RECRUITING

Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

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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 Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.

Official Title

Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

Quick Facts

Study Start:2024-09-16

Study Completion:2030-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06548789

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. Body mass index (BMI) 18.5-45 kg/m2 3. English-speaking 4. ECOG performance status of 0 or 1 5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review 6. Planned initiation of standard-of-care neoadjuvant Ipilimumab + Nivolumab or Nivolumab + Relatlimab 7. Measurable disease per RECIST 1.1 8. WOCP must have negative UPT within 1 week of beginning dietary intervention. 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. 11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.	1. Uveal melanoma 2. History of inflammatory bowel disease, total colectomy, or bariatric surgery 3. Currently taking steroids \> Prednisone 10 mg/day or equivalent 4. Medical contraindications to the Intervention Diet as determined by the treating physician. 5. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting. 6. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants 7. Unable or unwilling to undergo study procedures. 8. IV antibiotic use in the past month or oral antibiotic use in past 2 weeks 9. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study 10. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use 11. Currently pregnant, planning to become pregnant, or lactating 12. Concurrent malignancy requiring systemic therapy other than hormonal therapy 13. Cognitively impaired adults

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years old.
2. Body mass index (BMI) 18.5-45 kg/m2
3. English-speaking
4. ECOG performance status of 0 or 1
5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
6. Planned initiation of standard-of-care neoadjuvant Ipilimumab + Nivolumab or Nivolumab + Relatlimab
7. Measurable disease per RECIST 1.1
8. WOCP must have negative UPT within 1 week of beginning dietary intervention.
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.
11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.

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

Contacts and Locations

Study Contact

Jennifer McQuade, MD

CONTACT

(713) 745-9947

mcquade@mdanderson.org

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 Date2024-09-16

Study Completion Date2030-09-01

Study Record Updates

Study Start Date2024-09-16

Study Completion Date2030-09-01

Terms related to this study

Additional Relevant MeSH Terms

Melanoma