Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05502900

Adjuvant Melatonin for Uveal Melanoma

Led by Gustav Stalhammar · Updated on 2025-05-15

100

Participants Needed

1

Research Sites

430 weeks

Total Duration

On this page

Sponsors

G

Gustav Stalhammar

Lead Sponsor

K

Karolinska Trial Alliance

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Adjuvant Melatonin for Uveal Melanoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient is 18 years or older
  • The patient has given written informed consent to participate in the trial
  • The patient has melanoma originating in the choroid or ciliary body diagnosed by clinical or histological methods
  • The tumor is size category T3d or higher, or stage IIIB or IIIC per AJCC version 8
  • OR the tumor is large by COMS criteria (largest basal diameter >16 mm or apical thickness >8 mm)
  • OR the tumor was size category T2a before plaque brachytherapy and has recurred
  • OR the tumor has epithelioid cell type (>5 epithelioid cells per high power field and >90% tumor cells epithelioid)
  • OR the tumor shows low immunohistochemical expression of BAP1
  • OR the tumor has more than 9 mitoses per high power field
  • OR the patient has >60% risk of metastases within 5 years by a validated prognostic test
  • If already treated with Melatonin, a two-week washout period must be completed before randomization
Not Eligible

You will not qualify if you...

  • Allergy or oversensitivity to Melatonin or its tablet ingredients
  • Presence of detectable metastatic disease by any method
  • Inability to provide informed consent
  • Decreased liver function (e.g., liver cirrhosis or hepatitis)
  • Pregnant women or women of child-bearing potential
  • Breastfeeding or planning to breastfeed before trial end
  • Diagnosis of epilepsy
  • Treatment for more than 4 weeks with certain CYP1A2 inhibitors or hormonal therapies as listed
  • Primary UM diagnosis older than 12 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Erik Eye Hospital

Stockholm, Stockholm County, Sweden, 17164

Actively Recruiting

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Research Team

G

Gustav Stålhammar, MD PhD

CONTACT

A

Anna Hagström, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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