[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-cavity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-cavity":132},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,80],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100643980",false,"NCT07667296","APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Open-Label Phase 3 Study of APG-157 as Neoadjuvant Therapy or as Induction and Maintenance Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria\n\nCohort A (Resectable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity or oropharynx.\n3. Resectable disease appropriate for curative-intent surgery.\n4. Stage III-IVA disease according to AJCC criteria:\n\n   * Oropharynx, p16-positive: Stage III (T4, N0-N3, M0)\n   * Oropharynx, p16-negative: Stage III or IVa (T3-T4, N0-N2, M0)\n   * Oral cavity: Stage III or IVa (T3-T4, N0-N2, M0)\n5. Objectively medically ineligible for perioperative pembrolizumab according to protocol-defined objective criteria.\n6. HPV\u002Fp16 testing available for stratification.\n7. Measurable or evaluable disease.\n8. Life expectancy ≥12 months.\n9. ECOG Performance Status ≤2.\n10. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.\n11. Ability to comply with study procedures.\n\nCohort B (Unresectable \u002F Medically Inoperable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated LA-HNSCC of the oropharynx. Disease not suitable for curative-intent surgery.\n3. Stage III-IVA disease according to AJCC criteria:\n\n   * p16-positive Stage III (T4, N0-N3, M0) with \\>10 pack-year smoking history\n   * p16-negative Stage III or IVa (T3-T4, N0-N2, M0)\n4. HPV\u002Fp16 testing available for stratification.\n5. Presence of evaluable tumor burden.\n6. Eligible to receive definitive chemoradiotherapy.\n7. Life expectancy ≥12 months.\n8. ECOG Performance Status ≤2.\n9. Adequate organ function.\n10. Contraception requirements met.\n11. Ability to comply with study procedures.\n\nExclusion Criteria\n\nCohort A Specific:\n\n* Stage I-II disease\n* Stage IVb or Ivc disease\n* T4b unresectable disease\n* N3 disease where applicable\n* Medically eligible for perioperative pembrolizumab\n\nCohort B Specific:\n\n* Stage I-II disease\n* Disease not appropriate for curative-intent CRT\n* Active autoimmune disease requiring systemic therapy\n* Prior solid organ or allogeneic stem cell transplant\n* Ongoing immunosuppression \\>10 mg\u002Fday prednisone equivalent\n\nCommon Exclusion Criteria:\n\n* Primary tumor arising from the nasopharynx, hypopharynx, larynx, paranasal sinus, or unknown primary site.\n* Prior treatment for current head and neck squamous cell carcinoma.\n* Prior malignancy unless protocol exceptions met\n* Distant metastatic disease\n* Live vaccine within 30 days\n* Known hypersensitivity to APG-157 or its components.\n* Unresolved clinically significant toxicity\n* Recent participation in another investigational study\n* Active uncontrolled infection\n* Significant uncontrolled cardiovascular disease\n* Pregnancy or breastfeeding.\n* QTcF \\>500 msec or congenital long QT syndrome\n* Any condition compromising safety, compliance, or study interpretation\n\nRandomization ratio: 1:1 within each cohort\n\nStratification Factors:\n\nCohort A:\n\n* HPV\u002Fp16 status,\n* Planned platinum strategy,\n* PD-L1 CPS category\n\nCohort B:\n\n* HPV\u002Fp16 status\n* Planned platinum strategy\n* Geographic region.","ALL","18 Years",{"count":18,"type":19},826,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This Phase 3, multicenter, randomized, open-label study evaluates APG-157 in adults with newly diagnosed locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Two independently powered cohorts are enrolled based on treatment pathway. Cohort A evaluates APG-157 administered as neoadjuvant therapy before curative-intent surgery in participants with resectable oral cavity or oropharyngeal cancer who are medically ineligible for perioperative pembrolizumab. Cohort B evaluates APG-157 administered as induction therapy before definitive chemoradiotherapy and as maintenance therapy after chemoradiotherapy in participants with unresectable or medically inoperable disease. Participants are randomized 1:1 within each cohort to receive APG-157-based treatment or standard-of-care therapy. The primary hypothesis is that APG-157 given before definitive surgery followed by (chemo)radiotherapy improves event-free survival (EFS) compared to surgery and adjuvant (chemo)radiotherapy alone (Cohort A), and that APG-157 given as induction therapy prior to definitive chemoradiotherapy (CRT) followed by maintenance APG-157 improves EFS compared to definitive CRT alone (Cohort B).",[25,26,27,28,29,30,31],"Head and Neck Cancer","Head and Neck (HNSCC)","Oropharyngeal","Oral Cavity","Oral Cavity Carcinoma","Oropharynx Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":19},"2026-07",{"date":40,"type":19},"2032-12",{"name":42,"class":43},"Aveta Biomics, Inc.","INDUSTRY",{"id":45,"slug":4,"hasResults":10,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100447298","NCT05104619","Spectroscopic Analysis of Tongue Tumor Samples.","Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy","SpecTum","Inclusion Criteria:\n\n* age : 18 years and older\n* squamous cell carcinoma of the tongue\n* surgical resection as first-line treatment\n* tumor classification T1 to T4.\n\nExclusion Criteria:\n\n* metastatic disease\n* neoadjuvant therapies",{"count":52,"type":19},33,"OBSERVATIONAL","In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.\n\nTechniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.\n\nBased on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.",[56,57,58,59,28,60],"Mass Spectroscopy","Molecular Profile","Surgical Margins","Squamous Cell Carcinoma","Tongue",[62,63,64,65,66,67],"mass spectroscopy","molecular profile","surgical margins","squamous cell carcinoma","oral cavity","tongue","RECRUITING","2026-06-12",{"date":71,"type":36},"2026-06-15",{"date":73,"type":36},"2021-03-10",{"date":75,"type":19},"2026-10",{"name":77,"class":78},"Centre Hospitalier Universitaire, Amiens","OTHER",1,{"id":81,"slug":4,"hasResults":10,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":20,"phases":88,"briefSummary":90,"conditions":91,"keywords":102,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":79},"100572677","NCT06736379","Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer","Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer","Inclusion Criteria:\n\n1. Cohort A - Unresectable or recurrent\u002Fmetastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:\n\n   Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.\n\n   Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n\n   Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).\n\n   Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n\n   Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, therefore these subjects must have been previously treated with an applicable tyrosine kinase inhibitor.\n\n   OR Cohort C - Patients with at least 1 measurable resectable lesion clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition) (Amin, 2017), Histologically or cytologically confirmed HNSCC. Scheduled to undergo tumor surgical resection of the primary tumor.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.\n3. Primary tumors should be amenable to intratumoral (IT) injection \\>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.\n4. Subjects with either a local recurrence or a new primary tumor will be allowed.\n5. Age ≥ 18 years.\n6. Have acceptable organ and marrow function defined as follows:\n\n   Absolute neutrophil count ≥ 1,500\u002FmcL Platelets ≥ 100,000\u002FmcL Hemoglobin ≥ 8.0 g\u002FdL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN\n7. Ability to understand and the willingness to provide written informed consent.\n8. Life expectancy \\> 12 weeks (about 3 months).\n9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.\n2. Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and\u002For urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.\n3. Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.\n4. Participation in another clinical study with an investigational product during the last 30 days.\n5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.\n6. Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone or an equivalent corticosteroid.\n7. If applicable: Women who are breastfeeding.\n8. History of allogenic organ transplant that requires use of immunosuppressives.\n9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.\n10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention.\n12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.",{"count":87,"type":19},41,[89],"PHASE1","The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are:\n\nThe safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01)\n\nThe tumor response to IT injections of VLPONC-01\n\nThe tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment\n\nResearchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.",[92,25,93,94,95,96,97,98,99,100,101,28,29],"Head and Neck Cancers- Squamous Cell","Solid Tumors","HNSCC","SCC - Squamous Cell Carcinoma","SCCHN","Head Neck Cancer","Head and Neck Squamous Cell Cancer","Squamous Cell Carcinoma of the Head and Neck","Squamous Cell Carcinoma, Head And Neck","Squamous Cell Head and Neck Carcinoma",[103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122],"Virus-like particle","VLP","IL-12","Interleukin 12","Intratumoral","VRP","Viral Replicon Particle","saRNA","VRP-encapsulated","IT injection","pembrolizumab","anti-PD-1","tumor resection surgery","tumor resection","Self-amplifying RNA","Multiple inoculations directly into the tumor","Keytruda","viral particles per injection","viral particles","macrophage","2026-01-15",{"date":125,"type":36},"2026-01-20",{"date":127,"type":36},"2025-05-13",{"date":129,"type":19},"2027-12-30",{"name":131,"class":43},"VLP Therapeutics",""]