The study was published on researchsquare.com as a preprint and has not yet been peer reviewed.
Key Takeaway
Generally, patients with melanoma brain metastasis are excluded from clinical trials despite the fact that checkpoint inhibitors show remarkable central nervous system (CNS) efficacy.
Why This Matters
Although the CNS is one of the most common first sites of distant metastasis and systemic treatment failure, patients with brain metastases are often excluded from clinical trials. Recent advances in treatment include checkpoint inhibitors, which have shown efficacy for patients with melanoma brain metastases. Exclusion criteria should be reassessed, because without the inclusion of such patients, knowledge about whether these drugs can mitigate progression of CNS metastasis will remain limited.
Study Design
Key Results
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Of the 475 trials assessed, 268 (69.3%) excluded patients on the basis of their CNS disease status.
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Any form of CNS disease was excluded in 69 trials (17.8%), and active disease was excluded in 101 trials (26.1%).
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Even when trials accepted patients with CNS disease as participants, either with or without CNS-directed therapy, nearly all required that patients have stable or asymptomatic CNS disease.
Limitations
Disclosures
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No funding was reported.
This is a summary of a preprint research study, “Enrollment Trends Among Patients With Melanoma Brain Metastasis in Active Clinical Trials,” led by Omar Elghawy from the University of Virginia Cancer Center. The study has not been peer reviewed. The full text can be found at researchsquare.com.
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