[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604884":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":129,"centralContacts":134,"locations":143,"responsibleParty":172,"collaborators":175,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":103,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":103,"enrollmentInfo":188,"targetDuration":103,"studyType":191,"phases":192,"briefSummary":194,"conditions":195,"keywords":103,"overallStatus":145,"whyStopped":103,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Emory University","OTHER",[8,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (nivolumab, ipilimumab)","EXPERIMENTAL","Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 0800-1100 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.",[13,14,15,16,17,18,19,20],"Procedure: Biopsy Procedure","Procedure: Biospecimen Collection","Procedure: Computed Tomography","Biological: Ipilimumab","Procedure: Magnetic Resonance Imaging","Other: Medical Device Usage and Evaluation","Biological: Nivolumab","Other: Questionnaire Administration",{"label":22,"type":10,"description":23,"interventionNames":24},"Arm II (nivolumab, ipilimumab)","Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 1100-1400 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.",[13,14,15,16,17,18,19,20],{"label":26,"type":27,"description":28,"interventionNames":29},"Arm III (nivolumab, ipilimumab)","ACTIVE_COMPARATOR","Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 1400-1700 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.",[13,14,15,16,17,18,19,20],[31,40,48,63,79,99,104,125],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Biopsy Procedure","Undergo tumor tissue biopsy",[9,22,26],[37,38,39],"Biopsy","BIOPSY_TYPE","Bx",{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Biospecimen Collection","Undergo check swab and blood sample collection",[9,22,26],[45,46,47],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":32,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Computed Tomography","Undergo CT",[9,22,26],[53,54,55,56,57,58,59,60,61,62],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"BIOLOGICAL","Ipilimumab","Given IV",[9,22,26],[69,70,71,72,73,74,75,76,77,78],"Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody","BMS 734016","BMS-734016","BMS734016","Ipilimumab Biosimilar CS1002","MDX 010","MDX-010","MDX-CTLA4","MDX010","Yervoy",{"type":32,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Magnetic Resonance Imaging","Undergo MRI",[9,22,26],[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"Medical Device Usage and Evaluation","Wear an actigraphy device",[9,22,26],null,{"type":64,"name":105,"description":66,"armGroupLabels":106,"otherNames":107},"Nivolumab",[9,22,26],[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo",{"type":6,"name":126,"description":127,"armGroupLabels":128,"otherNames":103},"Questionnaire Administration","Ancillary studies",[9,22,26],[130],{"name":131,"affiliation":132,"role":133},"Michael Lowe, MD, MA","Emory University Hospital\u002FWinship Cancer Institute","PRINCIPAL_INVESTIGATOR",[135,140],{"name":136,"role":137,"phone":138,"phoneExt":103,"email":139},"Michael C. Lowe, MD, MA","CONTACT","404-778-0680","mlowe3@emory.edu",{"name":141,"role":137,"phone":103,"phoneExt":103,"email":142},"Zachary Buchwald, MD, PhD","zachary.scott.buchwald@emory.edu",[144,162],{"facility":132,"status":145,"city":146,"state":147,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":156,"contacts":157},"RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":152,"coordinates":153},"Point",[154,155],-84.38798,33.749,{"lat":155,"lon":154},[158,161],{"name":159,"role":137,"phone":103,"phoneExt":103,"email":160},"Tiffaney Roundtree","tiffaney.laquinta.roundtree@emory.edu",{"name":136,"role":133,"phone":103,"phoneExt":103,"email":103},{"facility":163,"status":164,"city":146,"state":147,"zip":165,"country":149,"countryCode":150,"cosmosGeoPoint":166,"geoPoint":168,"contacts":169},"Emory Saint Joseph's Hospital","NOT_YET_RECRUITING","30342",{"type":152,"coordinates":167},[154,155],{"lat":155,"lon":154},[170,171],{"name":159,"role":137,"phone":103,"phoneExt":103,"email":160},{"name":136,"role":133,"phone":103,"phoneExt":103,"email":103},{"type":133,"investigatorFullName":173,"investigatorTitle":174,"investigatorAffiliation":5,"oldNameTitle":103,"oldOrganization":103},"Michael Lowe","Principal Investigator",[176],{"name":177,"class":178},"National Cancer Institute (NCI)","NIH","100604884","phase-2-time-of-day-specified-immunotherapy-for-advanced-melanoma-the-time-trial-100604884",false,"NCT07155317","Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial","The TIME Trial - Phase II Randomized Controlled Trial of Time-of-Day Specified Immunotherapy for Advanced Melanoma","Inclusion Criteria:\n\n* Pathologically confirmed American Joint Committee on Cancer (AJCC) 8th edition stage IV unresectable cutaneous, acral, or mucosal melanoma\n* No uveal melanoma\n* Patients with asymptomatic, non-hemorrhagic brain metastases \\\u003C 2 cm are eligible\n* No prior immunotherapy within 1 year, (serine\u002Fthreonine-protein kinase B-raf \\[BRAF\\]\u002Fmitogen-activated protein kinase \\[MEK\\] inhibitors allowed)\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n* Age ≥ 18\n* Adequate organ function to receive ipilimumab\u002Fnivolumab\n\nExclusion Criteria:\n\n* Immunosuppression (\\> 10mg prednisone daily)\n* Active autoimmune disease that would preclude the administration of immunotherapy\n* Active leptomeningeal disease","ALL","18 Years",{"count":189,"type":190},99,"ESTIMATED","INTERVENTIONAL",[193],"PHASE2","This phase II trial tests the safety and effectiveness of giving ipilimumab and nivolumab in the morning compared to other times of day in treating patients with melanoma that is stage IV or that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. While some patients have impressive outcomes with both of these drugs, over 40% of patients do not experience any clinical benefit. Studies have shown that the time of day that vaccines and other therapies are given have had an impact on response and survival. It is not known, however, whether time of day has an impact on response to immune checkpoint inhibitors, such as ipilimumab and nivolumab. Giving ipilimumab and nivolumab earlier in the day compared to later in the day may improve response to treatment and survival in patients with stage IV or unresectable melanoma.",[196,197,198,199,200,201,202,203,204,205],"Advanced Acral Melanoma","Advanced Cutaneous Melanoma","Advanced Mucosal Melanoma","Clinical Stage IV Cutaneous Melanoma AJCC v8","Metastatic Acral Melanoma","Metastatic Cutaneous Melanoma","Metastatic Mucosal Melanoma","Unresectable Acral Melanoma","Unresectable Cutaneous Melanoma","Unresectable Mucosal Melanoma","2025-11-10",{"date":208,"type":209},"2025-11-12","ACTUAL",{"date":211,"type":209},"2025-10-29",{"date":213,"type":190},"2027-12-31",{"name":5,"class":6},2]