[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610671":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":54,"collaborators":21,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":21,"enrollmentInfo":66,"targetDuration":21,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"UNICANCER","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm immunotherapy with Ipilimumab and nivolumab intra-tumoral administration","EXPERIMENTAL","Patients will receive up to 3 doses of neo-adjuvant treatment with IT injections of ipilimumab (5mg\u002FmL) \\& nivolumab (10mg\u002FmL) at 3-week intervals (±3 days) for up to 6 weeks prior to surgery.",[13,14],"Drug: Ipilimumab (YervoyTM, 50 mg\u002F10 mL solution)","Drug: Nivolumab (OpdivoTM, 40 mg\u002F4mL solution)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Ipilimumab (YervoyTM, 50 mg\u002F10 mL solution)","The 25 mg flat dose of the Ipilimumab will be administered by intra-tumoral injection. Injections will be performed under image guidance (the most adequate according to investigators preference). Ultrasound guidance will be privileged, as it is not using radiation. A maximum of 3 intratumoral procedures may occur with 3 weeks intervals prior to surgery.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Nivolumab (OpdivoTM, 40 mg\u002F4mL solution)","The 30 mg flat dose of the Nivolumab will be administered by intra-tumoral injection. Injections will be performed under image guidance (the most adequate according to investigators preference). Ultrasound guidance will be privileged, as it is not using radiation. A maximum of 3 intratumoral procedures may occur with 3 weeks intervals prior to surgery.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Priyanka DEVI-MARULKAR, PhD, MBA","CONTACT","+33(0)662536043","p-devi-marulkar@unicancer.fr",[33],{"facility":34,"status":35,"city":36,"state":21,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Gustave Roussy","RECRUITING","Villejuif","94805","France","FR",{"type":41,"coordinates":42},"Point",[43,44],2.35992,48.7939,{"lat":44,"lon":43},[47,51],{"name":48,"role":29,"phone":49,"phoneExt":21,"email":50},"Caroline ROBERT, MD, PhD","33(0) 1 42 11 42 53","Caroline.ROBERT@gustaveroussy.fr",{"name":52,"role":53,"phone":21,"phoneExt":21,"email":21},"Caroline ROBERT, MD, PHD","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100610671","phase-2-neo-adjuvant-immunotherapy-in-patients-with-localized-melanoma-100610671",false,"NCT07230613","Neo-adjuvant Immunotherapy in Patients With Localized Melanoma","Neo-adjuvant Intratumoral Anti-CTLA4 + Anti-PD1 in Patients With Localized Melanoma","NEOREM-NEO-1","In addition to NEOREM Master Protocol inclusion and exclusion criteria, the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial:\n\nInclusion Criteria:\n\n1. Patients ≥ 18 years old.\n2. Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma.\n3. Patients who received anti-PD-1 and stopped treatment \\> 6 months prior to their inclusion in NEO-1 trial are eligible.\n4. Patients who received target therapy and stopped treatment \\> 3 months prior to their inclusion in NEO-1 trial are eligible.\n\nExclusion Criteria:\n\n1. Patients with clinically or radiologically detectable distant metastases.\n2. Patients with uveal melanoma.\n3. Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and\u002F ipilimumab.\n4. Patients without pathological evaluable disease according to RECIST v1.1 criteria.","ALL","18 Years",{"count":67,"type":68},50,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response. Intratumoral (IT) delivery of immunostimulating agents reduces the systemic toxicity associated with monoclonal antibodies (mAbs) targeting immune checkpoints. Notably, IT injections of immune checkpoint blockade (ICB) have been shown to induce immune-mediated tumor responses both at the injected site and at distant, non-injected tumor sites. While surgery has traditionally been the preferred treatment for stage III and IV melanoma patients, neoadjuvant therapy with anti-CTLA-4 and anti-PD-1 agents has shown promising efficacy.\n\nIn patients with localized melanoma, it is hypothesized that IT administration of ipilimumab (anti-CTLA-4 Ab) combined with nivolumab (anti-PD-1 Ab) will provide the most effective and safe treatment combination.\n\nThe NEO-1 study is a proof-of-concept clinical trial designed as a sub-protocol of NEOREM master protocol (NCT07262489) to validate the intratumoral immunotherapy approach, aiming to maximize the dose\u002Fefficacy ratio of combined ipilimumab and nivolumab treatment while minimizing systemic adverse events. This is an academic, open-label, multicentric, phase II clinical trial evaluating the efficacy and safety of intratumoral injections of ipilimumab and nivolumab combination as neoadjuvant treatment in localized stage III resectable cutaneous or mucosal melanoma patients.\n\nBaseline and on-treatment PORTRAIT profiling, as described in the NEOREM Master Protocol (NCT07262489), will be performed using fresh blood and tumor samples. This profiling will reveal the immune status of patients and support biomarker-driven preselection for future trials.",[74,75],"Cutaneous Melanoma, Stage III","Mucosal Melanoma",[77,78,79,80,81],"Neo-adjuvant Immunotherapy","Localized Cancers","Intra-tumoral treatment","Melanoma","Immune-checkpoint blockade","2026-02-06",{"date":84,"type":85},"2026-02-11","ACTUAL",{"date":87,"type":85},"2026-01-12",{"date":89,"type":68},"2033-12",{"name":5,"class":6},1]