WithdrawnPhase 2

Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome

Stopped: Loss of funding

0Started 2019-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Prior therapy with an immunological checkpoint inhibitor
✕. Prior SMO inhibitor therapy is permitted, but patients must have developed new and/or progressive lesions on or after therapy
✕. Routine use of topical (applied to \>5% of skin) or systemic therapies that might interfere with evaluation of the study medication in the prior 4 weeks
✕. Topical corticosteroids
✕. Systemic or topical retinoids e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene
✕. Topical alpha-hydroxy acids e.g., glycolic acid, lactic acid
✕. Systemic or topical 5-fluorouracil or imiquimod to skin above the knees
✕. Patients who have not recovered from adverse events (\> Grade 1) due to prior treatments

What they're measuring

Disease control rate

Timeframe: 18 months

Trial details

NCT IDNCT03767439

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

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