[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505772":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":89,"collaborators":23,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":23,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":23,"enrollmentInfo":100,"targetDuration":23,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":23,"overallStatus":38,"whyStopped":23,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"EverImmune","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 2 - NSCLC","EXPERIMENTAL","Oncobax-AK (1 capsule) will be administered daily until PD\\\u003C excessive toxicity or withdrawal of consent",[13],"Other: Live Bacterial Product - Akkermansia muciniphila",{"label":15,"type":10,"description":11,"interventionNames":16},"Phase 2 -RCC",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"OTHER","Live Bacterial Product - Akkermansia muciniphila","Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"Fabrice Barlesi, MD, PhD","Gustave Roussy, Cancer Campus, Grand Paris","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":23,"email":34},"Alain Thibault, MD","CONTACT","+32472196345","alain.thibault@everimmune.com",[36,51,64,78],{"facility":37,"status":38,"city":39,"state":23,"zip":23,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"CHU Ambroise Paré","RECRUITING","Mons","Belgium","BE",{"type":43,"coordinates":44},"Point",[45,46],3.95229,50.45413,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":23,"phoneExt":23,"email":23},"Stephane Holbrechts, MD",{"facility":52,"status":38,"city":53,"state":23,"zip":23,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Centre Georges Francois Leclerc","Dijon","France","FR",{"type":43,"coordinates":57},[58,59],5.01391,47.31344,{"lat":59,"lon":58},[62],{"name":63,"role":32,"phone":23,"phoneExt":23,"email":23},"Francois Ghiringhelli, MD, PhD",{"facility":65,"status":38,"city":66,"state":23,"zip":23,"country":54,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Institut Gustave Roussy","Paris",{"type":43,"coordinates":68},[69,70],2.3488,48.85341,{"lat":70,"lon":69},[73,75],{"name":74,"role":32,"phone":23,"phoneExt":23,"email":23},"Laurence Albiges, MD, PhD",{"name":76,"role":77,"phone":23,"phoneExt":23,"email":23},"Lisa Derosa, Md, PhD","SUB_INVESTIGATOR",{"facility":79,"status":38,"city":80,"state":23,"zip":23,"country":54,"countryCode":55,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"ICANS - Institut de cancérologie Strasbourg","Strasbourg",{"type":43,"coordinates":82},[83,84],7.74553,48.58392,{"lat":84,"lon":83},[87],{"name":88,"role":32,"phone":23,"phoneExt":23,"email":23},"Philippe Barthelemy, MD, PhD",{"type":90,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100505772","phase-2-a-study-of-oncobax-ak-in-patients-with-advanced-solid-tumors-100505772",false,"NCT05865730","A Study of Oncobax®-AK in Patients With Advanced Solid Tumors","A Phase 1\u002F2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC\n3. NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease\n4. NSCLC-specific criterion: PD-L1 expression \\> 50%\n5. ECOG Performance Status = 0-1\n6. Negative stool PCR test for Akkermansia\n7. At least one measurable lesion per iRECIST\n8. Hemoglobin ≥ 100 g\u002FL\n9. Albumin \\> 35 g\u002FL\n10. Signed informed consent\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases\n2. AST or ALT \\> 5 x ULN\n3. Calculated creatinine clearance \\\u003C 45 ml\u002Fmin\n4. Auto-immune diseases requiring systemic therapy\n5. Immunosuppressive therapy (\\> 10 mg prednisone\u002Fday equivalent)\n6. Radiotherapy (\\> 30 Gy) to the lung(s) within 6 months of signed informed consent\n7. Active infection\n8. Co-morbidities that may increase the risk of treatment-related adverse events\n9. Pregnancy\n10. Inability to comply with protocol-specific assessments","ALL","18 Years",{"count":101,"type":102},122,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract.\n\nAnalysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore \u002F improve the efficacy of immunotherapy in patients with NSCLC or RCC.",[108,109],"Carcinoma, Renal Cell","Carcinoma, Non-Small-Cell Lung","2023-05-09",{"date":112,"type":113},"2023-05-19","ACTUAL",{"date":115,"type":113},"2022-10-01",{"date":117,"type":102},"2026-06",{"name":5,"class":6},4]