in patients with unresectable advanced melanoma. While Sarilumab is approved for rheumatoid arthritis but not yet for melanoma, Ipilimumab and Nivolumab are FDA-approved for this cancer stage; however, their combination here is investigational.See study design
What are the potential side effects?
Potential side effects include immune system reactions affecting organs (like inflammation), infusion-related responses such as fever or chills, fatigue from treatment burden on the body's energy resources, digestive issues like nausea or diarrhea due to gastrointestinal tract involvement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is at Stage IIIb/c/d or IV and cannot be removed with surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have untreated brain metastases, carcinomatosis meningitis, or current ocular/uveal melanoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 31
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 31
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Grades 3-5 Treatment-Related Immune-Related Adverse Events (irAE) per NCI CTCAE v 5.0 Criteria
Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Category
Secondary outcome measures
Best overall response (iBOR)
Disease Control Rate (DCR)
Duration of Immune-related Disease Control
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Study GroupExperimental Treatment3 Interventions
Participants receive sarilumab at 150 mg flat dose is administered subcutaneously every 2 weeks for 12 doses from day 1, cycle 1 in combination with a regimen of ipilimumab at 1 mg/kg every 8 weeks and fixed dose nivolumab at 480 mg and relatlimab at 160 mg flat dose every 4 weeks two times during the 8-week induction period, then the same regimen again up to week 16, and up to week 24 in maintenance. After week 24 the regimen will be ipilimumab at 1 mg/kg every 8 weeks and fixed dose nivolumab at 480 mg with relatlimab at 160 mg flat dose every 4 weeks for 8 week cycles for up to a total of 2 years in patients with unresectable Stage III/Stage IV melanoma.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Sarilumab
FDA approved
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
848,049 Total Patients Enrolled
11 Trials studying Melanoma
285 Patients Enrolled for Melanoma
Jeffrey Weber, MD, PhDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Melanoma
12 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's schedule and requirements.You have a known autoimmune disease that is currently active or suspected, unless you have specific conditions that are allowed.I have signed the consent form for this study.I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.I haven't had any treatment for cancer that has spread, with some exceptions.The disease must be able to be measured using a specific set of guidelines called RECIST 1.1.My melanoma is at Stage IIIb/c/d or IV and cannot be removed with surgery.I have melanoma, but it's not in my eye.My cancer's current state is confirmed by recent exams and scans.I do not have untreated brain metastases, carcinomatosis meningitis, or current ocular/uveal melanoma.I had cancer other than melanoma, was treated successfully over 2 years ago, and don't need more treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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