Clinical trial · Interventional
A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma
A Pilot Study to Evaluate Short Term Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinomas in Cosmetically Challenging Locations
NCT03534947CI-TRIAL-00099056SONIBcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, patients with BCC will be given neoadjuvant treatment with a drug called sonidegib. Sonidegib is a daily tablet usually given for BCC that cannot be removed by surgery or that has spread through the body. The study aims to see if sonidegib given for 12 weeks will reduce the size of tumours so surgery results in less scarring or may be avoided, with only short term topical treatment required to treat remaining tumour.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Basal Cell Carcinoma of Skin, Site Unspecified | Skin Basal Cell Carcinoma | ALIAS | 0.85 |
| Invasive Carcinoma | Invasive Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Sonidegib followed by imiquimod
- description
- Sonidegib 200mg taken orally once a day for 12 weeks. COMPLETE OR PARTIAL RESPONSE WITH SUPERFICAL REMNANT LESION For patients with a complete response or a partial response resulting in a superficial lesion, treatment with topical imiquimod for 5 days a week for 6 weeks will be prescribed.
- interventionNames
- Drug: Sonidegib
- Drug: Imiquimod
- type
- EXPERIMENTAL
- label
- Sonidegib followed by surgery
- description
- Sonidegib 200mg taken orally once a day for 12 weeks. PARTIAL RESPONSE WITH REMNANT INVASIVE LESION For patients with a no change on BCC size / depth or patients with a partial response but a remaining invasive lesion, will have surgical excscion of the remaining lesion.
- interventionNames
- Drug: Sonidegib
- Procedure: Surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age. * Written informed consent. * Histologically confirmed, resectable, invasive basal cell carcinoma. * Site and size of BCC considered to be in a cosmetically challenging position for surgery. * Patient has expressed concerns of the cosmetic outcome of surgery. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Ability to swallow and retain oral medication. * Anticipated life expectancy of \> 12 months. * Adequate organ function as demonstrated by blood tests. * Willing to abstain from blood donations for 20 months from the last dose of sonidegib. * Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 6 months after the last dose. * Female patients with active contraception or no menstrual cycle for \>12 months Exclusion Criteria: * Inoperable basal cell carcinoma tumours. * A concurrent cancer diagnosis requiring any systemic anti-cancer therapy. * Serious or unstable pre-existing medical conditions or other conditions or laboratory abnormalities that could interfere with the patient's safety, consent, or compliance. * History of malabsorption or other conditions that would interfere with the absorption of sonidegib. * Known psychiatric or substance abuse disorders that would interfere with cooperation and compliance with the requirements of the trial. * Prior treatment with hedgehog pathway inhibitors. * Concomitant medications that may result in increased or decreased bioavailability of sonidegib. * Patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, rhabdomyolysis, amyotrophic lateral sclerosis and spinal muscular atrophy) due to an increased risk of muscle toxicity with sonidegib. * Male patients expecting to father children or donate sperm during the 12 weeks of sonidegib treatment and for a further 6 months from the end of treatment. * Pregnant or breastfeeding women
References
Publications (4)
- BACKGROUNDChang AL, Atwood SX, Tartar DM, Oro AE. Surgical excision after neoadjuvant therapy with vismodegib for a locally advanced basal cell carcinoma and resistant basal carcinomas in Gorlin syndrome. JAMA Dermatol. 2013 May;149(5):639-41. doi: 10.1001/jamadermatol.2013.30. No abstract available. PMID 23677114
- BACKGROUNDCheng HM, Guitera P. Systematic review of optical coherence tomography usage in the diagnosis and management of basal cell carcinoma. Br J Dermatol. 2015 Dec;173(6):1371-80. doi: 10.1111/bjd.14042. Epub 2015 Oct 27. PMID 26211438
- BACKGROUNDCheng HM, Lo S, Scolyer R, Meekings A, Carlos G, Guitera P. Accuracy of optical coherence tomography for the diagnosis of superficial basal cell carcinoma: a prospective, consecutive, cohort study of 168 cases. Br J Dermatol. 2016 Dec;175(6):1290-1300. doi: 10.1111/bjd.14714. Epub 2016 Sep 24. PMID 27146027
- BACKGROUNDChing JA, Curtis HL, Braue JA, Kudchadkar RR, Mendoza TI, Messina JL, Cruse CW, Smith DJ Jr, Harrington MA. The impact of neoadjuvant hedgehog inhibitor therapy on the surgical treatment of extensive basal cell carcinoma. Ann Plast Surg. 2015 Jun;74 Suppl 4:S193-7. doi: 10.1097/SAP.0000000000000452. PMID 25695449