{"entity":{"id":"erivance","kind":"trial","name":"ERIVANCE BCC","aka":[],"tldr":"ERIVANCE showed that a pill blocking the hedgehog pathway shrinks most advanced basal cell carcinomas that surgery and radiotherapy can no longer control, and it produced the first approved drug for this cancer.","summary":"ERIVANCE BCC was a single-arm phase 2 trial of vismodegib, the first inhibitor of the hedgehog pathway receptor smoothened, in basal cell carcinoma that was metastatic or locally advanced and inappropriate for surgery or radiotherapy. Nearly all basal cell carcinomas depend on hedgehog signalling through loss of PTCH1 or activation of SMO, which made the pathway an obvious target.\n\nBy independent review the objective response rate was 43 percent in 63 patients with locally advanced disease and 30 percent in 33 with metastatic disease (NEJM 2012); with longer follow-up investigator-assessed responses were higher and lasted about two years in locally advanced disease. Muscle spasms, hair loss, taste loss and weight loss were nearly universal and led many patients to stop.\n\nVismodegib was approved in January 2012, the first hedgehog inhibitor and the first systemic drug for basal cell carcinoma; sonidegib followed on the BOLT trial and cemiplimab was later approved for disease that has failed hedgehog inhibitors.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00833417","url":"https://clinicaltrials.gov/study/NCT00833417"},{"label":"NEJM 2012","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113713"}],"tags":[],"related":[],"cancers":["locally-advanced-bcc","basal-cell-carcinoma"],"sections":[],"technologies":["hedgehog-inhibitors"],"targets":["smoothened"],"drugs":["vismodegib"],"companies":[],"institutions":[],"pathways":["hedgehog","basal-cell-carcinoma-signalling"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00833417","phase":"2","setting":"Locally advanced or metastatic basal cell carcinoma: vismodegib 150 mg daily","sponsor":"Genentech","result":"Objective response 43% in locally advanced and 30% in metastatic basal cell carcinoma (independent review).","yearReported":2012,"enrolled":104,"outcomes":[{"endpoint":"Objective response rate (locally advanced)","primary":true,"unit":"%","arms":[{"name":"Vismodegib","n":63,"value":43}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113713"},{"endpoint":"Objective response rate (metastatic)","primary":true,"unit":"%","arms":[{"name":"Vismodegib","n":33,"value":30}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113713"}],"replication":"BOLT (sonidegib) and the STEVIE safety study found the same response rates and the same toxicity profile."},"route":"/trials/erivance/","neighbours":{"cancer":[{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"},{"id":"locally-advanced-bcc","kind":"cancer","name":"Locally advanced and metastatic basal cell carcinoma","route":"/cancers/locally-advanced-bcc/"}],"technology":[{"id":"hedgehog-inhibitors","kind":"technology","name":"Hedgehog pathway inhibitors","route":"/technologies/hedgehog-inhibitors/"}],"target":[{"id":"smoothened","kind":"target","name":"Smoothened (hedgehog pathway)","route":"/targets/smoothened/"}],"drug":[{"id":"vismodegib","kind":"drug","name":"Vismodegib","route":"/drugs/vismodegib/"}],"pathway":[{"id":"basal-cell-carcinoma-signalling","kind":"pathway","name":"Basal cell carcinoma (KEGG map)","route":"/pathways/basal-cell-carcinoma-signalling/"},{"id":"hedgehog","kind":"pathway","name":"Hedgehog signalling","route":"/pathways/hedgehog/"}]}}