RecruitingPhase 2NCT07504796

ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab

A Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced Melanoma


Sponsor

NYU Langone Health

Enrollment

90 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the use of ctDNA measurements to guide first-lien therapy choice for patients with advanced or metastatic melanoma. Primary endpoints include progression-free survival. Secondary study endpoints include objective response rate and incidence and severity of immune-related adverse events.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ipilimumab, a drug called Nivolumab, and others for people with advanced melanoma and metastatic melanoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

480 mg Nivolumab every 4 weeks

DRUGRelatlimab

160 mg Relatlimab every 4 weeks

DRUGIpilimumab

50 mg (1 mg/kg) intravenously every 8 weeks

DEVICESignatera genome MRD assay

SignateraTM is a personalized, tumor-informed circulating tumor DNA (ctDNA)-based test of molecular residual disease (MRD). The Signatera Designed on Genome test is a qualitative and quantitative test that reports the presence or absence of ctDNA as "ctDNA Positive" or "ctDNA Not Detected".


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT07504796


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