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NCT06548789 | RECRUITING | Melanoma

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

M.D. Anderson Cancer Center

Brief Summary:

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

Condition or disease

Melanoma

Intervention/treatment

Prebiotic Xnack Packouts

Phase

PHASE2

Detailed Description:

Primary Objectives: Determine the feasibility, compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy. Secondary Objectives: 1. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention during the neoadjuvant phase and maintenance phases 2. Assess the rate of immune related adverse events in patients of dietary intervention + ICB during neoadjuvant and maintenance phases. 3. Determine the objective response rate (ORR) to dietary intervention + ICB as determined by RECIST1.1 after 2 cycles of neoadjuvant ICB + diet 4. Determine the pathological response rate (pRR) to neoadjuvant ICB + dietary intervention 5. Determine the Event-free Survival (EFS), Relapse-free Survival (RFS), and Overall Survival (OS) to neoadjuvant ICB + dietary intervention Exploratory Objectives: 1. Assess the effect of dietary intervention + ICB on gut microbiome composition at completion of neoadjuvant phase and maintenance phase 2. Assess the effects of dietary intervention + neoadjuvant ICB on gut metabolic output and systemic metabolism at completion of neoadjuvant phase and maintenance phase 3. Assess the effects of dietary intervention + neoadjuvant ICB on systemic and tumor immunity at time of surgery 4. Assess the effects of dietary intervention + neoadjuvant ICB on quality of life and other patient reported outcomes (PROs) during neoadjuvant and maintenance phases

Study Type : INTERVENTIONAL
Estimated Enrollment : 35 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
Actual Study Start Date : 2024-09-16
Estimated Primary Completion Date : 2028-09-01
Estimated Study Completion Date : 2030-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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.
Exclusion Criteria
  • 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
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

Location Details

NCT06548789

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Locations

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030