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:

• Adults aged 18 or older at the time of signing consent forms
• People who are able to read, understand, and sign a consent form before any study procedures begin
• People who are willing to have tumor tissue samples (biopsies) taken before and after treatment with the study drug Tebentafusp
• People who have not previously received any treatment for uveal melanoma (a type of eye cancer), where the tumor is a larger size (classified as T3 or T4) and cannot be surgically removed without completely removing the eye
• People for whom there is no surgical option to remove the tumor while keeping the eye
• People whose uveal melanoma has been confirmed through clinical assessment or cell sample testing
• People who carry a specific genetic marker called HLA-A*02:01 (a blood test can determine this)
• People expected to live for at least 12 weeks, as assessed by the treating doctor
• People who are generally well enough to carry out normal daily activities, or who have some limitations but are still able to walk around and care for themselves (scored 0 or 1 on a standard health scale)
• People whose other medical conditions are well-managed and have been stable for at least 28 days before starting the study drug
• People without any personal, family, social, or location-related circumstances that might make it difficult to follow the study schedule

Who may not be able to join:

• People whose uveal melanoma is causing urgent symptoms that require immediate treatment such as surgical removal of the eye
• People whose cancer has spread to other parts of the body
• People who have previously been treated with Tebentafusp
• People with certain blood test results outside acceptable ranges, including problems with kidney function, low protein levels, liver function abnormalities, low blood cell counts, or certain mineral imbalances that cannot be corrected — a doctor can review specific values (confirm with trial site)
• People with a history of severe allergic reactions (such as anaphylaxis) to biological medicines or monoclonal antibody drugs
• People with serious heart conditions, including significantly reduced heart pumping function, poorly controlled heart failure, uncontrolled high blood pressure, uncontrolled irregular heartbeat, or a heart attack or unstable chest pain within the past 6 months
• People currently being treated with antibiotics for an active infection (those who finished a course of antibiotics at least one week before starting the study may still be considered)
• People with a history of HIV infection, unless they meet specific conditions including being on stable HIV treatment for more than 3 months, having adequate immune cell counts, and having an undetectable viral level at screening (confirm with trial site)
• People with known active Hepatitis B infection, unless they are on stable antiviral treatment and their viral level is undetectable at screening
• People with known active Hepatitis C infection, unless they have received curative treatment and the virus is no longer detectable
• People with a current or recent other cancer, with some exceptions such as cancers that were fully treated and have not returned within the past 2 years, fully removed skin cancers, slow-growing cancers that have never needed treatment, or fully removed pre-cancerous tissue (confirm with trial site)
• People with any other medical condition that the study doctor or study sponsor believes would make participation unsafe or impractical
• People currently taking steroid tablets or injections, or other medicines that suppress the immune system — topical or inhaled steroids and eye or ear drops are generally acceptable
• People who have had major surgery within 2 weeks before starting the study drug
• People who have had radiotherapy within 2 weeks before starting the study drug
• People who have used certain medicines to boost blood cell production within 2 weeks before starting the study drug
• 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 surgically sterilised, unless highly effective contraception is used during the study and for 6 months after the last dose
• Male participants who have not been surgically sterilised must use double-barrier contraception from enrolment through treatment and for 6 months after the last dose

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