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Recruiting Phase 2

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

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About this study

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

Condition
Melanoma
Tested
Prebiotic Xnack Packouts
Sponsor
M.D. Anderson Cancer Center

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Study condition: Melanoma
  • Age ≥ 18 years old.
  • Body mass index (BMI) 18.5-45 kg/m2
  • Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
  • ECOG performance status of 0 or 1
  • Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
  • Planned initiation of standard-of-care neoadjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec (T-VEC)
  • Measurable disease per RECIST 1.1
  • WOCP must have negative UPT within 1 week of beginning dietary intervention.
  • Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
  • Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
  • Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.

Exclusion 13

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

Where

1 site, 1 recruiting

MD Anderson Cancer Center

Houston, Texas, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.