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

Study Purpose

This phase II trial investigates the possible immune effects of two different diets targeting the gut microbiome in patients with stage III-IV melanoma that has been removed by surgery (resectable), has spread to other places in the body (metastatic), or is unable to be removed by surgery (unresectable), and who are being treated with the immunotherapy drugs pembrolizumab or nivolumab as part of their standard of care. Both diets are whole foods diets that meet the American Cancer Society recommendations for cancer patients, but they will vary in fiber content. The purpose of this trial is to learn about the effects of dietary interventions on the structure and function of the gut microbiome in patients with melanoma being treated with standard of care immunotherapy (pembrolizumab or nivolumab).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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:
  • - 1 Adjuvant Melanoma: i.
Resected Stage II-IV melanoma with planned initiation of adjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3.
  • - 2 Unresectable Melanoma: i.
Histologically confirmed unresectable stage III or Stage IV melanoma with planned initiation of standard of care anti-PD1 +/- CTLA4 or anti-PD1 +/- LAG3 immunotherapy and no prior immunotherapy in the metastatic setting.
  • - 3 Neoadjuvant Melanoma: i.
Histologically confirmed stage III/IV melanoma with planned initiation of neoadjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 1. Participants must have archival tissue block available or be willing to undergo a newly-obtained core needle or incisional biopsy at baseline. Fine needle aspiration is not acceptable.
  • - 4 Unresectable RCC: i.
Unresectable clear-cell renal cell carcinoma with planned initiation of standard of care anti-PD1 +/- anti-CTLA4 immunotherapy.

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. 15. Cognitively impaired adults

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04645680
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jennifer McQuade
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVE: To establish the effects of dietary intervention on the structure and function of the gut microbiome. SECONDARY OBJECTIVES: 1. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism. 2. Assess the effects of dietary intervention on systemic and tumor immunity. 3. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention. 4. Assess the rate of immune related adverse events in patients on immunotherapy receiving dietary interventions. 5. Determine the maximum daily fiber content that 70% of participants are able to tolerate. 6. Assess the adherence to the dietary interventions as defined by 70% of calories consumed over the duration of the study being derived from provided diets (as measured by food records) 7. Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) EXPLORATORY OBJECTIVES: 1. Assess the association of dietary interventions with clinical outcomes (objective response rate [ORR] and progression-free survival [PFS] rate in unresectable cohort and recurrence rate [RR] in adjuvant cohort). 2. Explore predictors of biological response to dietary interventions. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (ISOCALORIC HIGH-FIBER DIET): Patients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks. ARM II (ISOCALORIC CONTROL DIET): Patients receive a standard whole foods diet of recommended by the American Cancer Society for 11 weeks. After completion of study, patients are followed up at 12 weeks.

Arms & Interventions

Arms

Experimental: Arm I (isocaloric high-fiber diet)

Patients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks.

Active Comparator: Arm II (isocaloric diet)

Patients receive a standard whole foods diet recommended by the American Cancer Society for 11 weeks.

Interventions

Other: - Dietary Intervention

Consume isocaloric whole foods diet higher in fiber

Other: - Dietary Intervention

Whole foods diet

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Jennifer McQuade

[email protected]

713-745-9947

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