Dietary intervention to improve immune therapy response in melanoma patients
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
This study is testing whether a special diet can help improve the response to immune therapy in patients with advanced melanoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06466434 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a prebiotic food-enriched diet (PreFED) on the gut microbiome in patients with unresectable melanoma who are beginning immune checkpoint blockade therapy. The primary objective is to evaluate changes in the abundance of specific gut bacteria over 12 weeks, while secondary objectives include assessing overall response rates, progression-free survival, and quality of life. Participants will adhere to the dietary intervention and undergo various assessments to monitor safety, tolerability, and immune responses. The study aims to understand how dietary changes can influence treatment outcomes in melanoma patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable melanoma who are starting first-line immune checkpoint blockade therapy.
Not a fit: Patients with resectable melanoma or those not starting immune checkpoint blockade therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of immunotherapy in melanoma patients by optimizing their gut microbiome.
How similar studies have performed: While the specific combination of dietary intervention and immune therapy is novel, similar studies exploring the gut microbiome's role in cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years old * English-speaking * Body mass index (BMI) 18.5-45 kg/m2 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed. * Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed. * Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally) * Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled. * 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. Exclusion Criteria: * Previous ICB treatment in the metastatic setting * 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 condition requiring bile acid sequestrants * Unable or unwilling to undergo study procedures. * IV antibiotic use in the past month or 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 this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Erez Baruch, MD,PHD — M.D. Anderson Cancer Center
- Study coordinator: Erez Baruch, MD,PHD
- Email: ENBaruch@mdanderson.org,
- Phone: 713-745-5530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.