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 or older
• People with a body mass index (BMI) between 18.5 and 45 (a measure of body weight relative to height)
• People who are able to complete study questionnaires tracking their diet and digestive symptoms on their own
• People with a good to fully active level of physical functioning (confirm with trial site what this means for a specific situation)
• People who have been diagnosed with a specific type and stage of skin melanoma (stage IIIB–D that can be surgically removed, or a limited spread of stage IV), or with melanoma affecting the mucous membranes (such as inside the mouth or nose), confirmed by a specialist team
• People who are planned to start a standard treatment course using specific immunotherapy drugs (ipilimumab with or without nivolumab, or nivolumab with or without relatlimab) before surgery
• People whose cancer can be measured using standard imaging criteria (confirm with trial site)
• Women of childbearing potential who have a negative pregnancy test within one week of starting the dietary part of the study
• People who are willing to eat the foods provided as part of the study (with some adjustments for personal food preferences)
• People who are willing to attend scheduled visits, have blood drawn, and provide stool samples
• People who have an existing tumour tissue sample available, or who are already planned to have a tumour biopsy as part of their standard treatment

Who may not be able to join:

• People with a type of eye melanoma called uveal melanoma
• People with a history of inflammatory bowel disease, removal of the entire large bowel, or weight-loss surgery on the stomach or bowel
• People currently taking steroid medication at a dose higher than the equivalent of 10 mg per day of prednisone
• People whose doctor determines the study diet is medically unsuitable for them
• People with major dietary restrictions, including significant food allergies, coeliac disease, or who follow a vegan, ketogenic, or extended fasting diet
• People with insulin-dependent diabetes, or who require a specific type of medication called bile-acid sequestrants
• People who are unable or unwilling to take part in the study procedures
• People who have received intravenous (IV) antibiotics more than once in the past month, or any antibiotic (IV or by mouth) in the past two weeks
• People who regularly take supplements containing prebiotics, fibre, or probiotics and who are unwilling or unable to stop taking them for the study
• People who currently smoke, drink more than 14 alcoholic drinks per week, or use illicit drugs
• People who are currently pregnant, planning to become pregnant, or breastfeeding
• People who have another cancer that requires systemic treatment (other than hormonal therapy)
• People with cognitive impairment

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