Phase 3 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 12 or older at the time of signing the consent form
• People who have been diagnosed with advanced skin melanoma (stage 3b through stage 4) that cannot be surgically removed or has spread, confirmed by laboratory testing of tissue samples
• People whose melanoma continued to grow or spread after receiving both an anti-PD-1 treatment and an anti-CTLA-4 treatment, either given together or one after the other, with the disease progression confirmed by at least two assessments at least 4 weeks apart
• People who were unable to receive anti-CTLA-4 treatment due to other health conditions or serious side effects from immune therapy, but whose disease progressed on anti-PD-1 treatment alone
• People who have had their BRAF gene mutation status tested, or who agree to have it tested during the screening period; those with a BRAF mutation should generally have already received BRAF-targeted treatment unless their doctor determined it was not appropriate
• People who have at least one measurable tumour of 1 cm or more, and at least one tumour that can be injected directly
• People whose blood counts and blood cell function are within an acceptable range as determined by required lab tests (confirm with trial site)
• People whose liver function test results are within an acceptable range as determined by required lab tests (confirm with trial site)
• People whose kidney function is within an acceptable range as determined by required lab tests (confirm with trial site)
• People whose blood clotting test results are within an acceptable range; those on blood thinners may still be considered depending on their levels (confirm with trial site)
• People who are generally able to carry out daily activities with no or minimal limitations — rated on a standard scale — which applies differently for adults versus those aged 12 to 17 (confirm with trial site)
• People with a life expectancy of at least 3 months
• People who are able to use highly effective contraception during treatment and for at least 6 months after the last dose, if there is any possibility of becoming pregnant or causing a pregnancy
• Women who could potentially become pregnant must have a negative pregnancy blood test within 7 days before the first dose
• People who are willing and able to give informed consent and follow the study requirements

Who may not be able to join:

• People whose melanoma started in the mucous membranes (such as inside the nose or mouth) or in the eye (uveal melanoma)
• People who have already received more than 2 lines of systemic treatment for advanced melanoma
• People with active hepatitis B or hepatitis C infection that has not been successfully treated
• People with a known HIV infection
• People with active or significant herpes infections, a history of serious herpes complications (such as herpes affecting the eyes or brain), or who regularly need antiviral medicines that target the herpes virus
• People who have had a serious infection requiring intravenous antibiotics or other intensive antimicrobial treatment within 14 days before the first dose
• People with spinal cord compression or who are at high risk of developing it
• People with active brain metastases, unless the brain metastases have been treated and shown to be stable on two scans at least 4 weeks apart
• People with a blood marker called LDH that is more than twice the upper limit of normal (confirm with trial site)
• People who have had major surgery within 2 weeks before starting the study treatment
• People with another active cancer diagnosed within the last 3 years, except for certain easily treated skin cancers or very early-stage cancers that appear to have been fully removed
• People with a significant heart condition, including severe heart failure, unstable chest pain, serious heart rhythm problems, stroke, or heart attack within 6 months before the first dose
• People who have had a life-threatening reaction to a previous immune therapy, unless that reaction is very unlikely to happen again with standard management
• People with a significant psychiatric condition, substance use disorder (including use of injected substances), or other serious medical or psychological condition that the investigator considers would affect safety or study participation
• People with any other condition or circumstance that the treating doctor believes would interfere with participation or would not be in the person's best interest
• People with an active autoimmune disease currently requiring systemic treatment
• People with a history of non-infectious lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People who have previously received an oncolytic virus therapy or any treatment given by direct injection into a tumour
• People who regularly need antiviral medicines that target the herpes virus
• People who have received a live vaccine within 28 days before the first dose
• People who have received systemic anti-cancer treatment within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before the first dose
• People currently participating in, or who have participated in, another clinical trial of an investigational treatment within 4 weeks before the first dose
• People who have had radiotherapy within 2 weeks before starting the study, or who have not yet recovered from radiotherapy
• People who require high-dose steroid medicines (more than 10 mg of prednisone per day or equivalent) for conditions other than hormone replacement, within 14 days before joining the study
• People with a known allergy or sensitivity to any of the study drugs or related medicines used in the trial
• People who have used herbal supplements, traditional medicines, or botanical health preparations within 2 weeks before starting treatment
• People who are detained, hospitalised involuntarily, or in an emergency situation at the time of enrolment

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