The enrollment status of patients with brain metastases in metastatic renal cell carcinoma: A query of clinicaltrials.gov.

e16070 Background: Clinical trials routinely exclude patients with brain metastases in metastatic renal cell carcinoma (mRCC). However, the degree to which such patients are excluded has not been documented. Routine exclusion of such patients limits applicability of trial results and obfuscates potential benefit in this subpopulation. This study aims to systematically determine the status of central nervous system (CNS) disease exclusion, with or without leptomeningeal disease, in clinical trial enrollment in interventional studies of mRCC. Methods: ClinicalTrials.gov was systematically queried to characterize the CNS exclusion criteria among open, interventional trials in mRCC. Results: Of 121 open trials, 29 (24%) strictly excluded patients with CNS metastasis. 69 trials (57%) enrolled patients with CNS metastasis with contingencies (i.e. prior CNS-directed local therapy, and/or lack of neurologic symptoms). Two trials (2%) enrolled patients with CNS metastasis without exception. 21 trials (17%) did not specify enrollment criteria with respect to CNS disease. In multivariate analysis of the effect of trial phase, location, sponsor, treatment type, and histologic subtype on CNS exclusion criteria, only location had a statistically significant effect. Trials performed exclusively within the United States had higher odds of excluding patients with CNS metastases than global trials (OR = 8.889, 95% CI: 1.405-56.251, p = 0.023) or trials performed exclusively outside of the United States (OR = 2.778, 95% CI: 1.054-1.758, p = 0.053). Conclusions: Due to the high rate of exclusion of patients with brain metastases in mRCC, many trial results cannot be reliably generalized to this subpopulation. Consideration should be given to looking at the effect of new systemic therapies on patients with CNS metastases to clarify benefit or harm in this subpopulation.