Early Phase 1 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:

• Adults aged 18 or older.
• People who have been diagnosed with advanced melanoma and are planned to have surgery to remove the tumour.
• People whose tumour(s) can be seen clearly on an ultrasound scan, measure at least 1 cm across, sit between 5 mm and 23 mm below the skin surface, and are safely away from bones, major blood vessels, nerves, and vital organs (brain lesions cannot be targeted).
• People whose tumour is suitable for a direct injection into it, as determined by the treating doctor.
• People who are currently receiving immunotherapy (checkpoint blockade treatment), either as a single drug or a combination.
• People whose tumour has been previously treated with radiation may still be considered, provided the tumour has since grown back and a biopsy has been taken after that regrowth and before joining the study.
• People who are generally well enough to carry out daily activities (confirm with trial site — this refers to a standard medical fitness scale scored 0–2).
• People with known spread of melanoma to the brain may still be considered, provided: no brain tumour has grown since the last brain treatment, no single brain tumour is larger than 2 cm, any neurological symptoms have returned to their usual baseline, there is no sign of new or growing brain tumours, and the person has not been taking steroid medications for at least 7 days before joining (or for at least 7 days after finishing a steroid course used to manage brain tumours).
• People who are willing and able to give their informed consent to participate.

Who may not be able to join:

• People who have received any of the following within the 4 weeks before the study start date: standard radiation therapy, allergy desensitisation injections, high-dose steroid medications (low-dose oral or inhaled steroids may be allowed in certain circumstances — confirm with trial site), growth factor medications, interleukin treatments, any other experimental treatment, targeted therapies for BRAF or MEK gene mutations, live vaccines, interferon treatments, or cancer chemotherapy. Note: certain types of precision radiotherapy (such as gamma knife) may be allowed if given at least 1 week before registration (confirm with trial site).
• People with a known addiction to alcohol or drugs who are currently using those substances, have used them within the past year, or who currently use drugs intravenously.
• People known to be HIV positive, or who have active Hepatitis B or C infection — unless HIV is being managed with antiretroviral therapy throughout the study, or unless Hepatitis B or C is present but no virus can be detected in the blood.
• People who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test within 2 weeks before joining. All participants must agree to use effective contraception during and after treatment, in line with the guidelines for each therapy used.
• People who have a medical condition or other issue that, in the opinion of the study doctor, would prevent them from safely following the study requirements.
• People who have an active infection currently being treated with systemic (whole-body) medications.
• People with serious heart disease classified as Class III or IV (confirm with trial site).
• People who have received the study injection drug (polyICLC) within the past 4 weeks. Additionally, if a person previously received this drug directly into a tumour and had a severe reaction to it, that same tumour site cannot be treated again in this study.

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