Phase 1 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 melanoma that cannot be surgically removed or has spread to other parts of the body (stage IIIc or stage IV), confirmed by a tissue biopsy.
• People whose melanoma has continued to grow or spread after receiving standard immunotherapy treatments targeting PD-1, either alone or combined with a CTLA-4 blocker.
• People aged 18 to 75 years at the time of signing the consent form.
• People who are in good general health and able to carry out daily activities with little or no limitation, as assessed by a standard medical scale (ECOG score of 0 or 1).
• People who are well enough to undergo surgery, and who have at least one tumour larger than 1 cm³ that can be surgically removed to create the personalised immune cell treatment.
• People who have at least one other tumour that can be measured using standard imaging methods (separate from the one to be surgically removed).
• People whose heart is pumping blood effectively, with a heart function score of at least 50% as measured by a heart scan or ultrasound.
• People whose blood counts, kidney function, liver function, and blood clotting results meet the specific levels required by the trial (confirm with trial site for exact values).
• People who have given written and verbal agreement to take part after being fully informed about the study.
• People who are willing and able to attend all required follow-up appointments and to manage any side effects that may arise.
• People whose next planned treatment after tumour removal will be the T-cell therapy used in this trial (a short bridging treatment may be permitted in some circumstances if the trial doctor considers it necessary while the personalised treatment is being made — confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test before starting treatment and must agree to use an effective form of contraception for at least 12 months from the first dose of chemotherapy, and must agree not to donate or store eggs during this time.
• Men must agree to use effective contraception or abstain from sexual activity with a woman who could become pregnant, starting from the first dose of chemotherapy and for 6 months afterwards, and must agree not to donate or store sperm during this time.

Who may not be able to join:

• People who have received certain treatments too recently before the tumour removal surgery or the chemotherapy preparation phase — including standard chemotherapy (within 3 weeks), targeted therapy drugs (within 1 week), immunotherapy such as checkpoint inhibitors (within 2 weeks), experimental treatments (within 4 weeks or 5 half-lives, whichever is shorter), high-dose steroids or other immune-suppressing drugs (within 2 weeks), radiation to the pelvis or large areas of bone (within 4 weeks), brain radiation (within 4 weeks), or radiation to the tumours being measured in the trial (within 3 months of receiving the T-cell infusion).
• People who have previously received T-cell therapy or gene therapy using a certain type of vector.
• People who have had another type of cancer in the past, unless they have shown no signs of that cancer for at least 2 years after completing treatment (some exceptions apply for certain low-risk skin cancers and breast conditions — confirm with trial site).
• People whose melanoma originated in the eye, mucous membranes, or other non-skin areas (melanoma of unknown primary origin may still be eligible — confirm with trial site).
• People who still have significant side effects from previous cancer treatments that have not settled back to a mild level or to their pre-treatment baseline (some stable or permanent mild side effects such as nerve damage may be acceptable — confirm with trial site).
• People who have more than 2 brain metastases, or any brain lesion that is causing symptoms, is larger than 1 cm, or shows significant swelling on an MRI scan — unless they have been treated and shown no sign of brain progression for at least 2 months.
• People with a history of heart bypass or stent procedures, significant heart rhythm problems (such as atrial fibrillation or certain heart blocks), or significantly reduced lung function (particularly those with a long history of heavy smoking, large tumours in the lungs, or breathing difficulties).
• People who have a known allergy to any of the medications used in this trial.
• People with serious medical conditions such as severe asthma or chronic lung disease, significant heart disease, or poorly controlled insulin-dependent diabetes.
• People with active or ongoing infections such as HIV, hepatitis, or syphilis.
• People with a history of severe allergic reactions or anaphylaxis.
• People with an active autoimmune or immune-related disease that has not resolved (some stable, well-controlled immune conditions may be acceptable — confirm with trial site).
• Women who are pregnant or breastfeeding.
• People who, in the opinion of the trial doctor, are unlikely to be able to follow the full requirements of the trial.

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