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 diagnosed with stage III or stage IV cancer (confirmed by a tissue test) that cannot be treated with surgery.
• People whose cancer has not responded to standard treatments, including PD-1 immunotherapy on its own, or whose cancer came back or spread within 6 months of completing a PD-1-based treatment plan.
• People who are reasonably active and able to care for themselves (as rated by a standard medical scale), with a life expectancy of more than 3 months.
• People who finished previous cancer treatments at least 4 weeks ago (or at least 6 weeks ago for certain chemotherapy types), and whose side effects from those treatments have mostly resolved.
• People who have at least one tumour that can be injected directly and measures at least 5 mm at its longest point.
• People with brain metastases that are not causing symptoms and have been stable for at least 3 months, confirmed by a brain scan, and who have not needed steroid medication for at least 4 weeks.
• People whose blood counts, kidney function, liver function, and clotting levels fall within the ranges required by the trial (confirm specific values with the trial site).
• Female participants and their partners who use effective contraception during treatment and for at least 3 months after treatment ends.
• People with a history of genital herpes who have been free of an outbreak for at least 3 months before joining.
• People who are willing to give written consent to participate and are expected to follow the trial requirements.

Who may not be able to join:

• People with serious ongoing health conditions such as severe heart disease, stroke-related disease, uncontrolled diabetes, uncontrolled high blood pressure, serious infections, active stomach or bowel ulcers, or certain immune system disorders such as rheumatoid arthritis or lupus.
• People who are expected to need major surgery during the 28-day period before starting the trial or during the trial itself.
• People who have an active infection or an unexplained fever above 38.5°C at the time of screening or before the first dose.
• People with a past or current immune deficiency condition.
• People whose tumour cannot accommodate the required injection volume of 1 ml.
• People who are pregnant or currently breastfeeding.
• People who have used another experimental therapy or antiviral treatment within the 4 weeks before starting this trial.
• People with a known allergy to herpes virus preparations or the ingredients used in the trial treatment.
• People who have had a uveal (eye) melanoma or another separate cancer diagnosis within the past 5 years.
• People with a history of tuberculosis, or who have tuberculosis at the time of screening.
• People with certain lung conditions, including pulmonary fibrosis, interstitial lung disease, or radiation-related lung damage (confirm specific conditions with the trial site).
• People with active autoimmune diseases, or a history of autoimmune disease that could return — with some possible exceptions for stable, well-controlled conditions such as type 1 diabetes, hypothyroidism, or skin conditions not requiring systemic treatment (confirm with the trial site).
• People who have needed corticosteroid medication above a certain dose, or other immune-suppressing medications, within the 14 days before starting the trial — with some exceptions for inhaled or topical steroids (confirm details with the trial site).
• People whom the trial investigators consider unsuitable for participation for any other reason.

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