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 a confirmed diagnosis of metastatic uveal melanoma (Cohort 1), regardless of how many previous treatments they have had.
• People who have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that has stopped responding to at least one previous systemic treatment, or who have declined standard chemotherapy (Cohort 2).
• People who have at least one tumour measuring 1.5 cm or larger that is available for a tissue harvesting procedure, and has not had a blood vessel blocking procedure or radiation in the past 3 months (unless the tumour has since grown by at least 0.5 cm).
• People who are 18 years of age or older at the time of giving consent.
• People who are generally well enough to carry out light activity or be fully active, as measured by a standard medical scoring tool called the ECOG scale (score of 0 or 1).
• People who are expected to live for at least 6 months, in the opinion of the trial doctor.
• People whose blood counts fall within certain required ranges — including white blood cells, red blood cells, and platelets — without having needed a transfusion or growth factor treatment in the 28 days before signing the consent form.
• People whose liver, kidney, and bilirubin levels fall within the ranges required by the trial (confirm specific values with the trial site).
• People who test negative for HIV, hepatitis B, hepatitis C, syphilis, cytomegalovirus (CMV), Epstein-Barr virus (EBV), and herpes simplex virus (HSV) — or, in some cases, who have had these infections treated to undetectable or non-active levels before starting treatment.
• People who have had COVID-19 previously but have been without symptoms for more than 30 days before the pre-treatment chemotherapy phase.
• People who have completed a required waiting period after their last cancer treatment before starting this trial (the length varies depending on the type of treatment received — confirm specifics with the trial site).
• People who have recovered from side effects of previous cancer treatments to a mild or resolved level, with the exception of hair loss or skin colour changes, which are permitted.
• People with previous bowel inflammation caused by immunotherapy who have had no symptoms for at least 6 months and/or had a normal colonoscopy after that treatment.
• People with hormone-related side effects from previous immunotherapy (such as an underactive thyroid) that have been stable for at least 6 weeks and are managed with hormone replacement.
• People who have had previous surgery, provided that wounds have healed, complications have resolved, and at least 14 days have passed before the tumour removal procedure.
• People who are able to become pregnant, or whose female partners could become pregnant, and who are willing to use a highly effective form of contraception during the study and for 12 months after the last dose of IL-2 (approved methods are listed and can be confirmed with the trial site).
• People who are able to understand the study requirements and provide written consent.

Who may not be able to join:

• People who have previously received an organ transplant or a cell therapy treatment that involved chemotherapy to suppress the immune system.
• People who have had a severe allergic reaction to any of the study drugs or their ingredients, including the pre-treatment chemotherapy medicines, IL-2, certain antibiotics, or components of the cell therapy product.
• People who currently have brain metastases causing symptoms (though people with brain metastases that have been fully treated and have been clinically stable for at least 14 days, with no ongoing steroid treatment, may be considered — confirm with the trial site).
• People who are currently taking long-term immune-suppressing medicines, except those taking low-dose steroids (no more than 10 mg of prednisone daily) for adrenal gland problems.
• People who are pregnant or breastfeeding.
• People who have serious active medical conditions that could increase the risks of taking part, such as active infections requiring antibiotics, blood clotting disorders, or major problems with the heart, lungs, or immune system.
• People who have received a live or weakened (attenuated) vaccine within 28 days before the pre-treatment chemotherapy phase begins.
• People who have a primary immune deficiency condition, such as severe combined immunodeficiency (SCID) or AIDS.
• People whose heart is not pumping strongly enough (below a set threshold), or who have been classified as having more than minimal heart failure symptoms, based on standard heart function tests.
• People aged 60 or older with a history of heart disease, chest pain, or significant heart rhythm problems who do not pass a cardiac stress test, or who have permanent abnormalities in heart wall movement.
• People with a history of smoking or breathing problems whose lung function test result falls at or below 60% of the expected normal level (a walking test may be used if a standard breathing test cannot be completed; people unable to walk the required distance or who show low oxygen levels during the test are not eligible).
• People who have an active, uncontrolled infection including COVID-19 within 30 days before surgery or the pre-treatment chemotherapy phase.
• People who have taken part in another clinical trial using an investigational treatment within 21 days before the pre-treatment chemotherapy phase begins.
• People who have another active cancer that requires ongoing systemic treatment or makes it difficult to assess how the trial treatment is working (some exceptions may apply — confirm with the trial site).

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