Effect of Diet on the Immune System in Patients With Stage III-IV Melanoma Receiving Immunotherapy, DIET Study (DIET)

This is an interventional supportive care trial for Clinical Stage III Cutaneous Melanoma AJCC v8 Read More

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Body mass index (BMI) 18.5-40 kg/m^2
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. English-speaking
5. Self-reported willingness to exclusively eat the provided diets
6. Self-reported willingness to comply with scheduled visits, undergo venipuncture, and provide stool samples
7. Cohort-specific:

Unresectable:

i. Histologically confirmed unresectable stage III or stage IV melanoma ii. Currently receiving therapy with standard of care anti-PD1 immunotherapy. Initial induction with anti-CTLA4 and anti-PD1 is allowed iii. Stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as best response while on anti-PD1 >= 6 months for metastatic melanoma with plan to continue anti-PD1 iv. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version [v]1.1; i.e., defined as at least 1 lesion that can be accurately measured in at least 1 dimension [longest diameter to be recorded] with a minimum size of >= 10 mm by computerized tomography [CT] scan or caliper measurement on clinical exam)

1. Participants must have at least one lesion amenable to biopsy that has not been previously irradiated
2. Participants must be willing to undergo a newly-obtained core needle or incisional biopsy at baseline. Fine needle aspiration is not acceptable

Adjuvant:

i. Resected stage II-IV melanoma with planned initiation of adjuvant anti-PD1 +/- anti-CTLA4

Neoadjuvant:

i. Histologically confirmed stage III/IV melanoma with planned initiation of neoadjuvant anti-PD1 + anti-CTLA4

1. Participants must be willing to undergo a newly-obtained core needle or incisional biopsy at baseline. Fine needle aspiration is not acceptable.

Exclusion Criteria:

1. History of >= grade II colitis or diarrhea on immunotherapy or any ongoing colitis or diarrhea of any grade
2. Unresolved >= grade III immune-related adverse event on immunotherapy (other than endocrinopathy requiring hormone replacement)
3. History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted).
4. Medical contraindications to intervention diet as determined by the treating physician
5. Self-reported major dietary restrictions related to the intervention
6. Diagnosis of diabetes mellitus type I or type II that requires medical treatment or random glucose > 200 mg/dL
7. Antibiotic use within 21 days of planned start of equilibration diet (self-reported and/or noted by the treating physician)
8. Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
9. Regularly taking probiotics, fiber supplements, or any other medication or supplement that could affect study outcome as determined by the principal investigator and unable/unwilling to discontinue for the purpose of the study. These agents must be discontinued at least 14 days prior to start of diet
10. Currently consuming an average estimated daily fiber intake exceeding 20 grams based on the results of the preliminary dietary assessment; vegetarian or vegan
11. Current smoker or heavy drinker (defined as > 14 drinks per week) or current self reported illicit drug use
12. Uncontrolled concurrent illness or infection or psychiatric illness/social situations that would limit compliance with study requirements
13. Unable or unwilling to undergo study procedures
14. Plan for travel during the study that would preclude adherence to prescribed diets