[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489404":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":40,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":11,"overallStatus":23,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Early discontinuation of nivolumab","EXPERIMENTAL",null,[13],"Drug: nivolumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","nivolumab","Early discontinuation of nivolumab maintenance therapy in patients with irresectable stage III or metastatic melanoma",[9],[21],{"facility":22,"status":23,"city":24,"state":11,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Erasmus MC","RECRUITING","Rotterdam","3015GD","Netherlands","NL",{"type":29,"coordinates":30},"Point",[31,32],4.47917,51.9225,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Astrid A.M. van der Veldt, Dr.","CONTACT","+31107041754","a.vanderveldt@erasmusmc.nl",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","A.A.M. van der Veldt","Doctor","100489404","safe-stop-ipilimumab-nivolumab-ipi-nivo-trial-100489404",false,"NCT05652673","Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial","Safe Stop IPI-NIVO Trial: Early Discontinuation of Nivolumab Upon Achieving a (confirmed) Complete or Partial Response in Patients with Irresectable Stage III or Metastatic Melanoma Treated with First-line Ipilimumab-nivolumab","Inclusion Criteria:\n\n* 18 years of age or older\n* Irresectable stage III or metastatic melanoma\n* Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:\n\n  * previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed\n  * in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.\n* Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2\u002F+6) weeks from the start of ipilimumab-nivolumab:\n\n  * for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET\u002FCT) is allowed at baseline\n  * for patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET\u002FCT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria 30\n  * in case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI for response evaluation prior to inclusion in this study.\n* Patients should be included after first CR\u002FPR or first confirmed CR\u002FPR according to RECIST v1.1 30:\n\n  * inclusion should take place no later than 5 weeks after first confirmed CR\u002FPR\n  * in case of SD at first response evaluation, confirmed CR\u002FPR is required for inclusion\n  * planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR\u002FPR or first confirmed CR\u002FPR\n  * no later than 9 months after start of treatment with ipilimumab-nivolumab\n* Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab)\n* Participants with previously locally treated brain metastases may participate in case they meet the following criteria:\n\n  * completely asymptomatic brain metastases at inclusion\n  * MRI of brain at baseline and for response evaluation during treatment\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* Patients with SD\u002FPD according to RECIST v1.1\n* Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.\n* Presence of symptomatic brain metastases:\n\n  * prior to first-line treatment with ipilimumab-nivolumab, or;\n  * when defined as new or progressive brain metastases at the time of study entry;\n  * brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion.\n\n(provided that the other in- and exclusion criteria are met);\n\n* Presence of leptomeningeal metastases;\n* Systemic chronic steroid therapy (\\>10mg\u002Fday prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the treatment of immune related adverse events (irAEs). Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial","ALL","18 Years",{"count":54,"type":55},80,"ESTIMATED","INTERVENTIONAL",[58],"NA","Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab",[61,62,63,64],"Melanoma Stage IV","Melanoma Stage III","Immunotherapy","Toxicity, Drug","2025-02-26",{"date":67,"type":68},"2025-02-28","ACTUAL",{"date":70,"type":68},"2023-02-01",{"date":72,"type":55},"2029-12-01",{"name":5,"class":6},1]