[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551239":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":260,"collaborators":31,"id":262,"slug":263,"hasResults":264,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":264,"sex":270,"minAge":271,"maxAge":31,"enrollmentInfo":272,"targetDuration":31,"studyType":275,"phases":276,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},{"fullName":5,"class":6},"Coherus Oncology, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab + cisplatin (or carboplatin) + gemcitabine","EXPERIMENTAL","Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.",[13,14,15,16],"Drug: Toripalimab","Drug: Cisplatin","Drug: Gemcitabine","Drug: Carboplatin",[18,27,32,36],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Toripalimab","Participants will receive toripalimab via intravenous infusion (IV) on Day 1 every 3 weeks (Q3W) during the Chemotherapy-based treatment phase and Maintenance treatment phase.",[9],[24,25,26],"JS001","TAB-001","CHS-007",{"type":19,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Cisplatin","Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.",[9],null,{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Gemcitabine","Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.",[9],{"type":19,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Carboplatin","In the event of cisplatin-related nephrotoxicity or at the discretion of the investigator due to cisplatin-related poor tolerability, carboplatin can substitute for cisplatin use from cycle 2 onward. These participants will receive carboplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.",[9],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Clinical Operations Team Clinical Operations","CONTACT","800-794-5434","clinicaltrials@coherus.com",[47,68,84,102,118,135,153,169,179,195,210,227,243],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"University of Arkansas for Medical Sciences","RECRUITING","Little Rock","Arkansas","72205","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-92.28959,34.74648,{"lat":59,"lon":58},[62,65],{"name":63,"role":43,"phone":31,"phoneExt":31,"email":64},"Constance Brown","brownconstance@uams.edu",{"name":66,"role":67,"phone":31,"phoneExt":31,"email":31},"Santanu Samanta, MD","PRINCIPAL_INVESTIGATOR",{"facility":69,"status":49,"city":70,"state":71,"zip":72,"country":53,"countryCode":54,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University of California, Irvine","Irvine","California","92697",{"type":56,"coordinates":74},[75,76],-117.82311,33.66946,{"lat":76,"lon":75},[79,82],{"name":80,"role":43,"phone":31,"phoneExt":31,"email":81},"Shirin Attarian","sattari1@hs.uci.edu",{"name":83,"role":67,"phone":31,"phoneExt":31,"email":31},"Bao-An Huynh",{"facility":85,"status":49,"city":86,"state":71,"zip":87,"country":53,"countryCode":54,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University of California, San Francisco","San Francisco","94115",{"type":56,"coordinates":89},[90,91],-122.41942,37.77493,{"lat":91,"lon":90},[94,97,100],{"name":95,"role":43,"phone":31,"phoneExt":31,"email":96},"Luchia Andemicael","Luchia.Andemicael@ucsf.edu",{"name":98,"role":43,"phone":31,"phoneExt":31,"email":99},"Brittany Liu","Brittany.Liu@ucsf.edu",{"name":101,"role":67,"phone":31,"phoneExt":31,"email":31},"Sue S Yom, MD",{"facility":103,"status":49,"city":104,"state":105,"zip":106,"country":53,"countryCode":54,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Emory Winship Cancer Institute","Atlanta","Georgia","30322",{"type":56,"coordinates":108},[109,110],-84.38798,33.749,{"lat":110,"lon":109},[113,116],{"name":114,"role":43,"phone":31,"phoneExt":31,"email":115},"Madison Stallings","madison.miller.stallings@emory.edu",{"name":117,"role":67,"phone":31,"phoneExt":31,"email":31},"Dong Shin, MD",{"facility":119,"status":49,"city":120,"state":121,"zip":122,"country":53,"countryCode":54,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Boston Medical Center","Boston","Massachusetts","02118",{"type":56,"coordinates":124},[125,126],-71.05977,42.35843,{"lat":126,"lon":125},[129,133],{"name":130,"role":43,"phone":131,"phoneExt":31,"email":132},"Samantha Reilly","617-638-8271","samantha.reilly@bmc.org",{"name":134,"role":67,"phone":31,"phoneExt":31,"email":31},"Peter C Everett, MD",{"facility":136,"status":49,"city":137,"state":138,"zip":139,"country":53,"countryCode":54,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"University of Michigan","Ann Arbor","Michigan","48109",{"type":56,"coordinates":141},[142,143],-83.74088,42.27756,{"lat":143,"lon":142},[146,149,151],{"name":147,"role":43,"phone":148,"phoneExt":31,"email":31},"Cancer Answer Line","800-865-1125",{"name":31,"role":43,"phone":31,"phoneExt":31,"email":150},"CancerAnswerLine@med.umich.edu",{"name":152,"role":67,"phone":31,"phoneExt":31,"email":31},"Paul Swiecicki, MD",{"facility":154,"status":49,"city":155,"state":138,"zip":156,"country":53,"countryCode":54,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Henry Ford Cancer Center","Detroit","48202",{"type":56,"coordinates":158},[159,160],-83.04575,42.33143,{"lat":160,"lon":159},[163,167],{"name":164,"role":43,"phone":165,"phoneExt":31,"email":166},"Bethany Adams","248-224-7345","badams19@HFHS.ORG",{"name":168,"role":67,"phone":31,"phoneExt":31,"email":31},"Matthew Wilkins, MD",{"facility":170,"status":171,"city":172,"state":172,"zip":173,"country":53,"countryCode":54,"cosmosGeoPoint":174,"geoPoint":178,"contacts":31},"Laura & Isaac Perlmutter Cancer Center at NYU Langone Health","WITHDRAWN","New York","10016",{"type":56,"coordinates":175},[176,177],-74.00597,40.71427,{"lat":177,"lon":176},{"facility":180,"status":49,"city":181,"state":182,"zip":183,"country":53,"countryCode":54,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"University of Cincinnati Medical Center","Cincinnati","Ohio","45219",{"type":56,"coordinates":185},[186,187],-84.51439,39.12711,{"lat":187,"lon":186},[190,193],{"name":191,"role":43,"phone":31,"phoneExt":31,"email":192},"Audrey Romano","cragoay@ucmail.uc.edu",{"name":194,"role":67,"phone":31,"phoneExt":31,"email":31},"Trisha M Wise-Draper, M.D., Ph.D.",{"facility":196,"status":49,"city":197,"state":182,"zip":198,"country":53,"countryCode":54,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Cleveland Clinic","Cleveland","44195",{"type":56,"coordinates":200},[201,202],-81.69541,41.4995,{"lat":202,"lon":201},[205,208],{"name":206,"role":43,"phone":31,"phoneExt":31,"email":207},"Bridget Bush","bushb@ccf.org",{"name":209,"role":67,"phone":31,"phoneExt":31,"email":31},"Tamara Sussman, MD",{"facility":211,"status":49,"city":212,"state":213,"zip":214,"country":53,"countryCode":54,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Penn State Milton S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":56,"coordinates":216},[217,218],-76.65025,40.28592,{"lat":218,"lon":217},[221,225],{"name":222,"role":43,"phone":223,"phoneExt":31,"email":224},"CI-CTO","717-531-5471","psci-cto@pennstatehealth.psu.edu",{"name":226,"role":67,"phone":31,"phoneExt":31,"email":31},"Danh Pham, MD",{"facility":228,"status":49,"city":229,"state":230,"zip":231,"country":53,"countryCode":54,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":56,"coordinates":233},[234,235],-87.90647,43.0389,{"lat":235,"lon":234},[238,241],{"name":239,"role":43,"phone":31,"phoneExt":31,"email":240},"Sarah Kaehny","skaehny@mcw.edu",{"name":242,"role":67,"phone":31,"phoneExt":31,"email":31},"Stuart Wong, MD",{"facility":244,"status":49,"city":245,"state":31,"zip":246,"country":247,"countryCode":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Princess Margaret Cancer Centre","Toronto","MSG 1Z5","Canada","CA",{"type":56,"coordinates":250},[251,252],-79.39864,43.70643,{"lat":252,"lon":251},[255,258],{"name":256,"role":43,"phone":31,"phoneExt":31,"email":257},"Arundhati Shukla","Arundhati.shukla@uhn.ca",{"name":259,"role":67,"phone":31,"phoneExt":31,"email":31},"Anna Spreafico, MD, PhD",{"type":261,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100551239","phase-4-a-study-of-toripalimab-in-combination-with-cisplatin-and-gemcitabine-in-participants-with-recurrent-metastatic-nasopharyngeal-cancer-100551239",false,"NCT06457503","A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer","Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants","TRANSPARENT","Key Inclusion Criteria:\n\n* Histological or cytological confirmation of recurrent\u002Fmetastatic nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:\n\n  * EBER\u002FEBV-negative (HPV+\u002F-)\n  * EBER\u002FEBV-positive (HPV+\u002F-)\n* Recurrent\u002Fmetastatic (stage IV-B as defined by the International Union against Cancer \\[UICC\\] and American Joint Committee on Cancer \\[AJCC\\] staging system for nasopharyngeal cancer \\[NPC\\], eighth edition) or recurrent NPC after curative treatment. For recurrent NPC, more than 6 months between the last dose of radiotherapy or chemotherapy and the date of recurrence.\n* Measurable disease based on RECIST v 1.1 as determined by the site. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nKey Exclusion Criteria:\n\n* Disease that is suitable for local therapy administered with curative intent.\n* Prior systemic therapy administered in the recurrent or metastatic setting. Participants who develop disease recurrence within 6 months from curative intent chemoradiation will be excluded.\n* Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.\n* Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal), as determined on computerized tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments. Participants who have prior therapies for brain or leptomeningeal metastasis and have been stabilized ≥ 1 month and have discontinued systemic steroid therapy (\\>10 mg\u002Fday prednisone or equivalent) ≥ 1 month prior to enrollment are eligible.\n\nOther protocol-defined inclusion and exclusion criteria apply.","ALL","12 Years",{"count":273,"type":274},100,"ESTIMATED","INTERVENTIONAL",[277],"PHASE4","This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.",[280],"Nasopharyngeal Cancer Recurrent",[282,20,283],"Programmed death 1 [PD1] inhibitor","Recurrent metastatic nasopharyngeal cancer","2026-04-03",{"date":286,"type":287},"2026-04-06","ACTUAL",{"date":289,"type":287},"2024-11-01",{"date":291,"type":274},"2027-12",{"name":5,"class":6},13]