RecruitingPhase 2NCT03563729

Melanoma Metastasized to the Brain and Steroids

Efficacy of Immunotherapy in Melanoma Patients With Brain Metastases Treated With Steroids


Sponsor

Inge Marie Svane

Enrollment

80 participants

Start Date

Jun 6, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether using steroid medications (like prednisone or dexamethasone) to manage brain swelling in patients with melanoma that has spread to the brain affects how well immunotherapy and other cancer treatments work. **You may be eligible if...** - You have been diagnosed with melanoma (a type of skin cancer) that has spread to the brain, confirmed by imaging scans - You need steroid treatment to manage brain swelling (for example, prednisone more than 10 mg/day or dexamethasone more than 1.6 mg/day) - You have at least one measurable area of cancer - You are 18 years or older and in reasonable physical condition - You are able to have an MRI with contrast dye **You may NOT be eligible if...** - You are pregnant or unable to use effective contraception - Your organ function does not meet the required levels - You had significant side effects from previous cancer treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab Injection [Keytruda]

Alone

DRUGIpilimumab Injection [Yervoy]

In combination with nivolumab.

DRUGNivolumab Injection [Opdivo]

In combination with ipilimumab.

DRUGEncorafenib

In combination with binimetinib

DRUGBinimetinib

In combination with encorafenib

DRUGDabrafenib

In combination with dabrafenib

DRUGTrametinib

In combination with trametinib


Locations(3)

Herlev Universityhospital

Herlev, Capital Region, Denmark

Aarhus Universityhospital

Aarhus, Midt, Denmark

Odense Universityhospital

Odense, Syd, Denmark

View Full Details on ClinicalTrials.gov

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NCT03563729


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