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 been diagnosed (confirmed by lab testing) with metastatic or inoperable skin melanoma, non-small cell lung cancer (NSCLC), or cervical cancer that has grown or spread after at least one standard cancer treatment, or where standard treatment is not an option.
• People who have at least one tumour or metastasis that can be safely removed or biopsied (preferably using a minimally invasive, image-guided procedure) to grow specialised immune cells called TILs in a laboratory.
• People who still have at least one other measurable area of disease remaining after the tumour removal or biopsy used to make the TIL treatment.
• People who are at least 18 years old at the time of the tissue collection visit.
• People who are able to understand and sign a consent form before any study procedures begin.
• People who are able and willing to attend all required study visits and follow the study requirements.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People whose blood counts, kidney function, and liver function meet specific minimum levels set by the trial — the trial site will check these through blood tests.
• People whose heart is pumping at least 45% of its normal capacity, confirmed by a scan.
• People whose lungs are functioning at 50% or more of expected levels, confirmed by breathing tests.
• People who test negative for HIV antibodies.
• People who test negative for active Hepatitis B and Hepatitis C (certain past infections with cleared virus may still be eligible — confirm with trial site).
• People with a life expectancy of at least 3 months.
• People of childbearing potential, or those with a partner of childbearing potential, who agree to use a highly effective method of contraception during the study and for at least 6 months after the last dose of a drug called IL-2.
• Female participants who are not pregnant and not breastfeeding, and who either cannot become pregnant or agree to use contraception with a failure rate of less than 1% per year, have a negative blood pregnancy test within one week before starting treatment, and agree not to donate eggs during the study.
• Male participants who agree to use contraception or remain abstinent during treatment and for at least 2 months after the last dose, agree not to donate sperm, and agree to notify the trial team if their partner becomes pregnant.
• People whose side effects from previous cancer treatments have largely resolved (to a mild level or better) at least 4 weeks before joining, with some exceptions allowed (such as hair loss, certain nerve-related symptoms, or hormone conditions being managed with medication).
• People who have had a minor surgical procedure within the past 3 weeks, as long as any related side effects have resolved to a mild level or better.

Who may not be able to join:

• People with more than two areas of cancer spread to the brain; those with brain metastases larger than 1 cm or with swelling around them must have completed definitive treatment and been stable for at least 4 weeks, and must not need more than a low dose of steroid medication.
• People who are experiencing symptoms caused by brain metastases.
• People whose cancer has spread to the lining around the brain and spinal cord (leptomeningeal carcinomatosis).
• People who have had another invasive cancer in the past 3 years, with some exceptions (such as certain early-stage or skin cancers — confirm with trial site).
• People with an active infection requiring treatment within 14 days before the preparatory chemotherapy phase of the trial.
• People with active Hepatitis B or Hepatitis C infection.
• People with an active autoimmune disease that requires immune-suppressing medication.
• People who have had an organ or bone marrow transplant.
• People with a primary immune deficiency condition (such as Severe Combined Immunodeficiency or AIDS).
• People who regularly need steroid medication at doses higher than the equivalent of 10 mg of prednisone per day (inhaled or topical steroids and low-level replacement therapy are generally permitted — confirm with trial site).
• People with a significant, ongoing, or uncontrolled disease affecting the kidneys, liver, blood, hormones, lungs, heart, digestive system, or nervous system within the past 6 months.
• People who have had a heart procedure to open blocked arteries, or who have had heart-related symptoms, within 6 months of the first chemotherapy dose in the trial.
• People with a history of idiopathic pulmonary fibrosis (a type of lung scarring) or current active lung inflammation.
• People with a known allergy to any of the medications or substances used in this trial.
• People with medical reasons that prevent them from receiving the specific chemotherapy drugs (cyclophosphamide, fludarabine) or IL-2 used in this trial.
• People who have received cancer treatments — including chemotherapy, anti-angiogenic therapy, immunotherapy, or radiotherapy — within 4 weeks before the preparatory chemotherapy phase (with some limited exceptions such as palliative bone radiation — confirm with trial site).
• People who have received certain targeted therapy or non-chemotherapy cancer drugs within 4 weeks (or within five half-lives of the drug, whichever is shorter) before the preparatory chemotherapy phase.
• People who have taken part in another clinical trial and received an experimental drug within 4 weeks (or within five half-lives, whichever is shorter) before the preparatory chemotherapy phase.
• People who have received a live or weakened live vaccine within 4 weeks before the preparatory chemotherapy phase.
• People who have undergone major surgery within 3 weeks before the preparatory chemotherapy phase.
• People who have previously received any experimental cell or gene therapy.
• Women who are pregnant or breastfeeding.
• People with psychological, personal, social, or geographical circumstances that may make it difficult to follow the study schedule and requirements.

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