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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

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a combination of drugs, including one usually for arthritis and three for cancer. It targets patients with advanced melanoma that can't be surgically removed. The drugs help the immune system attack the cancer by blocking proteins that help the cancer grow.

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.

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.

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 31 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Best overall response (iBOR)

Disease Control Rate (DCR)

Duration of Immune-related Disease Control

+8 more

Awards & Highlights

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.

Trial 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

0 / 2Eligibility criteria met