Using Melatonin to Prevent Metastases in Uveal Melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of Melatonin as an adjuvant treatment for patients diagnosed with primary uveal melanoma (UM) to prevent or delay the onset of metastases. A total of 100 patients will be randomized to receive either Melatonin tablets at night or a control treatment, with follow-up conducted over five years. The primary outcome measure will be the comparison of metastasis development between the two groups at the end of the study period. The trial is conducted at St. Erik Eye Hospital in Stockholm, Sweden, which specializes in uveal melanoma treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient is ≥18 years
2. The patient has given his/her written informed consent to participate in the trial.
3. 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:
4. 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.
5. 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.
6. The patient's tumor was of size category T2a before plaque brachytherapy and has then recurred.
7. The patient's tumor has an epithelioid cell type (\>5 epithelioid cells per high power field and \>90 % of tumor cells epithelioid).
8. The patient's tumor has a low immunohistochemical expression of BAP1.
9. The patient's tumor has more than 9 mitoses per high power field.
10. 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).
11. If the patient is already being treated with Melatonin, a two-week wash out period will be applied before randomization.

Exclusion Criteria:

1. Oversensitivity or allergy to Melatonin or any of the excipients in the tablet.
2. 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).
3. The patient is unable to provide informed consent.
4. The patient has decreased liver function (e.g., liver cirrhosis or hepatitis)
5. 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 salpingectomy, or bilateral oophorectomy. Menopause is defined as absence of menstruation for 12 months or longer without other cause.
6. 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.
7. The patient has epilepsy.
8. 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 hormonal substitution therapy, with 5- or 8-metoxypsoralene or cimetidine. If a patient starts using any of these substances for more than 4 weeks after recruitment to the trial, he or she does not need to resign from the trial but may pause the use of Melatonin, and then restart after the use of the other substance has ceased. Concurrent treatment with CYP1A2 inducers including carbamazepine, fenytoine, rifampicin, omeprazole, calcium antagonists, benzodiazepine-related hypnotics, non-steroid anti-inflammatory drugs (NSAIDs) and beta blockers is not an exclusion criterium. Concurrent treatment with warfarin or other vitamin K antagonists is not an exclusion criterium, but requires information to the patient and discussion about dose adjustments with the prescribing physician.
9. The primary UM was diagnosed more than 12 months ago.

Where it's running

• St. Erik Eye Hospital
  Stockholm, Stockholm County, Sweden Recruiting

Study contacts

• Principal investigator: Gustav Stålhammar, MD PhD — St. Erik Eye Hospital and Karolinska Institutet
• Study coordinator: Gustav Stålhammar, MD PhD
• Email: gustav.stalhammar@ki.se
• Phone: 0046812323000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-precision radiosurgery followed by minimally invasive eye-sparing surgery for prominent uveal melanoma

  This study tests a modern, precise radiosurgery approach followed by a minimally invasive surgery to see if it can control the tumor while preserving vision in patients with high-prominence uveal melanoma.

  Recruiting at 3 sites University Hospital, Essen · Essen, Germany / NRW and 2 other locations · NCT07913412

• Adjuvant darovasertib and crizotinib in high-risk non-metastatic uveal melanoma

  Researchers are testing whether adding darovasertib and crizotinib after local eye tumor treatment can help prevent recurrence in people with high-risk, non-metastatic uveal melanoma.

  Recruiting at 4 sites Phase 3 IDEAYA Biosciences · Scottsdale, Arizona and 12 other locations · NCT07804186

• Neoadjuvant immunotherapy for high-risk eye melanoma

  This trial tests whether giving nivolumab and ipilimumab before surgery is safe and feasible for adults with high-risk uveal melanoma.

  Recruiting Phase 1 Herlev Hospital · Herlev, Herlev · NCT07501117

• Immune response after delivering melphalan directly to the liver for uveal (eye) melanoma that has spread to the liver.

  This test will see how the liver's immune system responds when people with uveal melanoma that has spread to the liver receive melphalan delivered directly to the liver through percutaneous hepatic perfusion.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07364474

• NBM-BMX for adults with metastatic uveal melanoma — dose-finding and safety

  This study will test whether taking the oral drug NBM-BMX twice daily is safe, how the body handles it, and whether it can slow or shrink tumors in adults with metastatic uveal melanoma while finding the best dose.

  Recruiting at 3 sites Phase 1/2 Novelwise Pharmaceutical Corporation · Scottsdale, Arizona and 2 other locations · NCT07136181

• Adding IL-2 to tebentafusp to overcome resistance in uveal melanoma

  This trial tests whether giving interleukin‑2 (IL‑2) together with tebentafusp can help people with HLA‑A*02:01 metastatic uveal melanoma who progressed on tebentafusp.

  Recruiting Phase 1/2 St Vincent's Hospital, Sydney · Sydney, New South Wales and 1 other locations · NCT07063875

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.