Actively Recruiting
ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
Led by NYU Langone Health · Updated on 2026-04-21
90
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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.
- Patients must have signed informed consent according to regulatory and institutional guidelines.
- Patients must be willing and able to comply with study visits, laboratory tests, and other study requirements.
- Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by AJCC 8th edition, including mucosal melanoma with unresectable stage III or regional/distant metastatic disease.
- Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites, or melanoma of unknown primary site.
- Patient must have at least one lesion measurable by RECIST 1.1 guidelines.
- Patients must have required specimens available at baseline for Signatera ctDNA testing (archived or fresh tumor tissue and whole blood).
- Patient must be planned to start standard first-line therapy for metastatic disease.
- Patients must not have received prior anticancer treatment for metastatic disease, except certain allowed surgeries, radiotherapy, or prior adjuvant therapies completed at least 6 months before.
- Disease status must be documented by physical exam and imaging within 4 weeks before first study dose, including CT scans and brain MRI or CT if MRI is contraindicated.
- Patients must have detectable ctDNA at baseline.
- Patient must have ECOG performance status of 0-1.
- Patients with prior or concurrent nonmelanoma cancers without interfering treatments or safety concerns are eligible.
- Asymptomatic brain metastases are allowed, including patients treated with gamma knife or stereotactic body radiation therapy, with prednisone dose less than 10 mg daily.
- Baseline lab values must meet specified criteria for blood counts, liver and kidney function, and coagulation within 14 days of first treatment.
You will not qualify if you...
- Patients with carcinomatosis meningitis or history of ocular/uveal melanoma.
- Patients with a history of myocarditis.
- Patients with active autoimmune diseases requiring immunosuppression beyond 10 mg prednisone daily, except certain allowed conditions.
- Patients needing systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressants within 14 days before first treatment.
- Patients receiving other anti-tumor therapies besides standard anti-PD-1 regimens, except bisphosphonates or RANKL inhibitors for bone metastases.
- Patients with serious or uncontrolled medical disorders or active infections that increase risk or affect participation.
- Known hypersensitivity to monoclonal antibodies.
- Pregnant patients.
- Prior melanoma therapy except certain allowed surgeries, radiotherapy, or adjuvant treatments completed at least 6 months prior.
- Laboratory abnormalities including low neutrophil or white blood cell counts, low platelets, low hemoglobin, high creatinine, elevated liver enzymes, or high bilirubin beyond specified limits.
AI-Screening
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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
CONTACT
C
Cancer Trials Office
CONTACT
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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