The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.
The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry
* Organ transplant patients who have had at least one biopsy-positive SCC
* Aged 18 - 75 years
* Written informed consent to the performance of all study-specific procedures
Exclusion Criteria:
* Allergy to afamelanotide (CUV1647) or the polymer contained in the implant
* History of melanoma
* Current pigmentary disorders such as melasma
* Diagnosed with HIV/AIDS, or hepatitis B or C
* Current history of drug or alcohol abuse (in the last 12 months)
* Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures
* Major medical or psychiatric illness
* Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers
* Females of child bearing potential not using adequate contraceptive measures
* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit
* Use of regular medications or any other factors that may affect skin pigmentation
Discontinuation Criteria:
* Initiation of treatment with systemic retinoids
* Change of class of systemic immunosuppressant treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands