Phase 3 Melanoma Trial, Recruiting

Written by an AI model from 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 diagnosed with uveal melanoma (a type of eye cancer) that has not spread to other parts of the body, and whose cancer is not in the iris part of the eye, and who have already completed surgery or radiotherapy as their main treatment
• People whose main treatment was completed less than 11 weeks ago (with randomisation into the trial happening no later than 12 weeks after treatment ended)
• People whose cancer is considered high-risk, either because of its stage (stage III based on AJCC8 classification) or because of specific genetic features found in the tumour (monosomy 3 or GEP class 2); people with stage I or II may be considered if they meet the genetic criteria used by the trial site (confirm with trial site)
• People with a general health and activity level rated as 0 or 1 on the ECOG scale — meaning fully active or able to carry out light activity (confirm with trial site)
• People aged 18 years or older
• People who test positive for a specific immune system marker called HLA-A*02:01, as tested by the local trial site
• People with no signs of the eye cancer returning, confirmed by required scans taken within 4 weeks before joining the trial
• People whose kidneys, liver, and other organs are working well enough to safely take part (confirm with trial site)
• Women who have gone through menopause, or women who could become pregnant and have had a negative pregnancy test within 3 days before joining the trial
• People who are able to have children and agree to use a highly reliable form of contraception during treatment and for at least 6 months after the last dose
• Women who are currently breastfeeding and agree to stop breastfeeding before the first dose and for at least 6 months after the last dose
• People who are willing and able to give written informed consent to participate

Who may not be able to join:

• People with significant heart problems, including moderate to severe heart failure, poorly controlled high blood pressure, or a heart rhythm disorder currently needing medication
• People with a heart electrical reading (ECG) showing a measurement called QTcF above 470 milliseconds, or those with a genetic condition called long QT syndrome, confirmed by at least 3 ECG readings taken within 30 minutes
• People who have had a heart attack or unstable chest pain (angina) within the 6 months before screening
• People with an active infection currently requiring antibiotic treatment through a drip or injection; people who have completed such antibiotic treatment must have finished it at least 1 week before joining the trial
• People with serious uncontrolled illness or active infection, including active hepatitis B, hepatitis C, or HIV with more than 200 virus copies per millilitre of blood, active bleeding disorders, or a history of kidney transplant
• People with a history of hepatitis B may still be considered if they have been on stable antiviral treatment for more than 4 weeks before the first dose and their virus level is undetectable at screening
• People with a history of hepatitis C may still be considered if they have received curative treatment and their virus level is undetectable at screening
• People who have had another type of cancer in the past, with some exceptions: non-melanoma skin cancers and cervical cancer in situ that have been fully treated may be acceptable; other previous cancers treated with curative intent more than 3 years ago may also be considered if the person is not on any cancer treatment, has a low risk of that cancer returning (below 10% as assessed by the trial doctor), and has no lasting side effects from that treatment
• People with an active autoimmune disease (where the immune system attacks the body) that requires immune-suppressing medication, within the past 2 years — though several conditions are exceptions and may still be permitted, including vitiligo, hair loss (alopecia), well-managed underactive thyroid, stable adrenal insufficiency, psoriasis, childhood asthma or allergies that have resolved, well-controlled asthma, and type 1 diabetes
• People whose personal, psychological, family, social, or geographic circumstances may make it difficult to follow the trial schedule and requirements
• People who are unable to have contrast dye used in scans, or who cannot have MRI or CT scans for any reason

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