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 who speak English
• People with a body mass index (BMI) between 18.5 and 45
• People whose cancer has not significantly limited their ability to carry out daily activities (this is measured using a standard scale called ECOG — confirm with trial site what score of 0 or 1 means for your situation)
• People who have been diagnosed with advanced (stage III or IV) melanoma that cannot be surgically removed, including certain types such as skin, eye, hand/foot, or mucosal melanoma. People with brain involvement that is not causing symptoms may also be eligible.
• People who are about to start a first-line standard treatment using immune checkpoint therapy (a type of cancer treatment that helps the immune system fight cancer) for melanoma that has spread. Having had certain treatments before, in an earlier preventive setting, may still be allowed.
• People who are able to return to MD Anderson Cancer Center for check-ups and scans (though the immune therapy itself may be received at a local clinic)
• People whose cancer can be measured on scans according to standard criteria (a small number of people without measurable disease may also be considered)
• Women who are able to become pregnant must 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 diet (with some adjustments based on personal food preferences)
• People who are willing to attend scheduled visits, have blood drawn, and provide stool samples

Who may not be able to join:

• People who have already received immune checkpoint therapy for melanoma that has spread
• People with a history of inflammatory bowel disease, removal of the entire colon, or weight-loss (bariatric) surgery
• People currently taking steroid medications above a certain daily dose (equivalent to more than 10 mg of prednisone per day)
• People whose doctor determines that the study diet is medically unsuitable for them
• People who follow major dietary restrictions, such as a vegan, ketogenic, or extended fasting diet, or who have relevant food allergies or coeliac disease
• People with insulin-dependent diabetes or a condition that requires 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 used intravenous antibiotics in the past month, or oral antibiotics in the past two weeks
• People who regularly take supplements containing prebiotics, fibre, or probiotics and 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 who have cognitive impairment

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