A Phase 3 interventional study of Melatonin in Uveal Melanoma, Uveal Melanoma, Posterior, Medium/Large Size and Eye Cancer, Intraocular Melanoma, sponsored by Gustav Stalhammar. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Gustav Stalhammar · Phase 3, Interventional, and Prevention
Uveal melanoma (UM) is the most common type of cancer inside the eyes of adults. Almost half of all patients diagnosed with UM will eventually develop metastases. Once metastases occur, the median patient survival is short.
In this trial, we will test if treatment with Melatonin after primary tumor diagnosis can prevent or delay the development of metastases. 100 patients diagnosed with primary UM will be randomized to either treatment with Melatonin tablets (20 mg at night), or to a control group. Both groups will be followed for 5 years. At 5 years, the number of patients that have developed metastases in the Melatonin and control groups will be compared (primary outcome measure).
At the time of primary UM diagnosis, about 2 % of patients have radiologically detectable metastases. Within 15 years, this proportion increases to 32-45 % even with successful treatment of the eye. Presumably, this is caused by subclinical dormant micrometastases that most frequently locate to the liver. Once these leave their dormant state and grow into clinically detectable lesions, few effective treatment alternatives are available and the median patient survival is about one year.
Several trials have tested interventions for metastatic UM, and in comparison with the greatly improved results for cutaneous melanoma during the last decades, response rates and durations have been low.
The AMUM trial will therefore test if adjuvant treatment with Melatonin for 5 years after primary tumor diagnosis can prevent or delay the onset of metastases. 100 patients recently diagnosed with primary UM and found to have a high risk of metastasis will be recruited. The trial is administered from St. Erik Eye Hospital, Stockholm, Sweden, who has a national responsibility for the diagnosis, plaque brachytherapy treatment and histopathological examination of uveal melanomas. This means that all Swedish patients that are diagnosed with uveal melanoma may be considered for inclusion in the trial, regardless of their region of residence. Patients will be screened for eligibility, informed, recruited, randomized, and treated from St. Erik Eye Hospital. Follow-up will be conducted in cooperation with multiple centers all over the country.
When informed consent has been obtained, the 100 patients will then be randomized to either treatment with oral tablets of Melatonin (20 mg, taken before bedtime) for 5 years, or to a control group. Both groups will be followed with regular contacts from the investigators, with radiological examinations of the liver every 6 months, and with a blood test at the time of recruitment and then year 2 and 4.
When the last patient has taken his or her last tablet after 5 years of treatment, we will examine the primary outcome measure (relative risk of metastasis) and secondary outcome measures (overall survival, survival after development of metastases, number of patients developing other cancers, adverse events (AE) and serious adverse events (SAE)) in the Melatonin vs. control arm.
AMUM is an Investigator-Initiated Trial without commercial interests.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →This is the only study on the registry with Gustav Stalhammar as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The patient has a melanoma originating in the choroid or in the ciliary body, as diagnosed by clinical methods and/or histological examination.
AND at least one of the following 7 items:
Exclusion Criteria:
Melatonin tablet 5 mg. 4 tablets taken at night (20 mg) for 5 years.
Drug: Melatonin
No intervention. Follows the current standard of observation after primary tumor treatment.
White round tablets, each with a dose of 5 mg Melatonin. 4 tablets taken simultaneously at night. Tablets can be crushed and/or taken with a glass of water if the patient wish.
Also known as: Melatonin AGB Pharma
Number of patients that develop metastases in Melatonin vs. Control arm, evaluated as relative risk (RR).
Measured as relative risk (i.e., the incidence rate of metastasis in the Melatonin arm divided by the incidence rate in the control group), with 95 % confidence interval.
Time frame: 5 years
Number of patients that develop metastases in Melatonin vs. Control arm, evaluated as Cox regression hazard ratio (HR).
Measured as hazard ratio (i.e., the hazard for metastasis in the Melatonin arm divided by the hazard in the control group) with relevant covariates (e.g., tumor size, patient age, BAP-1 expression), with 95 % confidence interval.
Time frame: 5 years
Overall survival (OS) time from randomization in Melatonin vs. Control arm, evaluated with the Log-rank test.
Overall survival (the length of time from randomization that patients are still alive) in the Melatonin vs. Control arm. A Kaplan-Meier-curve will be drawn and the Log-rank test will be applied.
Time frame: 5 years
Overall survival (OS) time from the detection of metastasis in Melatonin vs. Control arm, evaluated with the Log-rank test.
Overall survival (the length of time from radiological detection of metastases that patients are still alive) in the Melatonin vs. Control arm. A Kaplan-Meier-curve will be drawn and the Log-rank test will be applied.
Time frame: 5 years
Number of patients that develop other cancers (i.e., cancer diagnoses other than uveal melanoma) in Melatonin vs. Control arm, evaluated as relative risk (RR).
Measured as relative risk (i.e., the incidence rate of other cancers in the Melatonin arm divided by the incidence rate in the control group), with a 95 % confidence interval.
Time frame: 5 years
Number of patients that develop other cancers (i.e., cancer diagnoses other than uveal melanoma) in Melatonin vs. Control arm, evaluated as Cox regression hazard ratio (HR).
Measured as hazard ratio (i.e., the hazard for other cancers in the Melatonin arm divided by the hazard in the control group) with relevant covariates (e.g., tumor size, patient age, BAP-1 expression), with 95 % confidence interval.
Time frame: 5 years
Number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs) in Melatonin vs. Control arm, as assessed by CTCAE v5.0.
Frequency of adverse events (AEs) and serious adverse events (SAEs) in the Melatonin vs. Control arm, evaluated as relative risk (RR) with 95 % confidence interval.
Time frame: 5 years
Interim analysis: Number of patients that develop metastases in Melatonin vs. Control arm, evaluated as relative risk (RR).
Measured as relative risk (i.e., the incidence rate of metastasis in the Melatonin arm divided by the incidence rate in the control group), with 95 % confidence interval.
Time frame: 3 years
Interim analysis: Overall survival (OS) in Melatonin vs. Control arm, evaluated with the Log-rank test.
Overall survival in the Melatonin vs. Control arm
Time frame: 3 years
Plan to share: No
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