[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,59,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100628371","phase-1-safety-and-feasibility-of-nivolumab-irdye800cw-in-patients-with-head-and-neck-squamous-cell-carcinoma-hnscc-100628371",false,"NCT07460765","Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.\n* Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n\nExclusion Criteria:\n\n* Patients not planning for SOC surgical resection\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n     1. Rash must cover \\\u003C 10% of body surface area\n     2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n     3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n* History of hepatitis C that has not been treated with curative intent.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n* Prior allogeneic stem cell or solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n  1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n  2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if \\>30 days from first infusion.\n  4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n* Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.",[25,26,27,28,29,30,31,32,33,34,35],"Hnscc","Head and Neck","Squamous Cell Cancer","Squamous Carcinoma","Squamous Cell Cancer of Head and Neck (SCCHN)","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma Mouth","Squamous Carcinoma Poorly Differentiated","Squamous Cell Cancer of the Head and Neck","Squamous Cell Carcinoma (SCC) of the Oral Cavity","Squamous Cell Carcinoma (SCC)",[37,38,39,40,41,42,43,44,45],"nivo800","neoadjuvant","surgery","head and neck cancer","head and neck","surgical resection","oral cancer","SCC","HNSCC","RECRUITING","2026-06-26",{"date":49,"type":50},"2026-06-30","ACTUAL",{"date":52,"type":19},"2026-07",{"date":54,"type":19},"2031-04",{"name":56,"class":57},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":20,"phases":68,"briefSummary":69,"conditions":70,"keywords":84,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100628495","phase-1-a-phase-1-study-of-epi-326-in-egfr-mutant-nsclc-and-hnscc-100628495","NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.",{"count":67,"type":19},110,[22],"A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[71,72,73,74,75,76,26,77,78,79,80,81,82,45,83],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Non Small Cell Lung Cancer","Head and Neck Cancer","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","NSCLC (Non-small Cell Lung Cancer)","EGFR",[80,45,73,83,76,85],"NSCLC","2026-06-08",{"date":88,"type":50},"2026-06-10",{"date":90,"type":50},"2026-03-31",{"date":92,"type":19},"2029-07",{"name":94,"class":95},"EpiBiologics","INDUSTRY",6,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":20,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":121,"locationsCount":123},"100611491","spect-ct-guided-elective-contralateral-neck-treatment-in-lateralized-oropharyngeal-cancer-100611491","NCT07241273","SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer","SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer: A Phase II Trial","SELECT-FR","Inclusion Criteria:\n\n1. Patients must have signed a written informed consent form prior to any trial specific procedures.\n2. Patients with histologically confirmed T1-T3 M0 lateralized OPC (tonsil, soft palate, pharyngeal wall or base of tongue) not involving or crossing midline. Nodal disease may include no node or single or multiple ipsilateral lymph nodes (largest should be equal or less than 6 cm in maximum diameter) without contralateral nodes involved. For HPV-positive patients, this includes N0-N1. For HPV-negative patients, this includes N0-N2b. Patients with radiologic extranodal extension without clinical signs of extranodal extension (skin invasion, deep nodal fixation, and\u002For clinical signs of cranial nerve or brachial plexus invasion) will be eligible for participation.\n3. HPV-positive or -negative (by p16 immunohistochemistry). Tumours will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.\n4. Planned definitive bilateral neck radiotherapy with or without concurrent chemotherapy.\n5. Patients ≥ 18 years old.\n6. ECOG Performance Status 0-1.\n7. The following radiological investigations must have been done within 8 weeks before randomization:\n\n   * CT or MRI of the neck (with head imaging as indicated);\n   * PET-CT scan;\n   * Chest CT scan.\n8. Patients who receive a concomitant chemoradiotherapy (cCRT) should have adequate organ and bone marrow function including the following:\n\n   * Hematological function (absolute neutrophil count ≥ 1.5 x10⁹\u002FL, platelets ≥ 100 x10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL) measured before cCRT.\n   * Renal function (creatinine clearance ≥ 50 mL\u002Fmin per Cockcroft and Gault formula) measured before cCRT.\n   * Hepatic function (total bilirubin \\\u003C 1.5 ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C 2.5 ULN, Alkaline phosphatase \\\u003C 2.5 ULN) measured before cCRT.\n9. Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method up to 90 days after completing radiotherapy.\n\n   Women of childbearing potential must have a negative pregnancy test before the beginning of the trial.\n10. Treating surgeon must confirm that the patient is a candidate to undergo injection procedure for lymphatic mapping in either the nuclear medicine, ambulatory clinic, or operating room setting.\n11. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n12. Patients affiliated to (or beneficiary from) the French social security system.\n13. 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 are eligible for this trial.\n\nExclusion Criteria:\n\n1. Patients with T1-T2 cancers isolated to the tonsil fossa (i.e., without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node \\\u003C 3 cm without extranodal extension.\n2. Patients with tonsil or tongue base primary squamous cell carcinoma who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease are excluded. However, patients who have had previous deep biopsies or partial excisions with clinically evaluable disease are still eligible.\n3. Previous head and neck cancer or multiple synchronous primary head and neck cancers.\n4. Previous induction or neo-adjuvant chemotherapy.\n5. Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are, however, still eligible.\n6. Previous radiotracer allergy. Contraindication in patients with history of hypersensitivity to human albumin-containing products.\n7. Patients with severe, active co-morbidity including any of the following:\n\n   * Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration.\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization within the 30 days of registration.\n   * Acute myocardial infarction within 30 days of study registration.\n   * Diseases precluding RT (e.g., scleroderma).\n8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, as assessed by the investigator.\n9. Pregnant or breastfeeding women.\n10. Patient enrolled in another therapeutic trial within 30 days of registration.\n11. Persons deprived of their liberty or under protective custody or guardianship.",{"count":106,"type":19},128,[108],"NA","Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Even though a small proportion of patients with this cancer have involvement of the lymph nodes of the neck on the opposite side of the tumour (contralateral involvement) or involvement of the lymph nodes on both sides of the neck (bilateral involvement), bilateral radiotherapy is performed due to the risk of contralateral microscopic involvement, which is invisible on imaging and clinical examination. Bilateral radiotherapy causes more adverse events, leading to a decrease in quality of life.\n\nLymphatic mapping using Single Photon Emission Computed Tomography-Computed Tomography (SPECT-CT) imaging is a technique that visualises the lymphatic drainage of the tumour and thus determines whether radiotherapy should be delivered unilaterally or bilaterally to the lymph nodes. This technique would therefore reduce adverse events and improve quality of life, while maintaining the efficacy of radiotherapy.\n\nThe goal of the clinical trial SELECT-FR is to investigate if the efficacy of a lymphatic drainage mapping with a SPECT-CT-guided approach is acceptable in terms of two-year Disease Free Survival (DFS) rate in patients with lateralized OPC.",[111,112,113,26,77,78],"Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Cancers","Oropharyngeal Carcinoma","NOT_YET_RECRUITING","2026-03-23",{"date":117,"type":50},"2026-03-24",{"date":119,"type":19},"2026-04",{"date":54,"type":19},{"name":122,"class":57},"UNICANCER",12]