[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sinonasal-undifferentiated-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sinonasal-undifferentiated-carcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":40,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100578684","phase-1-radiation-combined-with-bispecific-t-cell-engager-in-dll3-expressing-tumors-100578684",false,"NCT06814496","Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors","RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I\u002FII Study of AMG757 \u002F Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3","RABBIT","Inclusion Criteria:\n\n1. Subject has provided informed consent\u002Fassent prior to initiation of any study specific activities\u002Fprocedures.\n2. Subjects ≥ 18 years of age at the time of signing the informed consent.\n3. Histologically or cytologically confirmed relapsed\u002Frefractory:\n\n   1. SCLC\n   2. Other tumors of small cell histology\n   3. High grade \u002F poorly differentiated neuroendocrine histology tumor histologies with high prevalence of DLL3 (≥50% prevalence of ≥1% positivity), including but not limited to: melanoma, medullary thyroid cancer, esthesioneuroblastoma, bladder cancer, testicular cancer, glioblastoma multiforme, cervical cancer; large cell neuroendocrine tumor of lung, non-small cell lung cancers with mixed neuroendocrine features, and Merkel cell carcinoma OR\n   4. DLL3+ (≥1% by IHC) Note: If patients are DLL3 negative per IHC but have a DLL3 prevelant tumor type, they will be allowed to enroll on the study.\n4. Subjects who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care.\n5. Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded \\[FFPE\\] sample). If no archived tumor tissue is available, we request to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable or unwilling to undergo a pretreatment tumor biopsy due to extenuating circumstances (i.e., cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement with sponsor.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n7. Minimum life expectancy of 12 weeks.\n8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n9. Measurable lesions as defined per RECIST 1.1 within 28 days prior to the first dose of tarlatamab.\n10. Eligible for external beam radiation therapy to a previously unirradiated, measurable lesion as per standard of care.\n\n    1. For the concurrent \u002F sequential cohort of extracranial RT sites:\n\n    i. A minimum of 10 subjects with thoracic lesions (lung, mediastinum, thoracic spine, rib, or other thoracic sites) will be treated ii. Subjects with treated brain metastases are eligible (untreated brain metastases are ineligible) provided they meet the following criteria:\n\n\u003C!-- -->\n\n1. Definitive therapy was completed at least 2 weeks prior to the first dose of tarlatamab.\n2. There is no evidence of radiographic central nervous system (CNS) progression following therapy and by the time of study screening.\n3. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means.\n4. Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.\n\n   b. For the concurrent\u002Fsequential cohort of cranial RT sites: i. Previously untreated brain lesions \u002F metastases are eligible ii. Subjects with previously irradiated brain lesions are eligible provided they meet one of the following criteria:\n\n\u003C!-- -->\n\n1. Prior PCI or whole brain radiation therapy per standard of care with new and\u002For recurrent brain metastases to be treated with SRS or hfSRT\n2. Prior course(s) of SRS or hfSRT or other localized therapy with new lesion(s) to be treated with whole brain radiation therapy iii. Whole brain re-irradiation will be ineligible iv. Re-irradiation with SRS or hfSRT of previously irradiated lesion with SRS or hfSRT will be ineligible v. Craniospinal irradiation will not be allowed c. For the tarlatamab monotherapy cohort: i. Patient must have at least one measurable lesion, however that lesion does not need to be amenable to RT\n\n1\\. Patients with previously irradiated lesions that have recurred or progressed are eligible 11. Adequate organ function, defined as follows:\n\na. Hematological function: i. Absolute neutrophil count ≥ 1.5 x 109\u002FL ii. Platelet count ≥ 100 x 109\u002FL iii. Hemoglobin \\> 9 g\u002FdL (90 g\u002FL) b. Coagulation function: i. Prothrombin time (PT)\u002Finternational normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor.\n\nc. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation \\> 30 mL\u002Fmin\u002F1.73 m2 d. hepatic function: i. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\\u003C 3 x ULN (or \\\u003C 5 x ULN for subjects with liver involvement) ii. Total bilirubin \\\u003C 1.5 x ULN (or \\\u003C 2 x ULN for subjects with liver metastases) e. Pulmonary function: i. No clinically significant pleural effusion ii. Baseline oxygen saturation \\> 90% on room air f. cardiac function (if obtained as part of standard of care): i. Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings\n\nExclusion Criteria:\n\nRe-irradiation, unless it is SRS\u002FhfSRT after whole-brain radiation therapy (WBRT) or PCI or WBRT after SRS\u002FhfSRT; re-irradiation of same lesion, unless verified with the Principal Investigator; patients with lesions not amenable to RT (including previously irradiated) will be only allowable on the tarlatamab monotherapy cohort.\n\nDisease Related\n\n1. Subjects are excluded from the study if any of the following criteria apply:\n\n   1. No lesion(s)\u002Fsite(s) amenable to radiation therapy (only eligible for tarlatamab monotherapy if open)\n   2. Planned re-irradiation of a previously irradiated site\n   3. Leptomeningeal disease requiring craniospinal irradiation\n2. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n3. Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n4. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \\> 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.\n\nOther Medical Conditions\n\n1. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months of first dose of tarlatamab.\n2. History of arterial thrombosis (i.e., stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.\n3. Subject with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.\n\n   NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis and have no clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for \\> 48 hours.\n4. History of hypophysitis or pituitary dysfunction.\n5. Exclusion of hepatitis infection based on the following results and\u002For criteria:\n\n   a. Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).\n\n   b. Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.\n\n   c. Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.\n6. Major surgery requiring hospitalization for more than 3 days within 28 days of first dose of tarlatamab.\n7. Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n8. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n9. Human immunodeficiency virus (HIV) infection.\n\n   1. Subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines.\n\nPrior\u002FConcomitant Therapy\n\n1. Subject received prior therapy with tarlatamab.\n2. Prior anti-cancer therapy within 30 days prior to first dose of tarlatamab.\n\n   Exceptions:\n\n   a. Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1.\n3. Has a diagnosis of immunodeficiency (i.e., positive\u002Fnon-negative test for human immunodeficiency virus) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.\n4. The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:\n\n   1. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study.\n   2. Live viral non-replicating vaccine (i.e., Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care (SOC) and institutional guidelines.\n   3. End of study treatment: Live and live-attenuated vaccines can be used when at least 60 days (5 x half-life of tarlatamab) have passed after the last dose of tarlatamab.\n\nOther Exclusions\n\n1\\. Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab. Contraception methods for female subjects include:\n\n1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)\n2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable)\n3. Intrauterine device\n4. Intrauterine hormonal-releasing system\n5. Bilateral tubal ligation\u002Focclusion\n6. Vasectomized partner (provided that partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success)\n7. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments; the reliability of sexual abstinence must be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject) 2. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.\n\n   3\\. Female subjects planning to become pregnant while on study through 60 days after the last dose of tarlatamab.\n\n   4\\. Female subjects of childbearing potential with a positive pregnancy test assessed at screening and\u002For day 1 by a highly sensitive urine or serum pregnancy test.\n\n   5\\. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception (use a condom) during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   6\\. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   7\\. Male subjects unwilling to abstain from donating sperm during treatment and for an 60 days after the last dose of tarlatamab.\n\n   8\\. Subject has known sensitivity to any of the products or components to be administered during dosing.\n\n   9\\. Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n\n   10\\. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.","ALL","18 Years","99 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites.\n\nI) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting.\n\nIII) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT.\n\nA nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.",[29,30,31,32,33,34,35,36,37,38,39],"Melanoma","Medullary Thyroid Cancer","Sinonasal Undifferentiated Carcinoma","Esthesioneuroblastoma","Bladder Cancer","Testicular Cancer","Glioblastoma Multiforme","Cervical Cancer","Large Cell Neuroendocrine Carcinoma of the Lung","Non Small Cell Lung Cancer","Merkel Cell Carcinoma",[41],"DLL3 Expressing tumors","RECRUITING","2026-05-19",{"date":45,"type":46},"2026-05-20","ACTUAL",{"date":48,"type":46},"2025-09-08",{"date":50,"type":22},"2030-05",{"name":52,"class":53},"University of Arizona","OTHER",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100510365","phase-2-pembrolizumab-in-locally-advanced-sinonasal-carcinoma-100510365","NCT05925491","Pembrolizumab in Locally Advanced Sinonasal Carcinoma","Neoadjuvant Pembrolizumab Plus Chemotherapy in Locally Advanced Sinonasal Carcinoma","NeoPeSino","Inclusion Criteria:\n\n1. Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies.\n2. Have locally advanced disease defined as stage III of IV a-b according to American Joint Committee on Cancer (AJCC) cancer staging system VIII edition.\n3. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.\n4. Be ≥ 18 years of age on day of signing informed consent.\n5. Have measurable disease based on RECIST 1.1 as determined by the site.\n6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n7. Demonstrate adequate organ function.\n8. A male participant must agree to use contraception during the treatment period and for at least 180 days after last dose, corresponding to time needed to eliminate any study treatments plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity. He must refrain from donating sperm during this period, too.\n9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   o Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees use contraception during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatments plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.\n10. Have provided tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).\n2. 2\\. Have metastatic disease defined as stage IV c according to AJCC cancer staging system VIII edition.\n3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n4. 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).\n5. Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.\n6. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.\n7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n8. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n9. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ (eg, breast carcinoma or cervical cancer in situ that have undergone potentially curative therapy are not excluded\n10. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n11. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n12. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n13. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n14. Has an active infection requiring systemic therapy.\n15. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n16. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA qualitative is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n17. Has a known history of active TB (Bacillus Tuberculosis).\n18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n21. Has had an allogenic tissue\u002Fsolid organ transplant",{"count":64,"type":22},28,[26],"This study will test the Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced sinonasal undifferentiated carcinoma (SNUC).\n\nActivity of neoadjuvant chemotherapy in locally advanced SNUC has been already demonstrated; the primary hypothesis is that the addition of pembrolizumab as neoadjuvant and adjuvant agent might confirm the results obtained with a combined treatment strategy including chemotherapy, decreasing the burden of treatment-related side effects.",[31],[31,69,70,71,72,73,74],"SNUC","neoadjuvant immunotherapy","neoadjuvant treatment","locally advanced","pembrolizumab","neoadjuvant","2026-04-15",{"date":77,"type":46},"2026-04-16",{"date":79,"type":46},"2024-12-24",{"date":81,"type":22},"2027-12",{"name":83,"class":53},"Istituti Clinici Scientifici Maugeri SpA",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":54},"100588344","phase-2-toripalimab-with-chemotherapy-for-sinus-cancer-100588344","NCT06940180","Toripalimab With Chemotherapy for Sinus Cancer","Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally advanced nasal cavity or paranasal sinus cancer including the following histologic subtypes: squamous cell carcinoma (SCC) of any morphologic variation: verrucous, papillary, basaloid, spindle cell, and adenosquamous; or sinonasal undifferentiated carcinoma (SNUC).\n* Participants with SCC should have resectable disease at baseline per the discretion of the treating surgical oncologist(s). \\*Participants with SNUC can have operable or borderline resectable (definition: resection would been morbid requiring extensive surgery and would have chances of incomplete gross total resection) disease as judged by the treating surgical oncologist(s).\n* Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T2, N1-3 III\n  * T3, any N III, IVA, IVB\n  * T4, any N IVA, IVB\n* Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1000\u002FmcL\n  * Platelets ≥100\n  * Total bilirubin ≤institutional upper limit of normal (ULN)\n  * AST(SGOT) \u002F ALT (SGPT) ≤3x ULN\n  * Creatinine ≤institutional ULN or GFR of ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2\n* Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception use should be maintained until at least 6 months after the last dose of chemotherapy for females and 3 months for males. In addition, contraception use should continue until 4 months after last dose of toripalimab for both males and females.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with nasal cavity or paranasal sinus malignancies demonstrating histologies other than SCC or SNUC in the opinion of the reviewing pathologist. Excluded subtypes include: angiosarcomas, rhabdomyosarcomas, lymphomas, olfactory neuroblastomas (esthesioneuroblastomas), melanomas, and meningiomas among others. SNEC or sinonasal neuroendocrine carcinoma is not permitted.\n* Participants with unresectable or inoperable disease as judged by the treating surgical oncologist(s).\n* Participants with known distant metastatic disease (M1 or IVC).\n* Has received prior therapy with an anti-PD-1\u002FL1 agent or any other agent directed to another stimulatory or co-inhibitory T-cell receptor.\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Non-live vaccines are permitted.\n* Carries a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Exceptions may be permitted at the discretion of the overall Sponsor-Investigator.\n* Has an active autoimmune disease that has required systemic treatment in past 6 months (with use of a disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.\n* Has a history of (non-infectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease.\n* Has a known history of human immunodeficiency virus (HIV) infection that is uncontrolled. No HIV testing is required unless mandated by local health authority. Patients with well controlled HIV may be eligible if their CD4 T cell count is favorable and their HIV viral load is undetectable.\n* Has a known history of active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history of allogeneic tissue or solid organ transplant.\n* Women who are pregnant or breastfeeding.",{"count":93,"type":22},20,[26],"The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers.\n\nThe names of the study drugs used in this research study are:\n\n* Toripalimab (a type of monoclonal antibody)\n* Carboplatin (a type of antineoplastic agent)\n* Docetaxel (a type of antineoplastic agent)\n* Cisplatin (a type of antineoplastic agent)",[97,98,99,31,100],"Sinonasal Cancer","Paranasal Sinus Neoplasms","Squamous Cell Carcinoma","Locally Advanced Head and Neck Cancer",[102,99,31,100,103,104,97],"Paranasal Sinus Neoplasm","Advanced Sinonasal Cancer","Advanced Paranasal Sinus Cancer","2025-06-25",{"date":107,"type":46},"2025-06-26",{"date":109,"type":46},"2025-06-17",{"date":111,"type":22},"2029-02-01",{"name":113,"class":53},"Glenn J. Hanna"]