Phase 2 Melanoma Trial, Recruiting

Written by an AI model from the 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 years or older
• People who have been diagnosed with advanced skin melanoma (stage III or IV) that has been confirmed by a tissue sample and requires treatment with an anti-PD-1 medication (a type of immunotherapy)
• For stage IV disease, only people with a specific level of spread (classified as M1a or M1b — confirm with trial site for what this means in your situation) are considered
• People whose melanoma has grown by 20% or more on two scans taken four weeks apart while already on anti-PD-1 treatment, with the second scan done within three weeks before signing the trial consent form
• People who have measurable areas of disease that can be tracked on scans
• People who are generally well enough to carry out normal daily activities with little or no limitation (a medical fitness score of 0 or 1 on a standard scale)
• People with a life expectancy of more than three months
• People whose liver, kidneys, and other organs are working well enough, based on standard blood tests taken before treatment
• People with a normal LDH level (a marker measured in a blood test)
• People of any gender who are willing to use a highly effective form of contraception during the trial
• People who are able to understand and sign the official consent form for the trial

Who may not be able to join:

• People with certain types of melanoma — specifically acral (on palms or soles), uveal (in the eye), or mucosal (on inner body surfaces) melanoma, or cases where the original source of the melanoma is unknown
• People who have received any melanoma treatment other than anti-PD-1 therapy
• Stage IV patients whose disease has spread to a more advanced level (classified as M1c or M1d)
• People with certain autoimmune conditions, particularly inflammatory bowel disease such as ulcerative colitis or Crohn's disease (some autoimmune conditions such as Hashimoto's thyroiditis, vitiligo, or past psoriasis without current active disease may still be considered — confirm with trial site)
• People who are still taking immunosuppressant medications to manage serious (grade 3 or 4) immune-related side effects from previous immunotherapy (people whose serious immune side effects have eased significantly and who have been off immunosuppressants for at least two weeks may still be considered — confirm with trial site)
• People who have melanoma that has spread to the brain or the lining around the brain or spinal cord
• People with an elevated LDH blood level
• People who have had major surgery on the stomach, oesophagus, or bowel (such as a Whipple procedure or removal of a large portion of the colon)
• People with a severe food allergy (for example, to nuts or shellfish)
• People who have difficulty swallowing or are expected to have problems with bowel passage (such as bowel blockage, fistulas, or perforation)
• People who are unable to swallow approximately two litres of a bowel-cleansing liquid
• People with a life expectancy of less than three months
• People with serious heart or lung conditions, as assessed by the trial doctor
• People who are pregnant or breastfeeding
• People with active infections throughout the body, blood clotting disorders, or other serious ongoing medical conditions
• People with another current or recent cancer, unless it has been successfully treated and is not expected to affect life expectancy for more than five years
• People who have taken antibiotics in the three months before joining the trial, or who are expected to need antibiotic treatment during the trial

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