Actively Recruiting
A Multi-center Trial Evaluating the ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab for Advanced Melanoma
Led by NYU Langone Health · Updated on 2026-04-21
90
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of circulating tumor DNA (ctDNA) measurements to guide first-line treatment choices for patients with advanced or metastatic melanoma. The study aims to improve treatment selection by identifying molecular relapse early and comparing outcomes with current standard care, which treats until radiologic progression. The primary goal is to enhance patient outcomes while minimizing unnecessary exposure to ineffective or unneeded therapies. Patients initially receive two doses of nivolumab 480 mg with relatlimab 160 mg every 28 days. Those with undetectable ctDNA continue this treatment until disease progression or death for up to two years. Patients with positive ctDNA at week 6 but no early progression are randomized to either continue nivolumab/relatlimab or add ipilimumab 1 mg/kg every 8 weeks alongside the regimen. Patients with positive ctDNA and early progression switch to the triple therapy of ipilimumab, nivolumab, and relatlimab until progression or death. Participants undergo scheduled visits, laboratory tests, imaging including CT and MRI scans, and blood sampling for ctDNA testing. Researchers monitor progression-free survival, objective response rate, and immune-related adverse events up to two years. Treatment adherence and disease status are closely evaluated to assess the impact of ctDNA-guided therapy adjustments throughout the study period.
CONDITIONS
Brief Title
ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years old or older.
- Signed informed consent obtained before any study procedures.
- Willing and able to comply with scheduled visits and tests.
- Have active advanced melanoma: unresectable stage IIIB-IV or mucosal melanoma stage III or metastatic disease.
- Melanoma must originate from cutaneous, acral-lentiginous, mucosal, or unknown primary sites.
- Have at least one measurable lesion per RECIST 1.1 guidelines.
- Provide tumor tissue or fresh tissue and blood samples for ctDNA testing.
- Planned to start standard first-line therapy for metastatic disease.
- No prior anticancer treatment for metastatic disease except specified allowable therapies.
- Disease status documented by physical exam and imaging within 4 weeks before first dose.
- Baseline radiographic images available before starting treatment.
- Detectable ctDNA at baseline confirmed by blood test.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Prior or concurrent nonmelanoma cancers allowed if not interfering with study.
- Asymptomatic brain metastases allowed with specific criteria.
- Baseline labs meet specified blood counts and organ function criteria within 14 days of treatment start.
You will not qualify if you...
- History or presence of carcinomatosis meningitis or ocular/uveal melanoma.
- History of myocarditis.
- Active autoimmune disease requiring immunosuppression over 10 mg prednisone daily.
- Systemic corticosteroid or immunosuppressive treatment within 14 days before treatment.
- Receiving concurrent anti-tumor therapies beyond standard PD-1 regimens.
- Serious or uncontrolled medical disorders or active infections affecting safety.
- Known allergy to monoclonal antibodies.
- Pregnancy.
- Prior melanoma therapy except surgery, specified radiation, or adjuvant therapy completed over 6 months prior.
- Laboratory abnormalities including low neutrophils, platelets, hemoglobin, or elevated creatinine, liver enzymes, or bilirubin beyond set limits.
- Use of hematologic growth factors not allowed during screening or first treatment cycle.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive nivolumab and relatlimab every 4 weeks. Based on ctDNA levels at week 6, some participants may also receive ipilimumab every 8 weeks in addition to continuing nivolumab and relatlimab. Treatment continues until radiologic progression or death for up to 2 years.
Doses of nivolumab and relatlimab every 4 weeks; ipilimumab every 8 weeks for some participants
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
J
Janice M. Mehnert, MD
C
Cancer Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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