Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-09 @ 11:12 PM
Study NCT ID:
NCT03353402
Status:
UNKNOWN
Last Update Posted:
2019-04-03
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '4 years', 'description': 'Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST.'}], 'primaryOutcomes': [{'measure': 'Incidence of FMT-related Adverse Events', 'timeFrame': '4 years', 'description': 'Number of patients with adverse events that emerged post FMT'}, {'measure': 'Proper implant engraftment', 'timeFrame': '4 years', 'description': "Comparing of the patients' gut bacterial composition pre and post-FMT and in relation to their donors. Bacterial composition will be quantified by the operational taxonomic unit (OTU) in the stool"}], 'secondaryOutcomes': [{'measure': 'Changes in composition of immune cell population', 'timeFrame': '4 years', 'description': 'Changes in the relative abundance of different immune cell population (such as the proportion of CD8+ T cells) pre and post-FMT.'}, {'measure': 'Changes in activity of immune cells', 'timeFrame': '4 years', 'description': 'Changes in levels of proteins that represent immune activity against cancer (such as measurements of blood interferon gamma levels), pre and post FMT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Fecal Microbiota Transplantation', 'Immunotherapy'], 'conditions': ['Melanoma Stage Iv', 'Unresectable Stage III Melanoma']}, 'referencesModule': {'references': [{'pmid': '36464584', 'type': 'DERIVED', 'citation': 'Villemin C, Six A, Neville BA, Lawley TD, Robinson MJ, Bakdash G. The heightened importance of the microbiome in cancer immunotherapy. Trends Immunol. 2023 Jan;44(1):44-59. doi: 10.1016/j.it.2022.11.002. Epub 2022 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients.\n\nFMT includes both colonoscopy and stool capsules.', 'detailedDescription': 'This is a phase I single-center study of fecal microbiota transplant (FMT) in melanoma patients who failed at least one line of PD-1 blockade.\n\nEligible patients must have a disease amenable to biopsy and lack of contra-indications to FMT.\n\nPatients will undergo a baseline evaluation including imaging, tumor biopsy, blood samples and stool studies to confirm suitability for the study.\n\nEligible patients will undergo FMT. The FMT includes a colonoscopy followed by stool capsules.\n\nPatients will undergo repeated evaluations including follow-up blood, stool and radiological testings.\n\nThe study will be conducted over a 24-week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A histologically confirmed diagnosis of metastatic melanoma.\n* Failed at least one line of PD-1 blockade.\n* ECOG Performance Status 0-2\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of absolute contra-indications to FMT administration.\n* Severe dietary allergies (e.g. shellfish, nuts, seafood).\n* Anatomic contra-indications to colonoscopy.\n* Inability to swallow capsules.\n* Current participation in a study of an investigational agent.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment.\n* History of bleeding disorder, chronic kidney disease, Inflammatory bowel disease.\n* History of a major abdominal surgery\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.'}, 'identificationModule': {'nctId': 'NCT03353402', 'briefTitle': 'Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients', 'orgStudyIdInfo': {'id': 'SHEBA-17-3956-GM-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal Microbiota Transplant (FMT)', 'description': 'FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.', 'interventionNames': ['Procedure: Fecal Microbiota Transplant (FMT)']}], 'interventions': [{'name': 'Fecal Microbiota Transplant (FMT)', 'type': 'PROCEDURE', 'description': 'Patients with metastatic melanoma who responded to immunotherapy will serve as the fecal implant donors. The tested fecal implant will be used for two different products. The first part of the tested stool will be mixed with a saline solution, strained and infused into your bowel using colonoscopy. The second part of the tested stool will be packed into capsules. These stool capsules are at the size of standard drug-containing capsules and can be swallowed in a standard manner. Stool capsules are a common method of FMT and has been used worldwide for several years. After the colonoscopy, you will be asked to swallow the capsules. Swallowing the capsules will be conducted at the clinic, and does not require any additional procedures.', 'armGroupLabels': ['Fecal Microbiota Transplant (FMT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5262620', 'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Erez N Baruch, MD', 'role': 'CONTACT', 'email': 'Erez.Baruch@sheba.health.gov.il', 'phone': '+972.530.4591'}, {'name': 'Ben S Boursi, MD', 'role': 'CONTACT', 'email': 'Ben.Boursi@sheba.health.gov.il', 'phone': '+972.530.2542'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Gal N Markel, MD,PhD', 'role': 'CONTACT', 'email': 'gal.markel@sheba.health.gov.il', 'phone': '+972.3.530.7093'}, {'name': 'Ben S Boursi, MD', 'role': 'CONTACT', 'email': 'Ben.Boursi@sheba.health.gov.il', 'phone': '+972.3.530.2542'}], 'overallOfficials': [{'name': 'Gal Markel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Scientist of The Ella Lemelbaum Institute of Immuno-Oncology, Principal Investigator, Associate Professor of Immunology', 'investigatorFullName': 'Prof. Gal Markel', 'investigatorAffiliation': 'Sheba Medical Center'}}}}