[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650202":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":47,"centralContacts":51,"locations":33,"responsibleParty":57,"collaborators":33,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":33,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":33,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":79,"whyStopped":33,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":33},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Telisotuzumab Adizutecan Dose A + Pembrolizumab","EXPERIMENTAL","Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 38 month study duration.",[13,14],"Drug: Telisotuzumab Adizutecan","Drug: Pembrolizumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Telisotuzumab Adizutecan Dose B + Pembrolizumab","Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 38 month study duration.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Pembrolizumab + Platinum Chemotherapy + Fluorouracil","ACTIVE_COMPARATOR","Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 38 month study duration.",[14,24,25,26],"Drug: Carboplatin","Drug: Cisplatin","Drug: Fluorouracil",[28,34,38,41,44],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Telisotuzumab Adizutecan","Intravenous (IV)",[9,16],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Pembrolizumab","IV",[20,9,16],{"type":29,"name":39,"description":36,"armGroupLabels":40,"otherNames":33},"Carboplatin",[20],{"type":29,"name":42,"description":36,"armGroupLabels":43,"otherNames":33},"Cisplatin",[20],{"type":29,"name":45,"description":36,"armGroupLabels":46,"otherNames":33},"Fluorouracil",[20],[48],{"name":49,"affiliation":5,"role":50},"ABBVIE INC.","STUDY_DIRECTOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":33,"email":56},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",{"type":58,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100650202","a-study-to-assess-adverse-events-change-in-disease-activity-and-optimal-dose-of-intravenous-iv-telisotuzumab-adizutecan-with-iv-pembrolizumab-for-first-line-treatment-of-adult-participants-with-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100650202",false,"NCT07744126","A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan With IV Pembrolizumab for First-Line Treatment of Adult Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","A Phase 2 Open-Label Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Pembrolizumab as First-Line Treatment in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable by local therapies.\n* Eastern cooperative oncology group (ECOG) performance status must be \\\u003C= 1.\n* Must have c-Met protein expression by central c-Met immunohistochemistry (IHC) staining at any intensity in \\>= 25% tumor cells.\n* Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n* Must have had no prior systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).\n\nExclusion Criteria:\n\n* Have history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis on screening chest computed tomography (CT) scan.\n* Have any major, life-threatening conditions.\n* Life expectancy should be at least 3 months.","ALL","18 Years",{"count":69,"type":70},150,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide with an annual incidence of approximately 700,000 cases. This study aims to evaluate the change in disease activity and optimal dose, and optimal dose of telisotuzumab adizutecan in combination with pembrolizumab as first-line treatment in participants with recurrent or metastatic head and neck squamous cell carcinoma.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of recurrent or metastatic HNSCC. Participants are placed into 3 treatment groups called treatment arms. Each group receives a different treatment. Adult participants diagnosed with recurrent or metastatic HNSCC who have not received prior systemic therapy for advanced disease and whose tumors express c-Met protein will be enrolled. Approximately 180 participants will be enrolled in the study at sites worldwide.\n\nParticipants will receive intravenous doses of telisotuzumab adizutecan with intravenous pembrolizumab, or standard of care (SOC) chemotherapy with pembrolizumab. Participants will receive treatment as part of a 38 month study duration.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits every 3 weeks during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[76],"Head and Neck Squamous Cell Carcinoma",[76,30,35,78],"Cancer","NOT_YET_RECRUITING","2026-08-06",{"date":82,"type":83},"2026-08-10","ACTUAL",{"date":85,"type":70},"2026-09-30",{"date":87,"type":70},"2029-10",{"name":5,"class":6}]