ACTIVE_NOT_RECRUITING

Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with ICI-refractory melanoma who are receiving the combination of ipilimumab and nivolumab as part of their standard care.

Official Title

Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients

Quick Facts

Study Start:2024-03-01

Study Completion:2029-01-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06250335

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years old 2. English-speaking 3. Body mass index (BMI) 18.5-45 kg/m2 4. ECOG performance status of 0 or 1 5. Histologically confirmed stage III/IV, unresectable cutaneous melanoma. Asymptomatic brain metastases are allowed. 6. Prior treatment with anti-PD1 or anti-PD-1 + anti-LAG3 agents and documented disease progression either while on these agents or after stopping therapy without intervening therapy. 7. Planned initiation of standard-of-care Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg 8. Measurable disease per RECIST 1.1 9. Self-reported willingness to eat the provided foods (with some tailoring to their food preferences) 10. Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.	1. Prior treatment with anti-CTLA4 2. Mucosal or uveal melanoma 3. Concurrent malignancy requiring systemic therapy other than hormonal therapy. 4. History of inflammatory bowel disease, total colectomy, or bariatric surgery 5. Currently taking steroids \> Prednisone 10 mg/day or equivalent 6. IV antibiotic use in the past month or oral antibiotic use in past 2 weeks 7. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study. 8. Medical contraindications to the Intervention Diet as determined by the treating physician. 9. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting. 10. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants. 11. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use. 12. Currently pregnant, planning to become pregnant, or lactating. 13. Cognitively impaired adults

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years old
2. English-speaking
3. Body mass index (BMI) 18.5-45 kg/m2
4. ECOG performance status of 0 or 1
5. Histologically confirmed stage III/IV, unresectable cutaneous melanoma. Asymptomatic brain metastases are allowed.
6. Prior treatment with anti-PD1 or anti-PD-1 + anti-LAG3 agents and documented disease progression either while on these agents or after stopping therapy without intervening therapy.
7. Planned initiation of standard-of-care Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg
8. Measurable disease per RECIST 1.1
9. Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
10. Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.

1. Prior treatment with anti-CTLA4
2. Mucosal or uveal melanoma
3. Concurrent malignancy requiring systemic therapy other than hormonal therapy.
4. History of inflammatory bowel disease, total colectomy, or bariatric surgery
5. Currently taking steroids \> Prednisone 10 mg/day or equivalent
6. IV antibiotic use in the past month or oral antibiotic use in past 2 weeks
7. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study.
8. Medical contraindications to the Intervention Diet as determined by the treating physician.
9. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.
10. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants.
11. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use.
12. Currently pregnant, planning to become pregnant, or lactating.
13. Cognitively impaired adults

Contacts and Locations

Principal Investigator

Jennifer McQuade, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Jennifer McQuade, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2029-01-23

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2029-01-23

Terms related to this study

Additional Relevant MeSH Terms

ICB-refractory Melanoma