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 who have signed the consent form and are able to follow the study schedule and requirements
• People aged 18 to 75 years, of any gender
• People diagnosed with advanced, returning, or spreading melanoma that cannot be surgically removed (uveal melanoma, a type that starts in the eye, is not included)
• People whose cancer has stopped responding to or has gotten worse on PD-1 antibody treatment (a type of immunotherapy)
• People whose cancer has stopped responding to or progressed after at least two prior systemic (whole-body) treatments — if a BRAF V600 gene mutation is known, prior treatment with BRAF/MEK inhibitors is also required; if an NRAS gene mutation is known, prior treatment with Tunlametinib is also required
• People who have a tumor that can be surgically removed to collect immune cells called TILs, where the tissue is larger than 150mm³ and has either not received local treatment or has progressed after local treatment, and where at least one other measurable tumor remains after that tissue is removed
• People with a general health performance score of 0 or 1 on the ECOG scale (meaning fully active or restricted in strenuous activity but able to carry out light work)
• People with an expected survival of more than 3 months
• People with adequate blood counts and organ function
• People who are willing and able to attend study visits and follow study requirements

Who may not be able to join:

• People who have taken part in another clinical drug study within the 28 days before screening
• People with two or more active cancers, except: cancers that have been fully treated and have been inactive for 5 or more years with very low chance of returning; adequately treated non-melanoma skin cancers with no sign of return; or adequately treated early-stage cancers (carcinoma in situ) with no sign of return
• People who have received a live attenuated vaccine (such as certain flu or travel vaccines) after signing the consent form, or who are scheduled to receive one during the study
• People who have not yet recovered from side effects of a previous treatment or procedure to a mild level or below (with some exceptions such as hair loss or low thyroid, which the study doctor may decide pose no safety risk)
• People with a known allergy to streptomycin, ciprofloxacin, or micafungin, or to any ingredient in the treatment being given in this trial
• People with uncontrolled high blood pressure, unstable heart conditions, recent stroke or heart attack (within 6 months), severe heart failure, serious heart rhythm problems, or abnormal heart electrical readings on an ECG
• People with serious varicose veins in the throat or stomach area that need urgent treatment, signs of high pressure in the liver's blood vessels, or a history of bleeding from such veins (unless a specific scope examination has been done within 3 months before joining)
• People with uncontrolled conditions such as poorly controlled diabetes or other serious non-cancer organ or body system diseases that could increase medical risk
• People with serious liver conditions including liver-related brain problems (hepatic encephalopathy), kidney failure caused by liver disease, moderate-to-severe cirrhosis, or liver failure
• People with other serious organ diseases or mental health disorders
• People with an active, ongoing infection that requires treatment, including active tuberculosis
• People with infectious diseases including hepatitis B, hepatitis C, syphilis, or HIV/AIDS
• People with active autoimmune diseases (though some milder conditions — such as vitiligo, psoriasis not requiring systemic treatment, hypothyroidism managed with thyroid hormone only, or type 1 diabetes managed with insulin only — may still be eligible; confirm with trial site)
• People who had a severe (grade 3 or higher) immune-related side effect during any previous immunotherapy, unless it fully resolved or stabilised with treatment
• People who have previously had an organ transplant, bone marrow or stem cell transplant from a donor, or are on dialysis
• People with pulmonary fibrosis, interstitial lung disease (past or present), or acute lung disease
• People whose cancer has spread to the lining around the brain or spinal cord (leptomeningeal metastasis)
• People with active or worsening brain metastases causing symptoms (such as brain swelling or needing steroids); people who have previously been treated for brain metastases may be eligible if their condition has been stable on MRI for at least 2 months and they have stopped taking steroid medications above a certain dose for more than 4 weeks (confirm with trial site)
• People who are pregnant or breastfeeding
• People who have received TIL cell therapy, donor T cell therapy, or NK cell therapy within the past 6 months
• People whom the study doctor considers unsuitable for any other reason

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