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 aged 18 to 75 years old, either male or female, at the time of signing the consent form
• People whose doctors expect them to survive for more than 3 months
• People who are relatively active and able to care for themselves (a medical scoring system called ECOG rates this as 0 or 1 — confirm with trial site)
• People with melanoma (not including eye melanoma) that cannot be surgically removed and has come back or spread to other parts of the body, and whose cancer has not responded to at least two standard treatments
• People whose cancer did not respond to, or who could not tolerate, a type of immunotherapy drug called a PD-1 antibody
• People whose tumour has a specific gene change called BRAF V600 mutation, who also did not respond to targeted treatments for that mutation
• People whose tumour has a specific gene change called NRAS mutation, who also did not respond to a specific targeted treatment (Tunlametinib)
• People who have at least one tumour that can be surgically removed or biopsied
• People who still have at least one other measurable tumour remaining after the biopsy or removal procedure
• People whose blood counts and organ functions (such as liver and kidneys) are at adequate levels
• People who are willing to sign a written consent form agreeing to take part

Who may not be able to join:

• People who have had another cancer (other than melanoma) in the past 5 years, unless it was a type considered fully treated and cured, such as certain thyroid cancers, early-stage cervical cancer, certain skin cancers, or early breast cancer treated with surgery
• People who still have side effects from previous cancer treatments that have not settled down to a mild level (with some specific exceptions — confirm with trial site)
• People who had a severe immune-related side effect (grade 3 or higher) from a previous immunotherapy treatment that caused that treatment to be permanently stopped
• People who have received a vaccine within two months before the tumour removal surgery, or who plan to receive a vaccine during the study
• People who have received certain types of cell-based therapies (TIL, allogeneic T cell, or NK cell therapy) within the 6 months before signing the consent form
• People who have previously had a bone marrow transplant or an organ transplant
• People who have cancer that has spread to the brain or the lining around the brain, unless the brain metastases were treated and have been stable for at least 6 months with no signs of new growth
• People who currently have or are suspected of having an active autoimmune disease (where the immune system attacks the body)
• People with a significant build-up of fluid around the lungs or in the abdomen that is causing symptoms or needs treatment
• People with current or past permanent scarring or damage to the lungs (irreversible interstitial lung disease)
• People with serious heart or blood vessel conditions
• People with an active infection currently requiring treatment with medication
• People with infectious diseases including hepatitis B, hepatitis C, syphilis, or HIV/AIDS
• People with certain serious conditions affecting veins in the oesophagus or stomach that may require urgent treatment or carry a high bleeding risk (confirm specific requirements with trial site)
• People with uncontrolled conditions such as diabetes, or other serious non-cancer illnesses that could affect safety or make it harder to assess results
• People known to be allergic to any ingredient in the trial drug or the LM103 product
• People who are pregnant or breastfeeding
• People who, in their doctor's judgement, have other serious medical conditions, mental health conditions, or abnormal test results that could affect safety or the reliability of the study results

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