Basal Cell CarcinomaPhase 2SONIBNCT03534947

A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma

A Phase 2 study testing Sonidegib, Imiquimod and Surgery in people with Basal Cell Carcinoma and Basal Cell Carcinoma of Skin, Site Unspecified, run by Melanoma Institute Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Basal Cell Carcinoma, Basal Cell Carcinoma of Skin, Site Unspecified, Skin Cancer
What is being tested?: Sonidegib, Imiquimod and Surgery
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteAustralia
Study dates: 23 Jul 2019to 1 Mar 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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.

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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

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

Australia1 site

Melanoma Institute Australia
North Sydney, New South Wales, 2060

Other trials in Australia

About this study

Official title: 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

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.

Read the detailed description

Surgery is the first line treatment for most basal cell carcinomas (BCCs) with cure rates of 88 to 96%. However, excision of large lesions in sensitive locations such as the face and scalp may result in disfigurement and impairment of function. Neoadjuvant drug treatment given before surgery aims to reduce tumour size so that surgery and recovery is easier. 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. This approach may also reduce the risk of recurrence. To assess response to treatment, we will use a new technology for skin tumours called optical coherence technology (OCT). This is like an ultrasound scan and is non invasive. OCT can detect the extent and nature of the tumour and build a 3D image with great accuracy. OCT will be used together with pathological analysis of tumour tissue to determine response to sonidegib.

Conditions: Basal Cell Carcinoma, Basal Cell Carcinoma of Skin, Site Unspecified, Skin Cancer, Invasive Carcinoma
Being tested: Sonidegib, Imiquimod, Surgery, Best supportive care
Keywords: Neoadjuvant, Sonidegib
Medical subject headings: Carcinoma, Basal Cell, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SonidegibDrug
Also called LDE225, Odomzo
Sonidegib is a selective and orally bioavailable Smoothened (Smo) antagonist. The dose will be 200mg taken once a day for 12 weeks.
ImiquimodDrug
Also called Aldara
Imiquimod is an immune response modifier that promotes NF-kappa-B-mediated secretion of pro-inflammatory cytokines, chemokines and other mediators. These immune responses produce cytotoxic effects that are antiproliferative and anti-tumour. Imiquimod treatment requires an extended treatment period of 6 weeks for superficial BCC. Imiquimod is an option for the treatment of small, low-risk superficial BCC when surgery, curettage or cryotherapy are inappropriate. Treatment with imiquimod will be for 5 days a week for a total of 6 weeks.
SurgeryProcedure or surgery
Also called Excision of remnant invasive basal cell carcinoma
Although most BCCs are amenable to surgery, excision of large tumours in aesthetically sensitive sites may compromise function or cosmesis. Patients whose BCC has not shrunk in size or depth following 12 weeks of sonidegib will undergo surgical excision of the remaining tumour.
Best supportive careOther
Patients with lesions that have progressed in size and/or depth will receive the best supportive care deemed appropriate by the treating clinician. This may be surgery, imiquimod, a clinical trial treatment, radiotherapy or any combination of these interventions

Study groups in NCT03534947
Study group	Role	What they receive
Sonidegib followed by imiquimod	Experimental	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. Receives: Drug: Sonidegib; Drug: Imiquimod
Sonidegib followed by surgery	Experimental	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. Receives: Drug: Sonidegib; Procedure: Surgery
Sonidegib then best supportive care	Other	Sonidegib 200mg taken orally once a day for 12 weeks. PROGRESSIVE DISEASE Patients with lesions that have progressed in size and/or depth will receive the best supportive care deemed appropriate by the treating clinician. This may be surgery, imiquimod, a clinical trial treatment, radiotherapy or any combination of these interventions. Receives: Drug: Sonidegib; Other: Best supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

Neoadjuvant treatment response determined by optical coherence tomography
The size and spread of abnormal skin structures associated with basal cell carcinoma detected by optical coherence tomography.
Measured: 12 weeks

Secondary outcomes (11)

Neoadjuvant treatment response determined by histopathology
The size and spread of basal cell carcinoma tumour in a biopsy taken from the known worse affected area of disease demonstrated by histopathologic analysis.
Measured: 12 weeks
Histologic response to neoadjuvant treatment in basal cell carcinoma sub types
The amount and spread of basal cell carcinoma tumour cells and structures detected at histopathology analysis in nodular and in infiltrative sub types of BCC.
Measured: 12 weeks
Response to neoadjuvant treatment in basal cell carcinoma sub types measured with optical coherence tomography.
The amount and spread of basal cell carcinoma tumour cells and structures detected at histopathology analysis in nodular and in infiltrative sub types of BCC.
Measured: 12 weeks
Recurrence rate
The number of patients who have a recurrence of basal cell carcinoma at the original site of disease after having surgery or 6 weeks of topical treatment with imiquimod.
Measured: 6 and 12 months after surgery or at the end of 6 weeks of treatment with imiquimiod.
Drug related adverse reactions
The proportion of patients experiencing any adverse drug reactions graded according to CTCAE version 4.
Measured: 12 weeks
Discontinuation of sonidegib due to adverse reactions
The proportion of patients who discontinue sonideigb because of adverse drug reactions.
Measured: 12 weeks
Quality of life based on SKINDEX-16
The scores obtained from the validated SKINDEX-16 quality of life questionnaire compared to baseline.
Measured: Weeks 12 and 18 and months 6 and 12.
Patient rated cosmetic outcome after neoadjuvant treatment followed by surgery
Scores from a 3 likert scale questions assessing the patient's agreement with statements about the appearance of their surgical scar for patients who need surgery after neoadjuvant treatment.
Measured: Week 12
Surgeon rated cosmetic outcome after neoadjuvant treatment followed by surgery
Scores from a 3 likert scale questions assessing the surgeon's agreement with statements about the appearance of their surgical scar for patients who need surgery after neoadjuvant treatment.
Measured: Week 12
Patient rated cosmetic outcome after neoadjuvant treatment
Scores from a 3 likert scale questions assessing the patient's agreement with statements about the appearance of the remmant BCC area for patients who did not need surgery after neoadjuvant treatment.
Measured: Week 12
Surgeon rated cosmetic outcome after neoadjuvant treatment
Scores from a 3 likert scale questions assessing the surgeons's agreement with statements about the appearance of the remmant BCC area for patients who did not need surgery after neoadjuvant treatment.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 20191 Mar 2025

First posted23 May 2018
Study start23 Jul 2019
Primary completion1 Mar 2025
Study completion1 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This is a pilot study which will evaluate the efficacy and safety of short term neoadjuvant sonidegib followed by surgery or imiquimod in the management of basal cell carcinomas in cosmetically challenging locations, assessed by optical coherence tomography and histopathology. The data from this pilot study may lead to the design of larger scale trials of neoadjuvant targeted therapy with the aim to decrease the morbidity of surgical treatment and increase the probability of a curative resection in larger patient populations.
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03534947
Sponsor's protocol ID: MIA2017/CT/220
Other IDs: HREC file number 18/087
Acronym: SONIB
Status last verified: Dec 2025
First submitted: 1 May 2018
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Chang 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.
PubMed 23677114
Cheng 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.
PubMed 26211438
Cheng 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.
PubMed 27146027
Ching 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.
PubMed 25695449

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03534947
Acronym / sponsor ID: SONIB / MIA2017/CT/220
Conditions: Basal Cell Carcinoma, Basal Cell Carcinoma of Skin, Site Unspecified, Skin Cancer, Invasive Carcinoma
Keywords: Neoadjuvant, Sonidegib
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Melanoma Institute AustraliaUniversity, hospital or other
Study start: 23 Jul 2019 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 23 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This is a pilot study which will evaluate the efficacy and safety of short term neoadjuvant sonidegib followed by surgery or imiquimod in the management of basal cell carcinomas in cosmetically challenging locations, assessed by optical coherence tomography and histopathology. The data from this pilot study may lead to the design of larger scale trials of neoadjuvant targeted therapy with the aim to decrease the morbidity of surgical treatment and increase the probability of a curative resection in larger patient populations.

Arm	Type	Receives
Sonidegib followed by imiquimod	Experimental	Drug: Sonidegib, Drug: ImiquimodSonidegib 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.
Sonidegib followed by surgery	Experimental	Drug: Sonidegib, Procedure: SurgerySonidegib 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.
Sonidegib then best supportive care	Other	Drug: Sonidegib, Other: Best supportive careSonidegib 200mg taken orally once a day for 12 weeks. PROGRESSIVE DISEASE Patients with lesions that have progressed in size and/or depth will receive the best supportive care deemed appropriate by the treating clinician. This may be surgery, imiquimod, a clinical trial treatment, radiotherapy or any combination of these interventions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

≥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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SonidegibAlso: LDE225, OdomzoSonidegib is a selective and orally bioavailable Smoothened (Smo) antagonist. The dose will be 200mg taken once a day for 12 weeks.	Drug	Sonidegib followed by imiquimod, Sonidegib followed by surgery, Sonidegib then best supportive care
ImiquimodAlso: AldaraImiquimod is an immune response modifier that promotes NF-kappa-B-mediated secretion of pro-inflammatory cytokines, chemokines and other mediators. These immune responses produce cytotoxic effects that are antiproliferative and anti-tumour. Imiquimod treatment requires an extended treatment period of 6 weeks for superficial BCC. Imiquimod is an option for the treatment of small, low-risk superficial BCC when surgery, curettage or cryotherapy are inappropriate. Treatment with imiquimod will be for 5 days a week for a total of 6 weeks.	Drug	Sonidegib followed by imiquimod
SurgeryAlso: Excision of remnant invasive basal cell carcinomaAlthough most BCCs are amenable to surgery, excision of large tumours in aesthetically sensitive sites may compromise function or cosmesis. Patients whose BCC has not shrunk in size or depth following 12 weeks of sonidegib will undergo surgical excision of the remaining tumour.	Procedure or surgery	Sonidegib followed by surgery
Best supportive carePatients with lesions that have progressed in size and/or depth will receive the best supportive care deemed appropriate by the treating clinician. This may be surgery, imiquimod, a clinical trial treatment, radiotherapy or any combination of these interventions	Other	Sonidegib then best supportive care

Primary outcome

Neoadjuvant treatment response determined by optical coherence tomography
Time frame: 12 weeks
The size and spread of abnormal skin structures associated with basal cell carcinoma detected by optical coherence tomography.

11 secondary outcomes

Neoadjuvant treatment response determined by histopathology
Time frame: 12 weeks
Histologic response to neoadjuvant treatment in basal cell carcinoma sub types
Time frame: 12 weeks
Response to neoadjuvant treatment in basal cell carcinoma sub types measured with optical coherence tomography.
Time frame: 12 weeks
Recurrence rate
Time frame: 6 and 12 months after surgery or at the end of 6 weeks of treatment with imiquimiod.
Drug related adverse reactions
Time frame: 12 weeks
Discontinuation of sonidegib due to adverse reactions
Time frame: 12 weeks
Quality of life based on SKINDEX-16
Time frame: Weeks 12 and 18 and months 6 and 12.
Patient rated cosmetic outcome after neoadjuvant treatment followed by surgery
Time frame: Week 12
Surgeon rated cosmetic outcome after neoadjuvant treatment followed by surgery
Time frame: Week 12
Patient rated cosmetic outcome after neoadjuvant treatment
Time frame: Week 12
Surgeon rated cosmetic outcome after neoadjuvant treatment
Time frame: Week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Background: PubMed 23677114Chang 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.
Background: PubMed 26211438Cheng 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.
Background: PubMed 27146027Cheng 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.
Background: PubMed 25695449Ching 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pascale Guitera, MD PhD study director

Melanoma Institute Australia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neoadjuvant treatment response determined by optical coherence tomography (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03534947, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.