Phase 1 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 advanced or metastatic skin melanoma, or any type of sarcoma, confirmed by a tissue sample analysis.
• People with sarcoma who have already tried at least one standard treatment that did not work, stopped working, or caused intolerable side effects.
• People with metastatic melanoma that does not have a BRAF gene mutation, who have tried at least one standard treatment that did not work, stopped working, or caused intolerable side effects.
• People with metastatic melanoma that does have a BRAF gene mutation, who have tried at least two standard treatments that did not work, stopped working, or caused intolerable side effects.
• People whose tumour tissue tests positive for a protein called NY-ESO-1 (present in at least 50% of the sampled tissue) and who carry specific immune system markers called HLA-A*0201 and/or HLA-A*0205, confirmed by specialised genetic testing.
• People aged 18 years or older.
• People who are able to undergo a procedure called apheresis, where blood cells are collected from the body.
• People who have at least one tumour lesion that can be safely biopsied (sampled) around Day 30 of the trial.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People with a life expectancy of more than 12 weeks.
• People whose cancer can be measured on a scan according to standard criteria.
• People with adequate functioning of major organs such as the liver, kidneys, and bone marrow.

Who may not be able to join:

• People who currently have another active cancer diagnosis.
• People with brain metastases (cancer that has spread to the brain) that are causing symptoms or have not been treated. People whose brain metastases have been fully treated, are stable, have no new lesions, and do not require ongoing steroid medication may be considered after discussion with the lead investigator.
• People with a history of a lung scarring condition called idiopathic pulmonary fibrosis, or who currently have active inflammation of the lungs from any cause. A history of lung scarring specifically from radiation treatment is allowed.
• People who have had a heart attack or unstable chest pain (angina) within the six months before joining the trial.
• People who have previously had a stem cell transplant from a donor, or an organ transplant.
• People who have had a serious active infection in the two weeks before the apheresis procedure.
• People who need to take regular immune-suppressing medications (such as steroids or certain other drugs that reduce immune system activity). These medications must have been stopped at least two weeks before apheresis.
• People who have had a severe allergic reaction to any ingredient in the study treatments.
• People who are pregnant or breastfeeding.
• People for whom there are concerns about reliably following the contraception requirements of the trial.
• People with a serious underlying health condition that could interfere with the trial treatment or its potential side effects.

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