[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441382":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":60,"collaborators":22,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":22,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":22,"enrollmentInfo":70,"targetDuration":22,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":22,"overallStatus":44,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"pembrolizumab, docetaxel, and cisplatin or carboplatin","IV",[12,13,14,15],"Drug: Pembrolizumab","Drug: Docetaxel","Drug: Cisplatin","Drug: Carboplatin",[17,23,26,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Pembrolizumab","given by IV",[9],null,{"type":18,"name":24,"description":20,"armGroupLabels":25,"otherNames":22},"Docetaxel",[9],{"type":18,"name":27,"description":20,"armGroupLabels":28,"otherNames":22},"Cisplatin",[9],{"type":18,"name":30,"description":20,"armGroupLabels":31,"otherNames":22},"Carboplatin",[9],[33],{"name":34,"affiliation":5,"role":35},"Renata Ferrarotto","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":22,"email":40},"CONTACT","(713) 745-6774","rferrarotto@mdanderson.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-95.36327,29.76328,{"lat":54,"lon":53},[57,59],{"name":34,"role":38,"phone":58,"phoneExt":22,"email":40},"713-745-6774",{"name":34,"role":35,"phone":22,"phoneExt":22,"email":22},{"type":61,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100441382","phase-2-immunotherapy-with-chemotherapy-and-chemoradiation-for-advanced-squamous-cancer-of-nasal-cavity--paranasal-sinuses-i-napa-100441382",false,"NCT05027633","Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity \u002F Paranasal Sinuses (I-NAPA)","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and\u002For cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.\n* Male participants:\n\nA male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n-Female participants:\n\nA female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.\n\n   * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n   * Have measurable disease based on RECIST 1.1.\n   * Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n   * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Patients must not have received prior systemic anti-cancer therapy including investigational agents or radiation therapy for PNS SCC but could have received treatment for prior cancers if greater than 2 years (refer to Item 8 for further details).","ALL","18 Years",{"count":71,"type":72},35,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This is a single arm phase II study that will evaluate the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as single treatment modality in patients with stage II-IVb (T2-4, any N, M0) squamous cell carcinoma of the nasal cavity\u002Fparanasal sinuses (PNS SCC).",[78,79,80],"Squamous Cell Carcinoma","the Nasal Cavity","Paranasal Sinuses","2026-03-18",{"date":83,"type":84},"2026-03-20","ACTUAL",{"date":86,"type":84},"2021-11-02",{"date":88,"type":72},"2028-03-30",{"name":5,"class":6},1]