Using topical sirolimus to prevent skin cancer in organ transplant recipients

A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients

This study is testing if a cream containing sirolimus can help prevent skin cancer in people who have received organ transplants.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Melanoma and Skin Cancer Trials Limited (Academic / other)
• Locations: 6 sites (Camperdown, New South Wales and 5 other locations)
• Trial ID: NCT05860881 on ClinicalTrials.gov

What this trial studies

This phase 3, double-blind, multi-centre trial evaluates the effectiveness of topical 1% sirolimus in preventing skin cancer among solid organ transplant recipients. Participants will apply the cream nightly for 24 weeks, with the aim of reducing the incidence of new skin cancers compared to a placebo group. The study builds on previous findings that suggest topical sirolimus is safe and effective in reducing early signs of skin cancer. By addressing the high burden of skin cancer in this population, the trial seeks to improve patient outcomes and reduce the need for surgical interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have received an organ transplant at least 12 months prior and have a history of skin cancer.

Not a fit: Patients currently receiving oral sirolimus or everolimus, or those with facial skin cancers requiring surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of skin cancer in solid organ transplant recipients, improving their quality of life.

How similar studies have performed: Previous studies have shown promise with topical sirolimus in reducing skin cancer burden, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Be aged 18 years or older and able to provide consent
2. Have received an organ transplant equal to or greater than 12 months prior to consent
3. Have had at least 1 SCC/BCC in the past 5 years
4. Have at least 5 keratotic lesions on their face at inclusion

Exclusion Criteria:

1. Are currently receiving sirolimus or everolimus orally\*
2. Have a skin cancer on their face requiring excisional surgery\*\*
3. Have an open wound on their face requiring treatment
4. Are pregnant or planning to become pregnant in the next 6 months
5. Anticipate elective medical events which may prevent daily cream application.
6. Are unable to provide informed consent, complete questionnaires and attend trial site for visits
7. Are participating in another clinical trial with an investigational drug/device aiming to reduce skin cancers or affect level of immunosuppression
8. Planning to move overseas within 2 years

(\*)Patients are eligible to join the study after ceasing treatment and after a washout period of 16 days for sirolimus and 8 days for everolimus.

(\*\*) Once treatment of the lesion is completed these patients can be re-screened.

Where this trial is running

Camperdown, New South Wales and 5 other locations

• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
• Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
• The Prince Charles Hospital — Chermside, Queensland, Australia (Recruiting)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
• Skin Health Institute — Carlton, Victoria, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Melanoma and Skin Cancer Trials Coordinator

Conditions Solid Organ Transplant Recipients; Skin Cancer