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Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome

NCT03767439 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-18

No results posted yet for this study

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.

Conditions

  • Basal Cell Nevus Syndrome

Interventions

DRUG

Vismodegib

150 mg PO daily

DRUG

Nivolumab

480 mg IV every 4 weeks

DRUG

Ipilimumab

1 mg/kg IV every 6 weeks

Sponsors & Collaborators

Principal Investigators

  • Richard Carvajal, MD. · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2019-12-31
Completion
2020-02-29
FDA Drug
Yes

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767439 on ClinicalTrials.gov