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:

• People aged 18 or older at the time of signing the consent form.
• People with a laboratory-confirmed diagnosis of stage III or stage IV (M1a) melanoma that a specialist team has agreed can be fully removed by surgery and is suitable for treatment before surgery.
• People whose melanoma originated in the skin (including the hands or feet) or in mucous membranes (including the eye's surface tissue called the conjunctiva).
• People whose melanoma can be measured and seen on scans or physical examination, according to standard measurement guidelines (RECIST v1.1).
• People who the surgical team considers healthy enough to undergo the planned surgery.
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (ECOG score of 0 or 1).
• People who have at least one accessible skin, under-skin, or lymph node tumour that can be injected, measuring no more than 3.0 cm across on average.
• People willing to have an additional tumour biopsy and allow tissue samples to be used for the study.
• People whose blood test results show the body's organs are functioning adequately, including acceptable levels of red blood cells, white blood cells, platelets, liver function markers, kidney function, and protein levels.
• Female participants who are willing to use contraception as outlined in the study protocol from the first visit until 120 days after the last study treatment, and who test negative for pregnancy within 72 hours before the first treatment.
• People who are able to give informed consent and follow the requirements of the study.

Who may not be able to join:

• People whose melanoma started in the uveal tract (the inner layer of the eye).
• People with a history of melanoma that has spread to the brain, bones, liver, or the lining around the brain and spinal cord.
• People with stage IV melanoma that has spread to four or more separate sites in the body.
• People with any condition, ongoing treatment, or abnormal test result that, in the treating doctor's opinion, could interfere with the study results or with participation for the full duration of the trial.
• People with an active autoimmune disease that requires ongoing medication to suppress or modify the immune system (note: standard hormone replacement therapies such as low-dose steroids, insulin, or thyroid medication are permitted).
• People with a history of, or current signs of, lung inflammation (interstitial lung disease or non-infectious pneumonitis) that required steroid treatment.
• People with a previous or current cancer that needs treatment at the same time as this trial.
• People with a known allergy or sensitivity to pembrolizumab, LTX-315, or any ingredients in these treatments, or to any required preventive medications used in the study.
• People who have previously received cancer immunotherapy, including treatments that target CTLA-4 or PD-1 (confirm with trial site for specific examples). Prior non-immunotherapy treatments such as targeted therapy or radiotherapy, or regional procedures such as electrochemotherapy or isolated limb perfusion, may be permitted if completed at least 12 weeks before enrolment.
• People currently taking immune-suppressing medications, or who have taken steroid tablets at doses of 10 mg of prednisolone (or equivalent) or higher within the past 28 days (topical and inhaled steroids are permitted).
• People who have received a live vaccine within 30 days before the first dose of study treatment.
• People who have received another experimental drug within 4 weeks before the start of the study, or who are scheduled to receive one during the study period.
• People who are pregnant or breastfeeding.
• People whom the investigator considers unsuitable for participation for any other reason.

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