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ctDNA-guided Treatment for Metastatic Melanoma

This study is looking at a new way to decide treatment for advanced or metastatic melanoma. It uses a personalized blood test called Signatera (a ctDNA test) to measure circulating tumor DNA (ctDNA) — tiny pieces of tumor DNA in your blood. The study aims to see if using this test to guide when to add the drug Ipilimumab to a combination of Nivolumab and Relatlimab can improve how long patients live without their cancer growing. You might be able to join if you are at least 18 years old and have advanced or metastatic melanoma. The study is currently unclear about its recruitment status.

Study design
This is an interventional study planning to enroll 90 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Progression Free Survival, is measured at Month 6. Other follow-up details are not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07504796

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
NYU Langone Health
~90 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:NivolumabRelatlimabIpilimumabSignatera genome MRD assay

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival rate in patients randomized in Cohort B
Measured over Month 6

Conditions

Metastatic Melanoma
Advanced Melanoma

Explore related trials

MelanomaCirculating Tumor-Derived DNA Negative

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Janice M. Mehnert, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Janice M. Mehnert, MD
[email protected]
212-731-5431
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

white blood cells (WBCs) ≥ 2000/μL
Neutrophils ≥ 1500/μL
Platelets ≥ 100 × 10³/μL
Hemoglobin ≥ 9.0 g/dL
Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance \> 40 mL/minute (using Cockcroft/Gault formula)
Aspartate Aminotransferase (AST) ≤ 1.5 × ULN
Alanine Aminotransferase (ALT) ≤ 1.5 × ULN
Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert Syndrome who must have total bilirubin \< 3.0 mg/dL)
Coagulation : Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR)

Exclusion

Absolute Neutrophil Count (ANC) \< 1,500/μL or WBC \< 2,000 μL
Platelet count \< 100,000/μL
Hematologic growth factors are not allowed at screening or during the first cycle of treatment
Hemoglobin \< 9 g/dL (\< 5.5 mmol/L; previous red blood cell (RBC) transfusion is permitted)
Creatinine \> 1.5 × ULN
AST or ALT \> 1.5 × ULN. For patients with liver metastasis AST or ALT \> 3 × ULN
Serum total bilirubin \> 1.5 mg/dL or \> 3 × ULN for patients with hereditary benign hyperbilirubinemia

What this trial measures

  • Progression Free Survival rate in patients randomized in Cohort BMonth 6

    Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 (with irRECIST used as a supportive criterion) or death from any cause, whichever occurs earlier.