Phase 2 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 who have been diagnosed with uveal melanoma (a type of eye cancer) where the tumour measures at least 12 mm across at its widest point, as assessed by their treating doctor.
• People whose main treatment for uveal melanoma (such as surgery or radiation) was completed within 183 days (about 6 months) of starting the trial treatment.
• People whose uveal melanoma has been classified as "high-risk" (called Class 2) based on a specific genetic test of the tumour (DecisionDx-UM gene expression profiling).
• People with no signs that the cancer has spread to other parts of the body.
• People aged 18 years or older.
• People who are generally well enough to carry out normal daily activities, with little or no limitation (as measured by a standard medical scale called ECOG performance status 0–1).
• People with a life expectancy of more than 3 months.
• People who are able to swallow tablets or capsules and keep them down, and who do not have significant digestive system problems that could affect how the body absorbs medication.
• People whose blood test results show that major organs such as the liver, kidneys, and bone marrow are functioning adequately, as determined by the treating doctor.
• People who are able and willing to use reliable contraception (hormonal or barrier methods, or abstinence) from the start of the trial until 6 months after completing treatment, and women who could become pregnant must have a negative pregnancy test within 14 days before starting the trial.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who have another cancer that is currently growing or needs active treatment (some exceptions apply, such as certain treated skin cancers, early-stage cervical or breast changes, or a previous cancer with no signs of return for 2 or more years — confirm with trial site).
• People who have had major surgery or extensive radiation treatment, other than what was needed to treat their uveal melanoma.
• People who have already received any additional treatment aimed at preventing uveal melanoma from coming back after their main treatment.
• People who have previously taken a type of drug called an HDAC inhibitor.
• People who cannot stop taking certain medications that strongly interact with the way the trial drug is processed by the body (specific drug classes called potent CYP3A4/A5 and CYP2C9 inhibitors, or warfarin) — the trial team would need to discuss this before any decision is made.
• People who have taken another experimental drug within 28 days, or within five half-lives of that drug (whichever is shorter), before starting the trial, with a minimum gap of at least 14 days.
• People who are known to have had a serious allergic or unusual reaction to drugs that are chemically similar to the trial drug, quisinostat.
• People who have a particular abnormality on a heart tracing (ECG) called a prolonged QTc interval (480 milliseconds or more), or who have a history of a condition called long QT syndrome.
• People with a known active HIV, Hepatitis B, or Hepatitis C infection (people with fully cleared Hepatitis B or C, confirmed by undetectable virus levels on testing, may be considered — confirm with trial site).
• People whose heart pumping function falls outside the normal range, or who have a history of a significant irregular heartbeat as assessed by a heart specialist.
• People with serious uncontrolled health conditions, including active infections, heart failure, unstable chest pain, significant heart disease classified as NYHA Class 2–4, or mental health or personal circumstances that would make it difficult to follow the trial requirements.
• People with any other condition, treatment, or test result that the treating doctor believes would interfere with the trial results, affect the person's ability to complete the trial, or make participation not in the person's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to meet the trial's requirements.
• People who do not have the ability to make informed decisions about their own care.

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