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 who have been diagnosed with stage IIIB, IIIC, or IIID melanoma (using the AJCC 8th edition staging system) that has spread to nearby areas but can be completely removed by surgery.
• People who have at least one melanoma lesion in the skin, tissue just under the skin, or a lymph node that is large enough to be injected directly (at least 10mm, or about 1cm, in size — either one lesion or several smaller ones that together reach that size).
• People who have previously had treatment for their melanoma (such as surgery, radiation, immunotherapy, or targeted therapy), as long as at least 6 weeks have passed since that treatment ended and side effects have mostly resolved.
• Adults aged 18 or older.
• People who are generally well enough to carry out daily activities with little or no restriction (as measured by a standard medical performance scale).
• People whose life expectancy is estimated to be more than 24 months.
• People whose blood cell counts and organ function results (including white blood cells, haemoglobin, platelets, liver function, kidney function, and a marker called LDH) fall within the ranges required by the trial.
• People who have tested negative for HIV, hepatitis B, and hepatitis C (with specific additional blood tests required for hepatitis B in some cases).
• People whose side effects from any previous treatment have largely resolved before joining the trial.
• Women who could become pregnant must have a negative pregnancy test at screening and must use highly effective contraception from the start of the trial until three months after the last study treatment.
• Men whose partners could become pregnant must agree to use two forms of contraception at the same time, from screening until three months after the last study treatment.
• People who have read and signed an informed consent form confirming they understand the trial.
• People who are willing and able to attend all scheduled visits and follow the trial procedures.

Who may not be able to join:

• People whose melanoma started in the eye (uveal melanoma) or in a mucous membrane (mucosal melanoma).
• People whose melanoma has spread to distant parts of the body (distant metastases) at the time of screening.
• People who have had, or currently have, a different type of cancer — with some exceptions, such as certain skin cancers, early-stage bladder cancer, melanoma in situ as a second primary, or any cancer that was successfully cured 5 or more years ago.
• People who have an active infection currently being treated, or another serious illness that the trial doctor believes would put them at risk or interfere with the trial.
• People who have had a heart attack or serious angina (chest pain) within the past year.
• People with poorly controlled irregular heart rhythms, including atrial fibrillation.
• People with moderate to severe heart failure (above Grade II on the standard NYHA scale).
• People whose heart pumping function (LVEF) is 50% or below, or who have significant abnormalities found on a heart tracing (ECG) or heart scan (echocardiogram).
• People with uncontrolled high blood pressure.
• People with significant reduced blood flow to the limbs due to peripheral vascular disease (Grade IIb–IV).
• People with severe diabetic eye disease (severe diabetic retinopathy).
• People with an active autoimmune disease.
• People who have previously received an organ transplant or stem cell transplant.
• People who are still recovering from major surgery or significant injury within the 4 weeks before joining the trial.
• People with a known allergy to IL-2, TNF, other human proteins, or any ingredient in the study treatment.
• People who are currently breastfeeding.
• People who have received anti-cancer treatment (other than minor surgery) within 4 weeks before joining the trial.
• People who have received certain antibody-based biological therapies within 6 weeks before joining the trial.
• People who are due to receive growth factors or immune-modifying treatments within 7 days before joining the trial.
• People who regularly take corticosteroids or other immune-suppressing medications (these cases will be reviewed individually with the trial sponsor).
• People who have already been enrolled and randomised in this same trial before.
• People with any other condition that, in the trial doctor's judgement, could make it difficult to follow the trial requirements.

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