[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441382":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":26,"studyPopulation":11,"armGroups":27,"interventions":36,"overallOfficials":51,"centralContacts":55,"locations":60,"responsibleParty":79,"collaborators":11,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":11,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":11,"enrollmentInfo":89,"targetDuration":11,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"To increase overall response rate (ORR)",null,"through study completion, an average of 1 year",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"To improve the following efficacy endpoints relative to historical results with chemotherapy alone",{"measure":17,"description":11,"timeFrame":12},"To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC",{"measure":19,"description":11,"timeFrame":12},"To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC",{"allocation":21,"interventionModel":22,"interventionModelDescription":11,"primaryPurpose":23,"observationalModel":11,"timePerspective":11,"maskingInfo":24},"NA","SINGLE_GROUP","TREATMENT",{"masking":25,"maskingDescription":11,"whoMasked":11},"NONE","Primary Objective\n\n-Increase overall response rate (ORR), following pembrolizumab combined with induction chemotherapy prior to radiation, from historical 60% with induction chemotherapy alone to 80%.\n\nSecondary Objective\n\n* Improve the following efficacy endpoints relative to historical results with chemotherapy alone: progression free survival (PFS), overall survival (OS), organ \\[orbital, maxillary, cranial\\] preservation rate (OPR), and locoregional failure (LRF).\n* To determine safety and tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC.\n* Correlate immune phenotype in tumors and blood, including T cell infiltration and PD-L1 status, with treatment outcomes.",[28],{"label":29,"type":6,"description":30,"interventionNames":31},"pembrolizumab, docetaxel, and cisplatin or carboplatin","IV",[32,33,34,35],"Drug: Pembrolizumab","Drug: Docetaxel","Drug: Cisplatin","Drug: Carboplatin",[37,42,45,48],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"DRUG","Pembrolizumab","given by IV",[29],{"type":38,"name":43,"description":40,"armGroupLabels":44,"otherNames":11},"Docetaxel",[29],{"type":38,"name":46,"description":40,"armGroupLabels":47,"otherNames":11},"Cisplatin",[29],{"type":38,"name":49,"description":40,"armGroupLabels":50,"otherNames":11},"Carboplatin",[29],[52],{"name":53,"affiliation":5,"role":54},"Renata Ferrarotto","PRINCIPAL_INVESTIGATOR",[56],{"name":53,"role":57,"phone":58,"phoneExt":11,"email":59},"CONTACT","(713) 745-6774","rferrarotto@mdanderson.org",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-95.36327,29.76328,{"lat":73,"lon":72},[76,78],{"name":53,"role":57,"phone":77,"phoneExt":11,"email":59},"713-745-6774",{"name":53,"role":54,"phone":11,"phoneExt":11,"email":11},{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":90,"type":91},35,"ESTIMATED","INTERVENTIONAL",[94],"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).",[97,98,99],"Squamous Cell Carcinoma","the Nasal Cavity","Paranasal Sinuses","2026-09-17",{"date":102,"type":103},"2026-09-18","ACTUAL",{"date":105,"type":103},"2021-11-02",{"date":107,"type":91},"2028-03-30",{"name":5,"class":6},1]