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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 31

Awards & highlights

Study 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 below

Select...

My melanoma is at Stage IIIb/c/d or IV and cannot be removed with surgery.

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

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 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,657 Total Patients Enrolled

11 Trials studying Melanoma

286 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

Ipilimumab Injection (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05428007 — Phase 2

Melanoma Research Study Groups: Study Group

Melanoma Clinical Trial 2023: Ipilimumab Injection Highlights & Side Effects. Trial Name: NCT05428007 — Phase 2

Ipilimumab Injection (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05428007 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What end goals are being examined in this scientific endeavor?

"The primary endpoint of this medical trial, evaluated over a 24-day (+/-7 days) time frame, is the number of Treatment-Related Grade 3 to 5 Immune Adverse Events (irAEs) according to NCI CTCAE v5.0 standards. Other outcomes include the Immune Response Rate (irRR), Disease Control Rate (DCR), and Best Overall Responses (iBOR). These parameters are defined as irRC criteria for immune responses, RECIST 1.1 guidelines regarding tumour size reductions or stability, and iBOR which evaluates patient's initial response until progression or death is documented.."

Answered by AI

What dangers are associated with taking the medication Nivolumab/Relatlimab?

"Despite the lack of evidence for efficacy, our team at Power assigned a rating of 2 indicating relative safety due to its Phase 2 status."

Answered by AI

What demographic is eligible to partake in this research?

"This clinical trial is enrolling 69 individuals aged 18 to 100 with melanoma who meet the following criteria: they must have signed an approved Informed Consent Form, be willing and able to comply with scheduled visits, tests and treatments; possess histologically-confirmed melanoma that is deemed inoperable according to AJCC Cancer Staging Manual (8th Edition), not having received prior anticancer treatment for metastatic disease (exceptions made); their status documented by physical examination and imaging studies within 4 weeks of first dose of study drug; disease measurable by RECIST 1.1; baseline radiographic images available before treatment initiation."

Answered by AI

Does this research study encompass individuals beyond the age of 65?

"This clinical trial only admits participants aged 18 to 100. For patients younger than 18, there are 52 separate trials while seniors over 65 have access to 742 different medical studies."

Answered by AI

Are fresh participants being accepted for this medical experiment?

"This clinical trial is no longer recruiting, with its initial posting on December 1st 2022 and subsequent update taking place on October 31st. Despite this, 754 other trials are currently searching for volunteers to aid in their research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

2022. "Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05428007.

All > Stage Iv Melanoma