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 metastatic uveal melanoma (a type of eye cancer that has spread) that is located mainly in the liver, confirmed by a pathology review
• People whose liver function blood test results fall within specific acceptable ranges — serum bilirubin below 2 mg/dL, and liver enzymes (AST and ALT) less than 5 times the upper limit of normal
• People whose preparatory angiogram procedure (an imaging test of blood vessels) shows that a type of radiation treatment delivered through the liver's blood vessels (radioembolization) can be done safely
• People who test positive for a specific genetic marker called HLA-A*02:01 (a marker found on immune cells)
• People aged 18 years or older
• People who are able to understand and sign a written consent form
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work)
• People whose cancer can be measured or tracked on scans, according to standard medical guidelines

Who may not be able to join:

• People who have any individual tumour larger than 8 cm
• People whose total bilirubin (a liver-related blood marker) is above 1.5 times the upper limit of normal — or, for people with a condition called Gilbert's syndrome, above 3 times the upper limit of normal, or with direct bilirubin above 1.5 times the upper limit of normal
• People whose blood test results fall outside acceptable ranges, including: liver enzymes (ALT or AST) above 3 times the upper limit of normal; low white blood cell counts (neutrophils or lymphocytes below specific levels); platelet count below 75 × 10⁹ per litre; or haemoglobin (red blood cell level) below 8 g/dL
• People whose angiogram shows abnormal blood vessel connections (shunting) that would make radioembolization unsafe
• People who have had a severe allergic reaction (such as anaphylaxis) to a biologic medicine or monoclonal antibody in the past
• People with significant heart problems, including: moderate-to-severe heart failure; uncontrolled high blood pressure; a history of serious heart rhythm problems requiring treatment; uncontrolled irregular heartbeat (atrial fibrillation); an abnormal heart electrical reading (QT interval) above a specific threshold; or a heart attack or unstable chest pain within the past 6 months
• People who have active or untreated cancer spread to the brain, or brain metastases that have required steroid treatment within the 14 days before starting the study
• People with an active infection currently being treated with antibiotics — antibiotic treatment must have been completed at least one week before the first study drug dose
• People with a known history of HIV infection
• People with an active hepatitis B or hepatitis C infection
• People who have had another active cancer, with some exceptions: cancers treated successfully with no recurrence in the past 2 years, certain minor skin cancers that were completely removed, cancers considered slow-growing that have never needed treatment, or completely removed non-invasive cancers (carcinoma in situ)
• People with any other medical condition that the trial investigators or sponsor believe would make participation unsafe or interfere with the study
• People who have received steroid medications or other immune-suppressing drugs within 2 weeks of the planned first dose — with certain limited exceptions permitted (confirm with trial site)
• People with a morning cortisol blood level below the normal range, unless they have a known adrenal condition and are already on a stable replacement dose
• People with a history of interstitial lung disease (scarring or inflammation of the lungs)
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People with an active autoimmune disease requiring immune-suppressing treatment, including inflammatory bowel conditions such as ulcerative colitis or Crohn's disease, within the past 2 years — with certain exceptions permitted (confirm with trial site)
• People who have had major surgery within 2 weeks of the planned first dose (minor procedures such as biopsies or insertion of a port are not considered major surgery)
• People who have received radiation therapy within 2 weeks of the first dose, except for limited palliative radiotherapy (such as for bone pain)
• People who have received certain white blood cell growth factor injections within 3 weeks before starting treatment (confirm with trial site for details on red blood cell stimulating agents)
• People who have received a live or weakened live vaccine within 28 days before the first dose — non-live vaccines such as mRNA COVID-19 vaccines are permitted but must not be given within specific time windows around study treatment (confirm with trial site)
• People who are pregnant, likely to become pregnant, or who are breastfeeding
• Women who could become pregnant and are sexually active with a non-sterilised male partner, unless highly effective contraception is used throughout treatment and for 6 months after the last dose
• Male patients who are not surgically sterile, unless double-barrier contraception is used from enrolment through treatment and for 6 months after the last dose
• People who have previously had radioembolization or any other liver-directed treatment (including chemotherapy or embolization) to the same area of the liver
• People who are not able to make informed decisions for themselves

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