Phase 2 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 who have been diagnosed with metastatic uveal melanoma (a type of eye cancer that has spread) confirmed through a laboratory test of tissue or cells, and who have not yet received treatment for it.
• People who carry a specific genetic marker called HLA-A*0201, confirmed through an approved blood test (if this has not already been tested, a blood sample must be submitted during the screening process).
• People who are willing to have a blood test called a Signatera assay, which looks for cancer DNA in the blood.
• People who are able to provide a fresh tissue biopsy from a tumour that has not been previously treated with radiation.
• People whose organs (such as liver, kidneys, and bone marrow) are functioning well enough based on blood tests taken within 4 weeks before starting the trial.
• People who have not previously received systemic (whole-body) treatment for metastatic or advanced disease, including chemotherapy or targeted therapy, and who have never received the drug tebentafusp.
• People who have not previously received certain immunotherapy drugs (such as PD-1, CTLA-4, or LAG-3 checkpoint inhibitors) in the lead-up to or after surgery, unless that treatment was given more than 6 months before the metastatic diagnosis was made.
• People who have not previously received any treatment directed at the liver or regional disease, such as chemotherapy, radiation, or procedures to block blood supply to tumours.
• People who previously had surgery to remove a small number of metastatic tumours may still be eligible.
• People who previously received treatment before or after surgery when the cancer was localised (not spread) may still be eligible.
• People whose doctor estimates they have a life expectancy of more than 6 months.
• People who are generally in good physical condition, rated 0 or 1 on a standard scale used by doctors to measure how much a patient's cancer affects their daily activities (confirm with trial site).
• People who have at least one tumour that can be measured on scans, according to standard criteria called RECIST v1.1.
• People whose other medical conditions are well-managed and stable for at least 28 days before starting the trial, in the opinion of the treating doctor.

Who may not be able to join:

• People who have had a severe allergic reaction (such as anaphylaxis) to a biological drug or monoclonal antibody in the past.
• People with serious heart conditions, including poorly controlled heart failure, uncontrolled high blood pressure, or a significant heart rhythm problem currently requiring treatment.
• People whose heart electrical activity measurement (called QTcF on an ECG) is above a certain threshold, or who have an inherited condition called long QT syndrome (confirm with trial site).
• People who had a heart attack or unstable chest pain within 6 months before screening.
• People who have brain or central nervous system (CNS) metastases that are causing symptoms, have not been treated, or required steroid medication within the 3 weeks before starting the trial.
• People with active brain metastases that have not been treated (note: those whose brain metastases were fully treated with surgery or targeted radiation, with no signs of growth for at least 2 weeks, may still be considered).
• People with cancer that has spread to the lining around the brain or spinal cord (called leptomeningeal disease).
• People with an active infection currently requiring antibiotic treatment (people who finished a course of antibiotics at least 1 week before starting the trial may still be considered).
• People with a current uncontrolled HIV, hepatitis B, or hepatitis C infection (those with a successfully treated or well-controlled infection under certain conditions may still be considered — confirm with trial site).
• People who currently have or recently had another type of cancer, with some exceptions such as certain fully removed skin cancers, cancers that were cured more than 2 years ago, or very slow-growing cancers that have never needed treatment (confirm with trial site).
• People with any medical condition that, in the doctor's judgement, would make participation unsafe or not practical.
• People currently taking steroid tablets or injections, or any other medication that suppresses the immune system (topical, eye drop, ear drop, inhaled, or joint-injected steroids are generally acceptable).
• People with a history of certain autoimmune conditions, including lung scarring (interstitial lung disease), lung inflammation (pneumonitis) that required steroids, or inflammatory bowel disease or colitis (people with other autoimmune conditions who are stable on a low dose of hormonal replacement steroids and have no symptoms may still be considered — confirm with trial site).
• People who have had major surgery within 2 weeks before starting the trial (minor procedures such as biopsies or insertion of a drip line are generally not considered major surgery).
• People who have had radiation therapy within 2 weeks before starting the trial, unless it was a limited course of palliative radiation for pain relief.
• People who have received certain blood cell-stimulating injections (such as G-CSF or GM-CSF) within 2 weeks before starting the trial.
• People who are pregnant, likely to become pregnant, or currently breastfeeding.
• Women who could become pregnant and are sexually active with a male partner who has not been sterilised, unless highly effective contraception is used during the trial and for 6 months after the last dose.
• Male participants who are not surgically sterile must use two forms of contraception from enrolment through to 6 months after the last dose.
• People who have received a live or weakened live vaccine within 2 weeks before starting the trial.

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