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 are 18 years of age or older at the time of signing the consent form
• People who have a confirmed diagnosis of advanced or metastatic melanoma, or metastatic non-small cell lung cancer (NSCLC) that has returned or stopped responding to treatment
• People with melanoma (in certain study groups) whose disease continued to grow after receiving a type of immunotherapy that targets the PD-1 or PD-L1 pathway, and who have received no more than 2 prior systemic treatments
• People with non-small cell lung cancer (in certain study groups) whose cancer has returned or stopped responding to approved treatments, including immunotherapy and any approved targeted therapy relevant to their cancer type, and who have not received a second round of chemotherapy if they already received chemotherapy as their first treatment
• People with melanoma (in one specific group) who have a particular gene mutation called BRAF, where prior BRAF-targeted therapy is not required, but whose most recent treatment must not have been a BRAF/MEK inhibitor that stopped working
• People with newly diagnosed unresectable or metastatic melanoma (in one specific group) who may have received up to 2 doses of PD-1/PD-L1 immunotherapy without known disease progression
• People who have at least one tumour site suitable for use in generating the study treatment
• People who have at least one measurable tumour remaining after the tumour tissue is removed for treatment preparation
• People who are assessed as reasonably well and active, with a performance status score of 0 or 1 on a standard medical scale, and an expected survival of more than 6 months
• People who have recovered from side effects of prior cancer treatments to a mild level or better before joining
• People who have fully recovered from any prior surgery, including wound healing, before the planned tumour removal procedure
• People who agree to follow the contraception or abstinence requirements specified in the trial protocol
• People who meet specific blood count requirements for white blood cells and platelets as defined in the protocol
• People who have adequate heart, liver, lung, and kidney function as defined in the protocol

Who may not be able to join:

• People whose melanoma originated in the eye (uveal melanoma) or has certain related genetic mutations (such as GNA11 or GNAQ)
• People with a history of cancer that has spread to the brain or the lining of the brain and spinal cord, unless they have 4 or fewer treated brain tumours and meet additional criteria as assessed by the medical team (confirm with trial site)
• People with an active medical condition that the treating doctor believes would make participation too risky
• People with non-small cell lung cancer who have fluid around the lungs that is not responding to treatment and is causing significant symptoms
• People with any form of immune system deficiency, whether present from birth or developed over time
• People who have had an allergic reaction to any ingredient in the study treatment
• People who have had another separate cancer within the past 3 years, with some exceptions as outlined in the protocol (confirm with trial site)
• People who have previously received an organ transplant from another person, a cell therapy from another person, or a genetically engineered cell therapy (note: prior engineered tumour-infiltrating lymphocyte cell therapy is permitted)
• People who require ongoing steroid treatment at a dose greater than 10 mg per day of prednisone or an equivalent steroid
• People who have received a live or weakened live vaccine within 28 days before the start of the pre-treatment immune-clearing phase of the study
• People who test positive for certain infectious diseases during screening, or who have an active uncontrolled infection (viral, bacterial, or fungal) requiring ongoing treatment

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