# VISMONEO (vismodegib before surgery for locally advanced basal cell carcinoma)

Source: https://onco.cc/trials/vismoneo/  
OnCo record `vismoneo` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Giving the hedgehog pill first to shrink a large facial basal cell carcinoma made the operation smaller or less disfiguring in four out of five people. Over three years, though, more than a third of those who benefited had the cancer back.

## Summary

The argument for a drug in basal cell carcinoma is usually about inoperable disease. VISMONEO asked a different and more common question: can the drug make an operable but disfiguring operation into a smaller one? Fifty-five patients with a facial basal cell carcinoma, median age 73 and mean target lesion size 47.3 mm, were given vismodegib 150 mg daily for four to ten months and then operated on once the best response had been reached. Four were inoperable at entry, fifteen operable with a major functional risk and 36 operable with a minor functional risk or a major risk to appearance.

Forty-four patients (80 per cent, 95 per cent confidence interval 67 to 90) were downstaged on the six-stage surgical classification, which was the primary endpoint. Of those 44, 27 had a complete response, 25 of them proved on biopsy. The objective response rate by the standard tumour response criteria was 71 per cent (59 to 88) and the mean treatment duration was 6.0 months.

The three-year follow-up is the part that is usually left out of the summary and should not be: 16 of the 44 downstaged patients had a known recurrence, 36 per cent (22 to 51). A neoadjuvant hedgehog inhibitor changes the operation. It does not remove the need for one, and it does not make the disease go away.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: VISMONEO
- Registry id: NCT02667574
- Phase: 2
- Setting: At least one histologically confirmed facial basal cell carcinoma, inoperable or operable only with a risk of functional loss or major disfigurement: oral vismodegib 150 mg daily for four to ten months before planned surgery, with the proportion of patients whose surgery was downstaged on a six-stage surgical classification as the primary endpoint
- Sponsor: University Hospital, Lille, funded by F. Hoffmann-La Roche
- Enrolled: 55
- Result: Surgical downstaging in 44 of 55 patients (80 per cent, 95 per cent confidence interval 67 to 90) with 27 complete responses, an objective response rate of 71 per cent, and recurrence in 16 of the 44 downstaged patients (36 per cent) by three years.
- Outcomes: Surgical downstaging after neoadjuvant vismodegib: Vismodegib 150 mg daily before surgery 80%; Objective response rate: Vismodegib 150 mg daily before surgery 71%; Recurrence at 3 years among downstaged patients: Vismodegib 150 mg daily before surgery 36%
- Replication: Small periocular series have reported the same direction with mixed histological response: in one series of eight patients only two had complete histological regression, and two showed squamous differentiation after treatment.

## Sources

- ClinicalTrials.gov NCT02667574: https://clinicaltrials.gov/study/NCT02667574
- First results (EClinicalMedicine 2021): https://doi.org/10.1016/j.eclinm.2021.100844
- First results on PubMed: https://pubmed.ncbi.nlm.nih.gov/33997740/

## Connected records

- cancers: [Basal cell carcinoma](https://onco.cc/cancers/basal-cell-carcinoma/), [Locally advanced and metastatic basal cell carcinoma](https://onco.cc/cancers/locally-advanced-bcc/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/)
- technologies: [Hedgehog pathway inhibitors](https://onco.cc/technologies/hedgehog-inhibitors/)
- targets: [Smoothened (hedgehog pathway)](https://onco.cc/targets/smoothened/)
- drugs: [Vismodegib](https://onco.cc/drugs/vismodegib/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- pathways: [Hedgehog signalling](https://onco.cc/pathways/hedgehog/)
- terms: [Mohs surgery](https://onco.cc/terms/mohs-surgery/), [Why people stop taking hedgehog inhibitors](https://onco.cc/terms/hedgehog-inhibitor-tolerability/)
- trials: [Cemiplimab in basal cell carcinoma after a hedgehog inhibitor](https://onco.cc/trials/cemiplimab-advanced-bcc/), [ERIVANCE BCC](https://onco.cc/trials/erivance/), [STEVIE (vismodegib in ordinary practice)](https://onco.cc/trials/stevie/)

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