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

NCT07504796 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

Interventions

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".

Sponsors & Collaborators

Principal Investigators

  • Janice M. Mehnert, MD · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2029-05-31
Completion
2031-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07504796 on ClinicalTrials.gov