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 aged 18 or older
• People who have been diagnosed (through a tissue or cell sample) with uveal melanoma (a type of eye cancer) that has spread to the liver, with at least one liver tumour measuring 10mm or more on a CT or MRI scan. Spread to other areas of the body is also allowed.
• People whose tumour size fits one of two groups: Part 1 is for people whose tumours make up less than 50% of the liver, with the largest tumour being 5cm or smaller; Part 2 is for people with a largest tumour greater than 5cm, cancer that has spread more widely, or tumours taking up 50% or more of the liver (confirm with trial site which group applies)
• People who have not previously been treated with the drug tebentafusp-tebn
• For Part 1: People who have not yet had any systemic (whole-body) treatment for their metastatic disease. Previous surgery or ablation for limited spread, or palliative radiation to non-target areas, is allowed.
• For Part 2: People who have had up to two prior lines of treatment, which may include chemotherapy, immunotherapy, targeted therapy, or liver-directed treatments such as surgery, ablation, immunoembolisation, or radioembolisation. Chemoembolisation is not allowed in Part 2.
• People who test positive for a specific genetic marker called HLA-A*0201
• People who are in generally good physical condition, rated 0 or 1 on a standard medical activity scale (ECOG), meaning they are either fully active or have minor limitations
• People whose life expectancy is estimated by their doctor to be greater than 3 months
• People whose blood counts and organ function fall within acceptable ranges, including adequate platelet count, haemoglobin, white blood cell count, liver enzyme levels, bilirubin, kidney function, clotting time, and electrolyte levels (confirm specific values with trial site). People with a known inherited condition affecting bilirubin levels, such as Gilbert syndrome, may still be eligible at the treating doctor's discretion.
• Women who are not pregnant and not breastfeeding
• Women who could become pregnant must have a negative pregnancy test within 14 days before starting the trial, and must agree to use reliable contraception during the trial and for 6 months after the last dose
• Men must be surgically sterile or agree to use two forms of contraception from enrolment through treatment and for 6 months after finishing the trial
• People who are able to understand the study and are willing to sign a written consent form

Who may not be able to join:

• People who do not meet the inclusion criteria listed above
• People who have previously used the drug tebentafusp-tebn
• People who have had chemoembolisation as a prior liver treatment (Part 2 only)
• People with a history of a serious allergic reaction to biologic drugs, monoclonal antibodies, or iodinated contrast agents used in imaging
• People who have active liver failure symptoms, such as fluid build-up in the abdomen or confusion related to liver disease
• People with brain or spinal cord (central nervous system) spread that is causing symptoms, has not been treated, or required steroid medication within the past 21 days. People with previously treated brain spread may be considered if there has been no sign of progression for at least 4 weeks on MRI.
• People with a history of another cancer, unless they have been cancer-free for at least 3 years, had a fully removed non-melanoma skin cancer, have a slow-growing secondary cancer not needing treatment, or had a fully removed very early-stage cancer (carcinoma in situ)
• People who have had major surgery within 2 weeks before the first dose (minor procedures such as biopsies or insertion of a port or feeding tube are generally not considered major surgery)
• People who have had radiation therapy within 2 weeks before the first dose, except for limited palliative radiation (such as for bone pain)
• People who still have side effects from previous treatments above a mild level (Grade 1), except for certain hormone-related immune side effects that are being managed with a stable dose of medication
• People who have taken an experimental drug within 28 days (or five half-lives, whichever is shorter, with a minimum of 14 days) before the first dose
• People who have used certain blood cell–stimulating medications (such as G-CSF or GM-CSF) within 14 days before starting treatment
• People with a known history of HIV infection
• People with an active hepatitis B or hepatitis C infection
• People currently taking systemic steroid medication or other immune-suppressing drugs (topical, eye, ear, joint, or inhaled steroids are generally acceptable)
• People with a history of a bleeding disorder
• Pregnant, likely to become pregnant, or breastfeeding women
• People with another serious uncontrolled illness, as assessed by their doctor
• People with a blocked bile duct, a bile duct stent, or prior bile duct surgery (other than gallbladder removal), or any physical differences in anatomy that could interfere with the liver-directed treatment used in the trial
• People with a blocked main portal vein (the large vein supplying the liver)
• People without adequate alternative blood flow around a blocked portal vein, as determined by imaging
• People found to have an abnormal connection between an artery and vein in the liver on imaging
• People with any medical condition that the investigator believes would make participation unsafe or would interfere with the study
• For Part 1 only: People with a history of a severe allergic reaction to the medication GM-CSF

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