Include Patients With Melanoma Brain Mets in Clinical Trials?

The study was published on researchsquare.com as a preprint and has not yet been peer reviewed.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

  • Researchers collected data from ClinicalTrials.gov and assessed 475 trials.

  • Inclusion of active CNS disease and exclusion of CNS disease were the coprimary endpoints.

Key Results

  • Of the 475 trials assessed, 268 (69.3%) excluded patients on the basis of their CNS disease status.

  • Any form of CNS disease was excluded in 69 trials (17.8%), and active disease was excluded in 101 trials (26.1%).

  • 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

  • Trials were not subcategorized by year of commencement, and so any temporal trends in trial design were not assessed.

Disclosures

  • 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 The study has not been peer reviewed.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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