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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07504796
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    480 mg Nivolumab every 4 weeks
  • Relatlimab — DRUG
    160 mg Relatlimab every 4 weeks
  • Ipilimumab — DRUG
    50 mg (1 mg/kg) intravenously every 8 weeks
  • Signatera genome MRD assay — DEVICE
    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".

Study Details

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.

Key Dates

Start date
Apr 13, 2026
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
May 31, 2031

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Undetectable ctDNA
    Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients with undetectable ctDNA ("zeroconversion") will continue on this regimen until radiologic progression or death for up to 2 years, per standard of care.
  • Active Comparator: Cohort B: Positive ctDNA without early progresson (continue treatment)
    Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients who exhibit positive ctDNA at week 6, who do not exhibit "zeroconverson" at week 6 will be randomized to one of two treatment arms in Cohort B. In this arm patients continue treatment with 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4 week intervals.
  • Experimental: Cohort B: Positive ctDNA without early progression (switch treatment)
    Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients who exhibit positive ctDNA at week 6, who do not exhibit "zeroconverson" at week 6 will be randomized to one of two treatment arms in Cohort B. In this arm patients receive 1 dose of ipilimumab at 1 mg/kg in 8 week intervals in addition to 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4 week intervals.
  • Experimental: Cohort C: Positive ctDNA with early progression
    Patients will be treated with 2 doses of nivolumab 480 mg/relatlimab 160 mg given every 28 days. Patients with positive ctDNA and progressive disease (early progression) on scans at week 6 will switch to ipilimumab at 1 mg/kg in 8-week intervals in addition to 2 doses of nivolumab 480 mg/relatlimab 160 mg at 4-week intervals. Cohort C patients will continue on this regimen until radiologic progression or death for up to 2 years, per standard of care.

Primary Outcome Measure

Progression Free Survival rate in patients randomized in Cohort B [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
NYU Langone Health· New York, NY

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