Enrollment Trends Among Patients with Melanoma Brain Metastasis in Active Clinical Trials

Abstract

The CNS is a common site for distant metastasis and treatment failure in melanoma patients. This study aimed to evaluate the inclusion rate of patients with melanoma brain metastases (MBM) in prospective clinical trials. 69.3% of trials excluded MBM patients based on their CNS disease. In univariate analysis, trials not employing immunotherapy (p = 0.0174), inclusion of leptomeningeal disease (p < 0.0001) and non-pharmaceutical sponsor trials (p = 0.0461) were more likely to enroll patients with MBM. Thoughtful reconsideration of clinical trial designs is needed to give patients with MBMs access to promising investigational agents and improve outcomes for patients with MBM.

Keywords:

• Melanoma
• clinical trials
• inclusion criteria
• leptomeningeal disease
• brain metastasis

Acknowledgements

We thank the University of Virginia departments of internal medicine, hematology and oncology and the school of public health sciences for their assistance in the preparation of the material contained within this manuscript.

Ethics approval and consent to participate

This study is considered exempt under the guidelines of the University of Virginia Institutional Review Board.

Author contributions

VK acted as the guarantor of integrity of the entire study. VK and OE were responsible for the study’s concepts and design. OE, RP, JS and JX were responsible for the literature research that was involved in the completion of this study. OE and RP were responsible for the data collection involved in this study. OE and JX were responsible for the data analysis and statistical analysis of this study. OE, RP, JS, BH, VK were responsible in the preparation of the manuscript. OE, JX, RP, BH and VK were responsible for the editing of the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.