[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nasopharynx-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nasopharynx-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,79,106,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":45},"100642704","phase-1-a-study-of-cemiplimab-and-fianlimab-in-people-with-nasopharyngeal-carcinoma-100642704",false,"NCT07650266","A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma","A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18\n* Pathologically (histologically or cytologically) proven (from primary lesion and\u002For lymph node) diagnosis of non-keratinizing nasopharynx carcinoma\n* Pathologic confirmation of EBV status in biopsy sample. EBER (Epstein-Barr virus-encoded RNA) detection via immunohistochemistry or in situ hybridization or polymerase chain reaction, collected as routine clinical standard to determine EBV status.\n* Patient must be seen by head and neck surgery, radiation oncology, medical oncology, as standard of care which includes standard nasopharyngoscopy. All three disciplines need to agree that the patient is eligible. Note: Nasopharyngoscopy does not need to be repeated by all three disciplines. This test is often only performed by head and neck surgery and\u002For radiation oncology.\n* AJCC 8th edition: T1N1, T2N0-1, T1-T2N2 nasopharynx carcinoma\n* ECOG performance status 0-1\n* Adequate organ and bone marrow function documented by:\n\n  * Hemoglobin \\> 9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) \\>1.5 x 109 \u002FL\n  * Platelet count \\>100 x 109 \u002FL\n  * Adequate renal function: Serum creatinine \\\u003C1.5 mg\u002FdL or creatinine clearance ≥ 50 ml\u002Fmin determined by 24-hour urine collection or estimated by Cockcroft-Gault formula\n  * Adequate hepatic function: - T bili \\\u003C1.5x ULN, AST or ALT \\\u003C 1.5 ULN, Alkaline phosphatase \\\u003C1.5 x ULN). Note: for patients with Gilbert Syndrome, total Bilirubin \\\u003C3x ULN.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n* Signed informed consent form by the participant.\n\nExclusion Criteria:\n\n\\- Evidence of distant metastatic disease by radiographic imaging. Equivocal findings are subject to P.I. and Co-PI approval\n\n* Prior head and neck radiation (Exceptions can be made if the overlap regions are minimal and must be approved by PI\u002FCo-PI)\n* Grade ≥2 hearing loss\n* Grade ≥2 peripheral sensory neuropathy\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater\n\n  o Note: Exceptions can be made for patients with prior or concurrent invasive malignancy if determined by the PI\u002FCo-PI, then the patient can proceed with protocol activities\n* Prior systemic chemotherapy for the study cancer o Note: prior chemotherapy for a different cancer is allowable, must check with PI\u002FCo-PI\n* Severe, active co-morbidity defined as follows:\n\n  o Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics treatment within 2 weeks prior to the first dose of trial medication\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.\n* Participants with a history of myocarditis.\n* TnT or troponin I TnI \\> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\> 1 to 2x ULN within 24 hours, the patient may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.\n* History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n* Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n\n  o Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n  * Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n  * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n* Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* Patients using immunosuppressive doses (≥10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study.\n* Received a live vaccine within 30 days of planned start of study medication, during treatment and for 90 days after treatment.\n\n  o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.\n* Woman of child bearing potential (WOCBP)\\* must have a negative serum (beta-hCG) within 14 days prior to registration.\n\n  * \\*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n  * Pregnancy testing and contraception are not required for women who are post-menopausal or permanently sterile.\n  * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation\n  * Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence†\n  * Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n  * Periodic abstinence‡, withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n* WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment\n* All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose\n* Pregnant or breastfeeding women. o WOCBP who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include: i. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; ii. intrauterine device; intrauterine hormone-releasing system; iii. bilateral tubal occlusion\u002Fligation; iv. vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For v. sexual abstinence† ‡\n\n  * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.\n\n    * Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to find out whether cemiplimab, with or without fianlimab, is an effective treatment for advanced nasopharyngeal carcinoma (NPC), when given with standard chemotherapy drugs gemcitabine and cisplatin before standard chemoradiation.",[26,27,28,29],"Nasopharyngeal Carcinoma","Nasopharyngeal Cancer","Nasopharynx Carcinoma","Nasopharynx Cancer",[26,27,28,29,31,32,33],"Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma","Memorial Sloan Kettering Cancer Center","26-172","NOT_YET_RECRUITING","2026-06-10",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":20},"2026-07",{"date":42,"type":20},"2030-07",{"name":32,"class":44},"OTHER",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100476395","the-head-and-neck-registry-of-the-european-reference-network-on-rare-adult-solid-cancers-100476395","NCT05483374","The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers","The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers","EURACAN","Inclusion Criteria:\n\n* Patients with epithelial tumours of nasopharynx; nasal cavity and paranasal sinuses; salivary gland cancer in large and small salivary glands; and middle ear (i.e. squamous carcinoma; adenocarcinoma; neuroendocrine; adenosquamous carcinoma, teratocarcinosarcoma, NUT carcinoma, odontogenic tumors) + neuroendocrine and adenocarcinoma in hypopharynx; oropharynx; larynx; oral cavity and lip + odontogenic carcinoma in oral cavity.\n* Adult patients (aged ≥18 years).\n* Diagnosis performed or verified by the expert centre entering the patient information in the registry.\n* Patients entering the HCP at any clinical phase of the disease (diagnosis, treatment of primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP can decide, based on its resources, the number of patients on whom it can collect data.\n* New patients managed by the HCP from 2021 onwards plus patients managed by the HCP, who are actively followed up at the hospital, with year of diagnosis dating back to maximum 2018.\n\nExclusion Criteria:\n\n• Patients (aged \\\u003C 18 years)",{"count":55,"type":20},13600,"OBSERVATIONAL","Cancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care.\n\nThe registry is a prospective observational real-world registry. It collects data from already available registries\u002Fdatabase and\u002For directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https:\u002F\u002Feuracan.eu\u002Fresearch\u002Fstarter\u002Frare-head-and-neck-cancer-registry\u002F#codebook).\n\nThe registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients' and cancers' variables; analytical analyses investigating the association of patients\u002Fdisease and\u002For treatment characteristics and health outcomes.\n\nFondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients' personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016\u002F679 of the EU.",[59,29,60,61,62],"Head and Neck Cancer","Nasal Cavity and Paranasal Sinus Cancer","Salivary Gland Cancer","Middle Ear Carcinoma",[64,65,66,67],"Rare cancers","head and neck cancers","registry","protocol","RECRUITING","2026-03-30",{"date":71,"type":38},"2026-04-03",{"date":73,"type":38},"2022-05-31",{"date":75,"type":20},"2030-12-31",{"name":77,"class":44},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",10,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100563324","phase-1-u87-car-t-in-patients-with-advanced-head-and-neck-tumors-100563324","NCT06614686","U87 CAR-T in Patients With Advanced Head and Neck Tumors","A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors","Inclusion Criteria:\n\n1. Subjects have provided informed consent, understanding the study\\'s risks and benefits, and are willing to complete the study procedures.\n2. Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.\n3. ECOG performance status of 0-1.\n4. Anticipated survival of at least 12 weeks.\n5. Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available\n6. Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.\n7. At least one measurable tumor lesion according to RECIST 1.1.\n8. Suitable venous access for mononuclear cell collection.\n9. Adequate major organ function.\n10. Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. Inadequate washout period from prior anti-cancer treatments before leukapheresis.\n2. Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.\n3. Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.\n4. Previous Trop2-targeted CAR-T\u002FTCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.\n5. Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.\n6. Active infection requiring intravenous anti-infective therapy.\n7. Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.\n8. Primary immunodeficiency or active autoimmune disease.\n9. Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.\n10. Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.\n11. History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.\n12. Allergy to protein drugs or multiple medications.\n13. Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell\u002Forgan transplantation. Uncontrollable third-space fluid accumulation.\n14. Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.\n\n    Pregnant or breastfeeding women.\n15. Uncontrollable psychiatric history.\n16. Other conditions deemed unsuitable for study participation by the investigator.","70 Years",{"count":88,"type":20},20,[23],"This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.",[29,59],[93,94],"Chimeric Antigen Receptor T Cell","U87","2024-09-25",{"date":97,"type":38},"2024-09-26",{"date":99,"type":20},"2024-09-20",{"date":101,"type":20},"2027-12-31",{"name":103,"class":104},"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd","INDUSTRY",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100563104","phase-2-gep-combined-with-radiotherapy-in-non-locally-treatable-recurrent-npc-100563104","NCT06611826","GEP Combined With Radiotherapy in Non-locally Treatable Recurrent NPC","A Prospective, Single-arm Phase II Clinical Study of GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy in Non-locally Treatable Recurrent Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Patients aged ≥18 years;\n2. ECOG performance status 0-2;\n3. Pathological or clinical imaging diagnosis of recurrent nasopharyngeal carcinoma;\n4. With imaging assessable lesions (assessed by RECIST 1.1 criteria);\n5. Recurrent lesions are not eligible for curative local treatment (including but not limited to extensive invasion of recurrent lesions; recurrent lesions with obvious necrosis or ulceration, with bleeding risk; recurrent lesions extensively invading surrounding nerves\u002Fvessels or skin\u002Fmuscle; obvious late radiation therapy complications after previous treatment: radiation-induced brain injury, posterior cranial nerve injury, dysphagia, severe myofibrosis; second or multiple courses of radiation therapy after recurrence or multiple recurrences);\n6. The following requirements must be met for the function of major organs:\n\n   Hematological parameters tolerable to treatment: white blood cells ≥3.0×10\\^9\u002FL, neutrophils ≥1.5×10\\^9\u002FL, hemoglobin ≥9 g\u002FdL, platelets ≥90×10\\^9\u002FL.\n\n   Liver and kidney function: ALT, AST \\\u003C1.5 times the upper limit of normal (ULN), total bilirubin \\\u003C1.5×ULN, serum creatinine (Cr) ≤1.5×ULN; Echocardiographic assessment, left ventricular EF ≥50%;\n7. The patient has signed an informed consent form and is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other research procedures.\n8. Voluntarily enroll in this study, sign an informed consent form, have good compliance and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Subjects who cannot accept or tolerate chemotherapy or radiotherapy for various reasons;\n2. Subjects who can be cured by definitive radiotherapy or surgery;\n3. Subjects who have undergone major surgical procedures within the past 4 weeks or have not fully recovered from such procedures;\n4. Subjects who are currently participating in other drug clinical trials;\n5. Serious cardiac disease or discomfort, including but not limited to the following conditions:\n\n   * History of congestive heart failure or impaired systolic function (LVEF \\\u003C50%);\n   * Uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate \\>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular conduction block (i.e., Mobitz Ⅱ second-degree atrioventricular conduction block or third-degree atrioventricular conduction block);\n   * Angina requiring anti-angina drug therapy;\n   * Clinically significant valvular heart disease;\n   * ECG showing a penetrating myocardial infarction;\n   * Uncontrolled hypertension (systolic blood pressure \\>180mmHg and\u002For diastolic blood pressure \\>100mmHg);\n6. Subjects who have a history of hypersensitivity to any component of the study drug;\n7. Any other situation in which the investigator deems the subject unsuitable to participate in the study.",{"count":114,"type":20},41,[116],"PHASE2","This research aims to assess both effectiveness and safety of combining R-GEP regimen comprising gemcitabine, recombinant human endostatin, and cerexinib with low- and high-dose radiotherapy in managing unresectable recurrent nasopharyngeal carcinoma.",[29],"2024-09-24",{"date":95,"type":38},{"date":122,"type":20},"2024-09-30",{"date":124,"type":20},"2029-12-30",{"name":126,"class":44},"Zhejiang Cancer Hospital",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100517560","phase-2-nivolumab-in-children-and-adults-with-nasopharyngeal-carcinoma-100517560","NCT06019130","Nivolumab in Children and Adults With Nasopharyngeal Carcinoma","Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma","NPC-Nivo","Inclusion Criteria:\n\n1. Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged between 3 years and 17 years, OR histologically confirmed new diagnosis of EBV-positive nasopharyngeal carcinoma, WHO stage II or III, in subjects ≥ 18 years\n2. Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients \\> 25 years of age (AJCC, 8th edition)\n3. Measurable disease by MRI per RECIST 1.1 criteria\n4. Sufficient tumor tissue to be sent for central review, including PD-L1 staining, either as 1 or 2 full blocks (preferred) or a minimum of 25 slides, obtained from core biopsy, punch biopsy, excisional biopsy or surgical specimen\n5. Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation\n\nExclusion Criteria:\n\n1. Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients \\> 25 years of age\n2. Recurrent nasopharyngeal carcinoma\n3. Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and\u002For radiotherapy\n4. Prior chemotherapy and\u002For radiotherapy\n5. Other active malignancy\n6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n7. The subject received an investigational drug within 30 days prior to inclusion into this study\n8. Subjects who are enrolled in another clinical trial\n9. Subjects with prior organ allograft or allogenic bone marrow transplantation\n10. Subjects with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.\n11. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before start of therapy. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n12. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n13. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n14. Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values:\n\n    1. WBC \\\u003C 2 000\u002Fµl\n    2. Neutrophils \\\u003C 1 500\u002Fµl\n    3. Platelets \\\u003C 100 x 10e3\u002FµL\n    4. Hemoglobin \\\u003C 9.0 g\u002FdL\n    5. Creatinine \\>1.5 x ULN or creatinine clearance \\\u003C 50 mL\u002Fmin (using the Cockcroft Gault formula or Schwartz formula in patients \\\u003C 18 years)\n    6. AST\u002FALT \\> 3 x ULN (\\> 5 x ULN if liver metastases)\n    7. Total Bilirubin \\> 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 x ULN)\n15. Hearing loss \\> 20 dB loss at 3 kHz due to an inner ear disorder and not caused by tumour burden\n16. History of allergy or hypersensitivity to platinum-containing compounds or other study drug components\n17. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).\n18. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug.\n19. Adequate performance status (Karnofsky score ≥ 60 for patients (age ≥ 16), Lansky score ≥ 60 (age \\\u003C 16).\n20. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.\n21. The subject has any current or past medical condition and\u002For required medication to treat a condition that could affect the evaluation of the study.\n22. Pregnant females as determined by positive \\[serum or urine\\] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol. (Please refer to section 4.4)\n23. Lactating females\n24. Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities\n25. The subject is unwilling or unable to follow the procedures outlined in the protocol\n26. The subject is mentally or legally incapacitated.","3 Years",{"count":137,"type":20},57,[116],"The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.",[26,27,141,29],"Nasopharyngeal Neoplasms",[143,144,145,146,147,148],"Immunotherapy","Nivolumab","Children","Adults","Chemotherapy","Immune Checkpoint Inhibitor","2024-05-14",{"date":151,"type":38},"2024-05-16",{"date":153,"type":38},"2023-01-10",{"date":155,"type":20},"2028-01-09",{"name":157,"class":44},"German Society for Pediatric Oncology and Hematology GPOH gGmbH",31]