Study on Using ctDNA to Guide Treatment with Ipilimumab, Nivolumab, and Relatlimab for Advanced Melanoma
Sponsor: NYU Langone Health
ClinicalTrials ID:NCT07504796
This clinical trial is exploring whether measuring ctDNA can help decide the best first-line treatment for patients with advanced melanoma. The study aims to improve progression-free survival and assess response rates and side effects.
Patient Parameters
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Program Overview
The study aims to use ctDNA measurements to guide treatment choices for patients with advanced melanoma. By monitoring ctDNA levels, researchers hope to predict disease recurrence earlier and choose the most effective treatment. The goal is to improve patient outcomes by avoiding unnecessary treatments and focusing on therapies that are more likely to work based on ctDNA levels.
Description
This study is testing a new approach to treating advanced melanoma by using ctDNA levels to guide treatment decisions. Typically, the combination of ipilimumab and nivolumab is used as the first treatment for advanced melanoma. However, this study will explore whether using ctDNA levels to decide when to add ipilimumab to nivolumab and relatlimab can lead to better outcomes. Patients with stable ctDNA levels may not need immediate changes in treatment, while those with rising ctDNA levels might benefit from switching therapies sooner. The aim is to improve treatment selection, reduce unnecessary side effects, and manage costs by focusing on treatments that are more likely to be effective.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have signed a consent form approved by an ethics committee.
- Must be willing to attend scheduled visits and tests.
- Must have advanced melanoma that cannot be surgically removed.
- Melanoma must originate from skin, acral-lentiginous, or mucosal sites, or be of unknown origin.
- Must have at least one measurable tumor.
- Must provide tumor tissue or blood samples for testing.
- Must be starting standard first-line therapy for metastatic melanoma.
- Must not have received prior treatment for metastatic melanoma, except for certain surgeries or therapies completed over 6 months ago.
- Must have a complete physical exam and imaging studies before starting treatment.
- Must have detectable ctDNA at the start of the study.
- Must have a performance status of 0-1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must not have other cancers that interfere with the study.
- Asymptomatic brain metastases are allowed if treated.
- Must meet specific blood test criteria before starting treatment.
Exclusion Criteria
- Cannot have carcinomatosis meningitis or ocular melanoma.
- Cannot have a history of myocarditis.
- Cannot have active autoimmune diseases requiring high-dose steroids.
- Cannot be on high-dose steroids or other immunosuppressive medications.
- Cannot be receiving other anti-tumor therapies.
- Cannot have serious medical conditions or infections that increase study risks.
- Cannot have allergies to monoclonal antibodies.
- Cannot be pregnant.
- Cannot have received certain prior melanoma treatments unless completed over 6 months ago.
- Cannot have specific blood test abnormalities.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NYU Langone Health | 10016 | New York | New York |
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