Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT06466434
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unresectable Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.', 'detailedDescription': 'Primary Objectives\n\n• Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks\n\nSecondary Objectives\n\n* Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance)\n* Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens\n* Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks\n* Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks\n* Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks\n* Assess the effects of dietary intervention on systemic and tumor immunity\n* Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks\n* Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks\n* Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden\n* Body mass index (BMI) 18.5-45 kg/m2\n* ECOG performance status of 0 or 1\n* Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral, or mucosal melanoma. Asymptomatic brain metastases are allowed.\n* 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.\n* Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)\n* WOCP must have negative UPT within 1 week of beginning dietary intervention.\n* Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)\n* Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.\n\nExclusion Criteria:\n\n* Previous ICB treatment in the metastatic setting\n* History of inflammatory bowel disease, total colectomy, or bariatric surgery.\n* Currently taking steroids \\> Prednisone 10 mg/day or equivalent\n* Medical contraindications to the Intervention Diet as determined by the treating physician.\n* Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.\n* Insulin-dependent diabetes or condition requiring bile acid sequestrants\n* Unable or unwilling to undergo study procedures.\n* IV antibiotic use in the past month or oral antibiotic use in past 2 weeks.\n* Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study.\n* Current smoker or heavy drinker (defined as \\>14 drinks per week) or current illicit drug use.\n* Currently pregnant, planning to become pregnant, or lactating.\n* Concurrent malignancy requiring systemic therapy other than hormonal therapy.\n* Cognitively impaired adults'}, 'identificationModule': {'nctId': 'NCT06466434', 'briefTitle': 'Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma', 'orgStudyIdInfo': {'id': '2024-0387'}, 'secondaryIdInfos': [{'id': 'NCI-2024-05150', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prebiotic food-enriched diet (PreFED)', 'description': 'Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.', 'interventionNames': ['Other: Prebiotic Food-Enriched Diet']}], 'interventions': [{'name': 'Prebiotic Food-Enriched Diet', 'type': 'OTHER', 'description': 'Given by PO', 'armGroupLabels': ['Prebiotic food-enriched diet (PreFED)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer McQuade, MD', 'role': 'CONTACT', 'email': 'jmcquade@mdanderson.org', 'phone': '713-745-9947'}, {'name': 'Jennifer McQuade, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jennifer McQuade, MD', 'role': 'CONTACT', 'email': 'jmcquade@mdanderson.org', 'phone': '(713) 745-9947'}], 'overallOfficials': [{'name': 'Jennifer McQuade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}