Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Unresectable Melanoma Clinical Trial

Official title:

Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466434
• Other study ID #: 2024-0387
• Secondary ID: NCI-2024-05150
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 31, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jennifer McQuade, MD
• Phone: (713) 745-9947
• Email: jmcquade[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting ICI therapy.

Description:

Primary Objectives

• Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks

Secondary Objectives

• Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance)

• Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens

• Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks

• Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks

• Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks

• Assess the effects of dietary intervention on systemic and tumor immunity

• Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks

• Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks

• Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years old

• English-speaking

• Body mass index (BMI) 18.5-45 kg/m2

• ECOG performance status of 0 or 1

• Histologically confirmed stage III/IV, unresectable cutaneous 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) in the metastatic setting (prior ICB in adjuvant setting is allowed if last exposure = 6 months prior). Prior targeted therapy is also allowed.

• Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)

• 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:

• Uveal melanoma 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

Related Conditions & MeSH terms

• Melanoma
• Unresectable Melanoma

Intervention

Dietary Supplement:
• Prebiotic food-enriched diet (PreFED)
Given by PO

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and adverse events (AEs)	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year.

External Links

•   MD Anderson Cancer Center