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:

• You are 18 years of age or older and able to sign a consent form agreeing to take part
• You have been diagnosed with uveal melanoma (a type of eye cancer) that has spread to other parts of the body, confirmed by a tissue or cell sample test
• Your cancer may be newly diagnosed with no prior treatment, or it may have continued to grow or spread despite previous treatment
• If you have a specific immune marker called HLA-A*02:01 and have not had prior treatment, your doctor must provide a reason why a drug called tebentafusp is not the right first treatment for you, or that you cannot tolerate it
• Your cancer can be measured on scans according to standard criteria (called RECIST v1.1)
• You are generally able to carry out basic daily activities (with little or no limitation) and are expected to live for more than 3 months
• Your kidneys, liver, bone marrow, and other organs are working well enough at the time of screening
• You are using appropriate contraception if you are able to have children (for both men and women)

If you are joining the part of the trial that includes the drug crizotinib, you also need to meet these additional requirements:

• Any previous chemotherapy, other treatments, or major surgeries were completed at least 4 weeks before starting crizotinib
• If you have nerve damage (tingling, numbness, or weakness), it must be very mild before starting crizotinib
• You have at least one area of cancer that can be safely biopsied (sampled with a needle) at least twice

Who may not be able to join:

• You have previously been treated with a type of drug called a PKC inhibitor
• Your tumor has a specific genetic feature (MSI-H/dMMR) and you have never received immunotherapy drugs
• You have brain tumours that are causing symptoms
• You are still experiencing side effects from a previous cancer treatment that have not gone away
• You have HIV/AIDS, hepatitis B, or hepatitis C
• You currently have an active infection that requires treatment
• You have had surgery or radiation therapy very recently (confirm with trial site for exact timeframes)
• You have had your stomach or part of your upper bowel removed, or you have a condition affecting your digestive system that could affect how you absorb medication
• You are pregnant or breastfeeding
• You have significant heart problems (confirm with trial site for specifics)
• You are taking certain medications that cannot be stopped before joining the trial
• If you would be taking a capsule form of the study drug or crizotinib, you have an allergy to mammalian meat products or gelatin

If joining the crizotinib combination part, you also cannot join if:

• You have previously had treatment specifically targeting proteins called ALK, MET, or ROS1
• You have compression or pressure on your spinal cord
• You have a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease)
• You have a history of fainting (syncope)
• You have had a blood clot or stroke within the past 12 weeks

If joining the optional pravastatin sub-study, you also cannot join if:

• You have taken a statin medication or a related drug within the past 7 days and cannot stop taking it
• You are taking medications that interfere with how pravastatin is processed by your body
• You have a known reason you should not take statins, or you are allergic to any ingredient in pravastatin
• You have active liver disease

If joining the optional drug interaction (DDI cocktail) sub-study, you also cannot join if:

• You have taken certain specific medications (including bupropion, repaglinide, omeprazole, midazolam, and others) within 7 days before a specific study visit
• You have taken vitamin B6 supplements, grapefruit or grapefruit juice, or Seville orange juice within 7 days before a specific study visit
• You are taking certain medications that affect how the liver processes drugs (confirm with trial site for the full list and timeframes)

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