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New treatment option for Uveal Melanoma
Official title Adjuvant Melatonin for Uveal Melanoma
ClinicalTrials.gov ID: NCT05502900
What this study is testing
What is Melatonin?
Melatonin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for uveal melanoma.
Also referred to as Melatonin AGB Pharma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient is ≥18 years
- The patient has given his/her written informed consent to participate in the trial.
- The patient has a melanoma originating in the choroid or in the ciliary body, as diagnosed by clinical methods and/or histological examination. AND...
- The patient's tumor is of size category T3d or higher, or stage IIIB or IIIC according to the American Joint Committee on Cancer (AJCC, version 8)...
- The patient's tumor is large according to modified criteria from the Collaborative Ocular Melanoma Study (COMS), i.e. largest basal diameter \>16 mm...
You likely can't join if
- Oversensitivity or allergy to Melatonin or any of the excipients in the tablet.
- The patient has metastatic disease, detectable with radiological examinations or any other method (development of metastases after recruitment to the...
- The patient is unable to provide informed consent.
- The patient has decreased liver function (e.g., liver cirrhosis or hepatitis)
- The patient is pregnant or a fertile woman (Women of child-bearing potential, WOCBP). Fertility is defined as the time between menarche and menopause...
- The patient is breast feeding or is planning to breastfeed before the end of the trial. Women that are included in the trial and begin to breastfeed...
See the full eligibility criteria
- The patient is ≥18 years
- The patient has given his/her written informed consent to participate in the trial.
- 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:
- The patient's tumor is of size category T3d or higher, or stage IIIB or IIIC according to the American Joint Committee on Cancer (AJCC, version 8) criteria.
- The patient's tumor is large according to modified criteria from the Collaborative Ocular Melanoma Study (COMS), i.e. largest basal diameter \>16 mm or apical thickness \>8 mm.
- The patient's tumor was of size category T2a before plaque brachytherapy and has then recurred.
- The patient's tumor has an epithelioid cell type (\>5 epithelioid cells per high power field and \>90 % of tumor cells epithelioid).
- The patient's tumor has a low immunohistochemical expression of BAP1.
- The patient's tumor has more than 9 mitoses per high power field.
- The patient has \>60 % risk of metastases within 5 years, as determined with another published and validated prognostic test (e.g. gene expression class 2).
- If the patient is already being treated with Melatonin, a two-week wash out period will be applied before randomization.
- Oversensitivity or allergy to Melatonin or any of the excipients in the tablet.
- The patient has metastatic disease, detectable with radiological examinations or any other method (development of metastases after recruitment to the trial does not disqualify the patient from participation).
- The patient is unable to provide informed consent.
- The patient has decreased liver function (e.g., liver cirrhosis or hepatitis)
- The patient is pregnant or a fertile woman (Women of child-bearing potential, WOCBP). Fertility is defined as the time between menarche and menopause for women that are not permanently sterile by hysterectomy, bilateral...
- The patient is breast feeding or is planning to breastfeed before the end of the trial. Women that are included in the trial and begin to breastfeed before the end of the trial must resign from the trial.
- The patient has epilepsy.
- The patient is being treated (for more than 4 weeks) with CYP1A2 inhibitors Fluvoxamine, Ciprofloxacin, Norfloxacin, or Verapamil, with combined hormonal contraception (containing etinylestradiole and progestin), with...
- The primary UM was diagnosed more than 12 months ago.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Stockholm County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Stockholm County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.