Study on Relatlimab, Nivolumab, and Ipilimumab for Patients with Melanoma Brain Metastases
Sponsor: Stanford University
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT06712927
This clinical trial is testing a combination of three drugs—Relatlimab, Nivolumab, and Ipilimumab—to see if they can help treat patients with melanoma that has spread to the brain, whether they have symptoms or not.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of a combination of three drugs—Relatlimab, Nivolumab, and Ipilimumab—in treating patients with melanoma that has spread to the brain. The trial includes patients who have symptoms from their brain metastases and those who do not.
Eligibility Criteria
Inclusion Criteria
- Have melanoma that has spread to the brain, with at least one measurable brain tumor that hasn't been treated with local therapy.
- Be 18 years or older.
- Be in good overall health, with a performance status score of 0-1 for those without symptoms and 0-2 for those with symptoms.
- Have not received certain types of immunotherapy for advanced melanoma, unless it was more than 6 months ago.
- Have good organ function based on specific blood tests.
- Have recovered from any side effects of previous cancer treatments to a mild level.
- For those without symptoms: must not have needed steroids for brain symptoms recently. For those with symptoms: can be on a low dose of steroids or none at all.
- If HIV-positive, must be on effective treatment with an undetectable viral load.
- If previously infected with hepatitis B or C, must be treated and cured, or have an undetectable viral load if still on treatment.
- Provide a tumor sample for testing, if available.
- Any previous radiation or surgery to non-target brain tumors must have been done at least a week before starting the study.
- Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control during and after the study.
- Must understand the study and agree to participate by signing a consent form.
Exclusion Criteria
- Have another type of cancer within the last 3 years, except for certain treated cancers.
- Have active medical conditions that increase risk, like infections or major illnesses.
- Have an autoimmune disease needing treatment in the last 3 years.
- Have an implanted device that prevents MRI use.
- Have had severe side effects from similar treatments before.
- Have cancer spread to the brain's lining.
- Have had whole brain radiation therapy.
- Be pregnant or breastfeeding.
- Have significant heart disease or recent heart issues.
- Have high levels of certain heart-related proteins unless cleared by a cardiologist.
- Have used investigational drugs recently.
- Be on high doses of dexamethasone.
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