[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458574":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":55,"collaborators":23,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":23,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":23,"enrollmentInfo":66,"targetDuration":23,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":23,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A: FMT from an ICI non-responding donor","EXPERIMENTAL","Patients will receive FMT from an ICI non-responding donor (defined as ≥20% increase according to RECIST 1.1 criteria within the past 3 months). Patients will continue their anti-PD-1 treatment.",[13],"Other: Fecal microbiota transplantation",{"label":15,"type":10,"description":16,"interventionNames":17},"B: FMT from an ICI responding donor","Patients will receive FMT from an ICI responding donor (defined as ≥30% decrease or disappearance of all lesions according to RECIST 1.1 criteria within the past 24 months). Patients will continue their anti-PD-1 treatment.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Fecal microbiota transplantation","Fecal microbiota transplantation of an ICI responding or Fecal microbiota transplantation from an ICI non-responding donor, in combination with ICI.",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"John Haanen, Prof","Medical Oncologist","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","+31205129111","j.haanen@nki.nl",{"name":35,"role":31,"phone":32,"phoneExt":23,"email":36},"Femke Burgers, MD","f.burgers@nki.nl",[38],{"facility":39,"status":40,"city":41,"state":23,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Antoni van Leeuwenhoek","RECRUITING","Amsterdam","1066CX","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.88969,52.37403,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":54,"phoneExt":23,"email":36},"Femke Burgers","+31 20 512 9111",{"type":56,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100458574","phase-1-fmt-to-convert-response-to-immunotherapy-100458574",false,"NCT05251389","FMT to Convert Response to Immunotherapy","Conversion of Unresponsiveness to Immunotherapy by Fecal Microbiota Transplantation in Patients With Metastatic Melanoma: a Randomized Phase Ib\u002FIIa Trial","Inclusion Criteria:\n\n* Patients should be 18 years or older\n* Patients have pathologically confirmed advanced stage cutaneous melanoma (stage III or IV) requiring systemic treatment with anti-PD-1\n\n  * In case of stage IV disease, only patients with M1a or M1b disease are eligible.\n* Patients have confirmed disease progression (≥20% increase according to RECIST1.1) on two consecutive scans with a four week interval while on anti-PD-1 treatment, of which the second scan has to be performed within 3 weeks prior to signing informed consent.\n* Patients must have measurable disease per RECIST 1.1 criteria\n* Patients have an ECOG performance status of 0-1 (appendix D)\n* Patients have a life expectancy of \\>3 months\n* Patients have adequate organ function as determined by standard-of-care pre-checkpoint inhibitor infusion lab (including serum ALAT\u002FASAT less than three times the upper limit of normal (ULN); serum creatinine clearance 50ml\u002Fmin or higher; total bilirubin less than or equal to 20 micromol\u002FL, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 50 micromol\u002FL)\n* Patients have an LDH level of ≤1 times ULN\n* Patients of both genders must be willing to use a highly effective method of birth control during treatment\n* Patients must be able to understand and sign the Informed Consent document\n\nExclusion Criteria:\n\n* Patients with acral, uveal or mucosal melanoma, or patients with an unknown primary\n* Patients who have received treatment for their melanoma other than anti-PD-1 treatment.\n* Stage IV patients with M1c or M1d disease.\n* Patients with autoimmune diseases: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study (except Hashimoto thyroiditis, vitiligo, history of psoriasis, but no active disease)\n* Patients with any grade 3 or 4 immune-related adverse events still requiring active immunosuppressive medication, apart from endocrinopathies that are stable under hormone replacement therapy. Patients who had developed grade 3-4 immune related toxicity, which has reverted to grade I with immunosuppressive drugs and who are off immunosuppression at least two weeks prior to enrollment are eligible\n* Patients with brain or LM metastasis.\n* Patients with an elevated LDH level\n* Patients that have undergone major gastric\u002Fesophageal\u002Fbowel surgery (like Wipple, subtotal colectomy)\n* Severe food allergy (e.g. nuts, shellfish)\n* Patients with a swallowing disorder or expected bowel passage problems (ileus, fistulas, perforation)\n* Severe dysphagia with incapability of swallowing 2 liters of bowel lavage\n* Patients with a life expectancy of less than three months\n* Patients with severe cardiac or pulmonary comorbidities (per judgement of the investigator)\n* Women who are pregnant or breastfeeding\n* Patients with any active systemic infections, coagulation disorders or other active major medical illnesses\n* Patients with other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years\n* Patients who received treatment with antibiotics in the three months prior to study enrolment, or patients we are expected to receive systemic antibiotics during the course of this study","ALL","18 Years",{"count":67,"type":68},24,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","In this study the aim is to investigate whether transfer of the microbiota of either responder or non-responder patients via fecal microbiotica transplantation (FMT) can convert the response to immunotherapy in immune checkpoint inhibitors (ICI) refractory metastatic melanoma patients.\n\nThis is a randomized double-blind intervention phase Ib\u002FIIa trial in ICI refractory metastatic melanoma patients receiving either FMT of an ICI responding or FMT from an ICI non-responding donor, in combination with ICI.\n\nFollowing randomization, patients will receive vancomycin 250 mg, four times daily for 4 days (day -5 up until day -2), and undergo bowel clearance on day -1 (in total 1L MoviPrep). The FMT, either derived from donor group R (who showed a good response on anti-PD-1 therapy) or donor group NR (who showed progression on anti-PD-1 therapy), will be performed by a gastroenterologist using esophagogastroduodenoscopy. A total amount of 198mL (containing a total of 60 gram feces) will be used for transplantation. Anti-PD-1 treatment will be continued according to the patient's regular treatment schedule. Evaluation of safety and response to treatment will be performed.",[75,76],"Melanoma Stage III","Melanoma Stage IV","2025-03-07",{"date":79,"type":80},"2025-03-10","ACTUAL",{"date":82,"type":80},"2022-08-31",{"date":84,"type":68},"2026-08",{"name":5,"class":6},1]