Phase 3 Melanoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older
• People who have given written consent to take part in the trial
• People diagnosed with a melanoma (a type of cancer) starting in a specific part of the eye called the choroid or the ciliary body, confirmed by clinical assessment and/or laboratory examination of tissue
• And at least one of the following also applies:
• People whose tumour is classified as a certain size or stage (T3d or higher, or stage IIIB or IIIC) based on a standard cancer staging system called AJCC version 8 (confirm with trial site)
• People whose tumour is considered large, meaning its widest base is more than 16 mm across or it is more than 8 mm tall, based on a set of guidelines called the COMS criteria
• People whose tumour was previously treated with a type of radiation therapy called plaque brachytherapy at a smaller size category (T2a), and has since come back
• People whose tumour contains a particular type of cancer cell called epithelioid cells, making up more than 90% of the tumour with more than 5 of these cells visible per microscope field
• People whose tumour shows low levels of a protein called BAP1, as measured by a laboratory test
• People whose tumour shows more than 9 cell divisions (mitoses) per microscope field, which is a measure of how fast the tumour is growing
• People whose tumour carries a greater than 60% estimated risk of spreading within 5 years, as measured by another recognised and validated test (for example, a gene expression test that gives a "class 2" result)
• People already taking melatonin supplements may still be considered, provided there is a two-week break from melatonin before the trial begins

Who may not be able to join:

• People who have a known sensitivity or allergy to melatonin or any ingredient in the trial tablet
• People whose cancer has already spread (metastasised) to other parts of the body at the time of joining — though if spreading is detected after joining, that does not automatically remove a person from the trial
• People who are not able to give informed consent to participate
• People with reduced liver function, such as liver cirrhosis or hepatitis
• People who are pregnant, or women who are able to become pregnant — this includes women from the time their periods begin until 12 months after their last period (without another medical cause), unless they have had a surgical procedure to permanently prevent pregnancy (such as removal of the uterus, both fallopian tubes, or both ovaries)
• People who are breastfeeding or planning to breastfeed before the trial ends — if breastfeeding begins after joining, the person would need to leave the trial
• People who have epilepsy
• People who have been taking certain medications for more than four weeks, including specific antibiotics (ciprofloxacin, norfloxacin), an antidepressant (fluvoxamine), a heart medication (verapamil), certain hormonal contraceptives containing ethinylestradiol and progestin, hormonal replacement therapy, certain skin treatment medications (5- or 8-methoxypsoralen), or a stomach medication (cimetidine) — if any of these are started after joining the trial, the trial site may pause melatonin rather than removing the person from the trial (confirm with trial site)
• People whose eye melanoma was first diagnosed more than 12 months ago

Important: Always verify eligibility with the trial site directly before applying.