Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome
Status:
Withdrawn
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
This is a single-arm, phase II study to assess the efficacy of combined SMO and PD-1
inhibition with Vismodegib (SMO inhibitor) and Nivolumab (anti-PD-1 antibody) in BCNS
patients (target enrollment of 22 patients), with a primary endpoint of 18-month disease
control rate. The purpose of this study is to test the hypothesis that Nivolumab and
Vismodegib will improve the percentage of BCNS patients who achieve disease control (defined
as total tumor burden <50% of baseline) at 18 months from 50% to 80%. Baseline and
on-treatment biopsies will be obtained to characterize the immune effects of combined SMO and
PD-1 inhibition.