NCT07504796

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study's approach seeks to rationally, rather than empirically, choose one treatment approach over another, as well as to develop methods to predict disease recurrence at earlier time points. The combination of ipilimumab and nivolumab is the standard of care for first-line treatment of advanced melanoma. This study instead seeks to pioneer treatment choice based on evidence of molecular relapse, and to determine whether this results in superior outcomes compared with the current standard of care to treat until evidence of radiologic progression. Patients with sustained "zeroconversion" may not require an immediate switch, while patients whose ctDNA levels are detectable and/or rising may benefit from an earlier therapeutic switch. The overall goal is to improve patient selection for therapy, thus sparing the therapeutic and financial toxicities from therapies that have stopped working (i.e. patients with rising ctDNA levels) or are perhaps not necessary (patients who have sustained zeroconversion).

Conditions

• Metastatic Melanoma
• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	480 mg Nivolumab every 4 weeks
DRUG	Relatlimab	160 mg Relatlimab every 4 weeks
DRUG	Ipilimumab	50 mg (1 mg/kg) intravenously every 8 weeks
DEVICE	Signatera 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".

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-05-01
• Completion: 2031-05-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study