[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oropharyngeal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oropharyngeal-cancer":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,100,127,158,186,215,248,283,311,336,363,383,404,430,458,480,515,539],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":77,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100210159","integrated-cancer-repository-for-cancer-research-100210159",false,"NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"ALL","19 Years","110 Years",{"count":21,"type":22},999999,"ESTIMATED","80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[27,28,78,79,80,81,82,83,84,85,65,86,75,76],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":90,"type":91},"2026-06-29","ACTUAL",{"date":93,"type":91},"2013-11-01",{"date":95,"type":22},"2099-12",{"name":97,"class":98},"University of Nebraska","OTHER",42,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100473908","phase-3-spect-ct-guided-elective-contralateral-neck-treatment-for-patients-with-lateralized-oropharyngeal-cancer-100473908","NCT05451004","SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer","SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial","SELECT","Inclusion Criteria:\n\n* Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline.\n* HPV positive or negative (by p16 immunohistochemistry).\n* Clinical stage T1-3 M0 (UICC\u002FAJCC TNM 8th Edition). Nodal involvement may include no nodes or single or multiple ipsilateral lymph nodes (largest ≤6cm in maximum diameter)\n* Radiological investigations within 8 weeks of registration:\n\n  * CT or MRI of the neck (with head imaging as indicated);\n  * PET-CT scan\n  * Chest CT scan\n* Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded).\n* Intent to deliver concurrent chemotherapy or not must be known at the time of randomization. As this is a pragmatic trial, even patients who are not candidates for systemic therapy will be eligible for participation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Willing to complete the quality of life and\u002For health utility questionnaire, if sufficiently fluent in available language(s).\n* Informed consent prior to registration\n* Accessible for treatment and follow-up.\n* Commencement of definitive RT within 28 days (+ 14 days) of randomization.\n* Injection procedure for lymphatic mapping may be performed in the nuclear medicine, ambulatory clinic, or operating room setting\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method\n* 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* Patient must consent to provision of, and investigator(s) must confirm location and commitment to obtain a representation of formalin fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays\n\nExclusion Criteria:\n\n* 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.\n* Tonsil or tongue base primary cancer who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease\n* Previous head and neck cancer or multiple synchronous primary head and neck cancers\n* Previous induction or neo-adjuvant chemotherapy.\n* 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 eligible\n* Radiotracer allergy\n* 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)","18 Years",{"count":110,"type":22},510,"INTERVENTIONAL",[113],"PHASE3","This study is being done to answer the following question:\n\nIs the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?",[57],"2026-06-08",{"date":118,"type":91},"2026-06-09",{"date":120,"type":91},"2023-02-10",{"date":122,"type":22},"2031-08-30",{"name":124,"class":125},"Canadian Cancer Trials Group","NETWORK",36,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":111,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100573523","phase-1-intratumoral-lidocaine-injection-before-oropharyngeal-cancer-surgery-100573523","NCT06747390","Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery","A Phase I Randomized Controlled Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma","856397","Inclusion Criteria:\n\nPatients 18 years older or more.\n\nHistologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.\n\nClinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).\n\nAny clinical N stage disease (per AJCC 8th Ed).\n\nPatients must be undergoing direct laryngoscopy +\u002F- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.\n\nPatients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.\n\nAbility to understand and the willingness to provide written informed consent.\n\n\\---\n\nExclusion Criteria:\n\nPrior external beam radiation therapy to the head and neck.\n\nPrior chemotherapy for head and neck cancer.\n\nTumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).\n\nPresence of distant metastatic disease.\n\nUncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nKnown history of hypersensitivity to lidocaine or other amide local anesthetics.\n\nPregnant or breastfeeding.",{"count":136,"type":22},30,[138],"PHASE1","Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.",[141,57,142,143],"Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Human Papilloma Virus","Squamous Cell Carcinoma",[145,146,57,142,143,147],"TransOral Robotic Surgery (TORS)","Oropharyngeal Squamous Cell Carcinoma","Lidocaine","2026-05-10",{"date":150,"type":91},"2026-05-12",{"date":152,"type":91},"2025-04-23",{"date":154,"type":22},"2028-11-01",{"name":156,"class":98},"Ryan Carey",1,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":111,"phases":167,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100550287","phase-2-using-circulating-tumor-dna-to-risk-adapt-post-operative-therapy-for-hpv-associated-oropharyngeal-cancer-100550287","NCT06445114","Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer","ULTRA-HPV Using Circulating Tumor DNA to Risk Adapt Post-operative Therapy for HPV Associated Oropharyngeal Cancer","Inclusion Criteria:\n\n* AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx.\n* For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.\n* p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.\n* Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with clinical unknown primary tumors, a patient must undergo both ipsilateral tonsillectomy and base of tongue resection unless the primary is identified clinically or pathologically at the time of surgery. If the primary is identified, then only resection of the primary site is required. If the primary tumor is resected with negative margins with a non-robotic surgery, such as a diagnostic tonsillectomy, this is considered acceptable and further robotic surgery is not necessary.\n* Have undergone or will undergo neck dissection.\n* Have at least one of the following after surgery:\n\n  * Pathologic stage T3\n  * 2 or more positive lymph nodes\n  * At least one lymph node \\>3cm\n  * Contralateral lymph node involvement\n  * Lymphovascular invasion\n  * Perineural invasion\n  * Extranodal extension\n  * Close\u002Fpositive margins: Close margins are considered ≤3mm from the peripheral margins and ≤1mm from the deep margin on the en bloc specimen, unless the area of close margin is re-resected and without carcinoma.\n* Patients consented preoperatively are required to have detectable cTTMV-HPV DNA based on pre-operative NavDx testing. For patients consented post-operatively, NavDx testing should be performed on the tumor tissue to ensure detectable HPV DNA and for HPV subtyping.\n* Age ≥ 18 years old\n* ECOG performance status 0 or 2 within 56 days of start of chemoradiation.\n* Women of childbearing potential require a negative serum or urine pregnancy test within 28 days prior to start of chemoradiation.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n* Adequate hematologic and renal function within 56 days of start of chemoradiation, defined as:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Platelets ≥ 100, 000 cells\u002Fmm3\n  * ANC ≥ 1.5 X 109\u002FL\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * Aspartate aminotransferase\u002Falanine aminotransferase ≤ 3.0 x upper limit of normal (ULN)\n  * Serum creatinine ≤1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 mL\u002Fmin estimated using the following Cockcroft-Gault equation\n\nExclusion Criteria:\n\n* AJCC 8th edition pT4 or cN3 disease.\n* Radiologic or clinical evidence of distant metastasis.\n* Recurrent disease.\n* Inability to achieve gross total resection at time of surgery.\n* Greater than 56 days (8 weeks) after surgical resection of the primary site.\n* Prior radiation to the head and neck \\> 30 Gy.\n* Prior active invasive (not in situ) malignancy within the prior 2 years, excluding cutaneous basal cell or squamous cell carcinoma, low or intermediate risk prostate cancer, papillary thyroid cancer, stage T1aN0 kidney cancer, low-grade T1-2N0 salivary cancer, AJCC 8th edition stage I-II breast cancer, well-differentiated neuroendocrine tumors (e.g., carcinoid tumors), low grade non-Hodgkin lymphoma, or Stage 0, I, and III cutaneous melanomas. Patients with synchronous or multifocal oropharyngeal cancers are not excluded, as long as at least one of these tumors meet inclusion criteria for the trial.\n* Severe, active co-morbidity, defined as follows:\n\n  * 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 at the time of enrollment\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For known coagulation defects\n* Moderate to severe hearing loss.\n* Active connective tissue disease (e.g. systemic lupus erythematous, scleroderma) requiring immunosuppression.\n* Pregnant or breast-feeding women.\n* Prior allergic reaction to cisplatin.\n* Live vaccines within 30 days prior to the first dose of chemoradiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral vaccine). Season influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed.",{"count":166,"type":22},50,[168],"PHASE2","This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.",[57,171],"Carcinoma",[173,174,175],"Transoral Robotic Surgery (TORS)","pT0 tumors (unknown primary)","p16","2026-05-05",{"date":178,"type":91},"2026-05-08",{"date":180,"type":91},"2025-05-12",{"date":182,"type":22},"2032-06",{"name":184,"class":98},"Zachary Zumsteg",4,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":111,"phases":195,"briefSummary":196,"conditions":197,"keywords":201,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100477019","phase-2-a-study-of-reduced-radiation-therapy-and-standard-of-care-chemotherapy-in-people-with-hpv-positive-throat-cancer-100477019","NCT05491512","A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer","Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from biopsy, surgical resection or excisional biopsy regardless of margin status.\n\n  1. Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI\n  2. Patient must have excisional biopsy or core biopsy done in order to be on protocol\n* Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations.\n* Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET\u002FCT.\n* CT or MRI of the neck with and without contrast Note: A CT scan of neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as planning tools.\n* ECOG Performance Status of 0-2 or KPS ≥ 50\n* Age ≥ 18 Patients over 70yrs will be able to enroll in Cohort B only).\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  1. White Blood Count (WBC) ≥ 2 K\u002FmcL\n  2. Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  3. Platelets ≥ 100,000 cells\u002Fmm3\n  4. Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  1. Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n\nNote: Patients who cannot tolerate cisplatin or carboplatin\u002F5FU based on clinical judgment will receive carboplatin and paclitaxel Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).\n\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  1. Bilirubin \\\u003C 2 mg\u002Fdl\n  2. AST or ALT \\\u003C 3 x the upper limit of normal\n\nNote: Exceptions can be made with PI and\u002For Co-Pi approval for patients to enroll on trial with a higher Bilirubin level such as Gilbert's Syndrome.\n\nNote: Patients who cannot tolerate cisplatin or carboplatin\u002F5FU based on clinical judgment will receive carboplatin and paclitaxel. Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).\n\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n* The subject must provide study-specific informed consent prior to study entry\n* Subject able to undergo MRI scans except for major medical contraindications like presence of a pacemaker or approved by the PI or the CO-PI that the subject does not need to undergo MRI scans\n\nExclusion Criteria:\n\n* Subjects with prior head and neck radiation therapy\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  a. Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI\u002FCo-PI the patient can proceed with protocol activities.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable\n* Severe, active co-morbidity defined as follows: (exceptions can be made if approved by the PI and\u002For co-PI)\n\n  1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  2. Transmural myocardial infarction within the last 6 months\n  3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n  4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  5. Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defects",{"count":194,"type":22},121,[168],"The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).",[198,199,200,57,142],"HPV","Throat Cancer","Oropharyngeal Carcinoma",[202,198,199,142,200,57,203,204,205],"HPV-Positive Throat Cancer","Radiation Therapy","22-215","Memorial Sloan Kettering Cancer Center","2026-04-22",{"date":208,"type":91},"2026-04-23",{"date":210,"type":91},"2022-08-04",{"date":212,"type":22},"2027-08-04",{"name":205,"class":98},7,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":111,"phases":225,"briefSummary":226,"conditions":227,"keywords":233,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":157},"100609025","phase-2-neoadjuvant-chemotherapy-and-programmed-cell-death-protein-1pd-1-inhibition-for-head-and-neck-cancer-treatment-de-escalation-neoscorch-hn-100609025","NCT07209189","Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","Neoadjuvant Chemotherapy and PD-1 Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","(NeoScorch HN)","Inclusion:\n\n* Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined.\n* HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted surgery.\n* HPV-associated HNSCC with radiographic extranodal extension (cT1-cT3 tonsil or lateralized base of tongue, N0-N1, up to 4 nodes with rENE).\n* Sinonasal\u002Fskull base tumors, including: sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).\n* HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.\n* At least 8 unstained 5-µm slides must be available. If unavailable, a new biopsy is required unless waived by the PI.\n* Appropriate candidates for curative-intent therapy.\n* American Joint Committee on Cancer (AJCC) 7th edition: Stage III-IV, excluding N2c or bulky N2b\u002Fc (N3 equivalent) and bulky T4 (≥30cc).\n* AJCC 8th edition: Stage I with N1, Stage II, or Stage III, excluding N2 disease, bulky nodal disease (N3 equivalent), or bulky T4 (≥30cc).\n* Surgical arm: Candidates must be operable based on upfront imaging\u002Fexam. Patients with Grade 1 rENE may proceed to surgery; Grade 2\u002F3 rENE are excluded.\n* Measurable disease per RECIST 1.1.\n* No prior systemic therapy, radiotherapy, or investigational agents for the current cancer.\n* No complete surgical resection within 8 weeks of enrollment (biopsy or excision with residual disease acceptable).\n* Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky ≥70%.\n* Platelets ≥100,000\u002FµL.\n* Absolute Neutrophil Count (ANC) ≥1,500\u002FµL.\n* Hemoglobin ≥9 g\u002FdL (without recent transfusion\u002FEPO).\n* Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) \\\u003C2.5 × ULN.\n* Albumin ≥2.5 mg\u002FdL.\n* Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total \\>1.5 × ULN (Upper Limit of Normal).\n* Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault or measured GFR).\n* International Normalized Ratio (INR)\u002F Prothrombin Time (PT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Must sign and understand a study-specific informed consent form.\n* Women of childbearing potential (WOCBP): Negative pregnancy test within 72 hours prior to first dose.\n* WOCBP must not be breastfeeding and must agree to use highly effective contraception during therapy and for 120 days after last dose.\n* Men: Must use adequate contraception during treatment and for 120 days after last dose; condom use required in addition to highly effective methods.\n* Azoospermic men and WOCBP not heterosexually active are exempt from contraception but must still undergo pregnancy testing.\n* Counseling on pregnancy prevention is mandatory.\n* Highly effective methods (\\\u003C1% failure rate with consistent use) must be used\n\nExclusion:\n\n* WOCBP with a positive urine pregnancy test within 72 hours before treatment allocation; if positive or inconclusive, a confirmatory serum pregnancy test is required.\n* Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.\n* Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., Cytotoxic T-lymphocyte antigen 4 (CTLA-4), OX40 (Tumor Necrosis Factor Receptor Superfamily Member 4), CD137).\n* Prior systemic anti-cancer therapy or radiotherapy for the current cancer. Surgery is allowed if adequately recovered from complications.\n* Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-Central Nervous System (CNS), non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.\n* Live or live-attenuated vaccines within 30 days of first study dose (including live Corona Virus Disease (COVID-19) vaccines). Inactivated, Messenger ribonucleic acid (mRNA), and peptide vaccines are allowed.\n* Concurrent treatment with other investigational agents.\n* Participation in another investigational drug or device study within 4 weeks before first study dose, unless in follow-up phase only.\n* Diagnosis of immunodeficiency, or receiving chronic systemic steroids at doses \\>10 mg prednisone equivalent daily, or other immunosuppressive therapy within 7 days before study drug.\n* Active autoimmune disease requiring systemic treatment in the past 2 years. Physiologic replacement therapy (thyroxine, insulin, low-dose steroids for adrenal or pituitary insufficiency) is allowed.\n* History of severe hypersensitivity (≥Grade 3) to Toripalimab, its excipients, or other anti-PD-1 agents.\n* Additional active malignancy requiring treatment within 2 years, except basal\u002Fsquamous cell skin cancers, in situ cancers, low-grade tumors unlikely to affect survival within 3 years, or cancers treated with curative therapy.\n* Active CNS metastases or carcinomatous meningitis. Intracranial extension of the primary tumor is allowed. Patients with previously treated brain metastases may enroll if radiologically stable ≥4 weeks, clinically stable, and off steroids ≥14 days before study drug.\n* History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis\u002FInterstitial Lung Disease (ILD).\n* Active infection requiring systemic therapy.\n* Known HIV infection.\n* Known active Hepatitis B (HBsAg positive) or active Hepatitis C (HCV RNA positive). Patients with cleared or eradicated Hepatitis B (HBV) or HCV are eligible.\n* Any condition, therapy, or abnormality that could confound study results, interfere with participation, or be judged by the investigator as not in the participant's best interest.\n* Known psychiatric illness or substance abuse that could interfere with study compliance. Stable chronic managed disorders are acceptable.\n* History of allogeneic tissue or solid organ transplant.\n* Significant cardiovascular disease, including congestive heart failure (NYHA Class III or IV), unstable angina, serious uncontrolled arrhythmia, myocardial infarction within 6 months, or prior myocarditis.",{"count":224,"type":22},75,[168],"The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.",[228,143,55,57,53,229,230,231,232],"Head and Neck Cancer","Sinonasal Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","Skull Base Tumors","HPV 16 Positive Oropharyngeal Tumors (OPC)",[234,235,236,237,238,239],"head and neck cancer","oral cancer","oropharyngeal cancer","laryngeal cancer","HPV associated","squamous cell carcinoma","2026-04-21",{"date":208,"type":91},{"date":243,"type":91},"2026-02-18",{"date":245,"type":22},"2030-12-01",{"name":247,"class":98},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":111,"phases":257,"briefSummary":258,"conditions":259,"keywords":267,"overallStatus":274,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100625084","phase-2-a-single-arm-phase-ii-trial-in-p16-positive-oropharynx-cancer-of-selective-dose-de-escalation-of-nodal-volumes-at-minimal-risk-and-primary-site-disease-saved-100625084","NCT07418034","A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)","SAVED","4.1 Step 1 Registration 4.1.1 Step 1 Inclusion\n\n(Y) 1. Is there pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n\n(Y) 2. Is the patient ≥ 18 years of age?\n\n(Y) 3. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\n(Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):\n\nTORS candidate patients must be:\n\n• cT0-4 and N0, N1, N3\n\nNon-TORS candidate patients must be either:\n\n* cT1-4 N0, N1, N3\n* cT1-3 N2 with \\\u003C 10 pack years\n\n4.1.2 Step 1 Exclusion\n\n(N) 1. Patient who are clinical N2 and have ≥10 pack years smoking history\n\n(N) 2. Patients who are clinical T4N2\n\n(N) 3. Patients with distant metastasis (M1)\n\n4.2 Step 2 Registration 4.2.1 Step 2 inclusion\n\n(Y) 1. Does the patient have pathologically (histologically or cytologically) proven P16+ status?\n\n(Y) 2. Does the patient have appropriate imaging (PET\u002FCT preferred, CT neck with IV contrast and CT chest without contrast as recommended alternative to PET\u002FCT) completed within 90 days of enrollment?\n\n(Y) 3. Does the patient have clinical or pathological M0 staging? (Y) 4. Patients who have undergone TORS must have pathological stage pT1-4 N0, N1 or N3. TORS patients found to be clinical N2 post TORS or have contralteral neck dissection and positive nodes will be excluded.\n\n(Y) 5. Is the patient a candidate for bilateral radiation based on evaluation by ENT, Rad Onc, or Med Onc and review at multi-disciplinary tumor board?\n\n(Y) 6. Non-TORS patients who are cT1-3 N0, N1, N2 and have \\\u003C10 PY must have completed a ctDNA evaluation prior to Step 2 enrollment.\n\n(Y) 7. Non-TORS patients who are cT1-3 N2 must have a positive ctDNA result prior to Step 2 enrollment.\n\n(Y) 8. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n\n(Y) 9. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n\n(Y) 10. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n\n4.2.2 Step 2 Exclusion\n\n(N) 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n\n(N) 2. Does the patient have distant metastasis?\n\n(N) 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low\u002Fintermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n\n(N) 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n\n(N) 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n\n(N) 6. Did the patient have prior cancer-related surgeries of curative intent of the head and neck excluding superficial removal of cutaneous skin malignancies?\n\n(N) 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n\n(N) 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n\n(N) 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?",{"count":256,"type":22},132,[168],"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care.\n\nStudies have reported that lowering radiation doses for some patients can reduce side effects while still effectively controlling the cancer.\n\nPatients with this type of head and neck cancer typically receive either surgery or radiation as their first treatment.\n\nFor patients who receive surgery first, radiation to the surgical area and nearby neck lymph nodes is often recommended afterward. In these patients, the study will test whether lowering the radiation dose to low-risk lymph nodes on the side of the neck opposite the tumor can reduce side effects while still effectively controlling the cancer (Method A).\n\nFor patients who receive radiation as their first treatment, the study will test one or both of two radiation approaches aimed at reducing both short-term and long-term side effects. These approaches include reduced lymph node radiation (Method A, described above) and a tumor dose reduction approach (Method B), which lowers the radiation dose delivered directly to the tumor.\n\nInformation such as tumor size, the number of cancerous or suspicious lymph nodes, and risk factors like smoking history will be used to determine which patients may be eligible for reduced lymph node radiation (Method A), reduced tumor radiation (Method B), or both. Patients who may qualify for tumor dose reduction (Method B), either alone or combined with Method A, will need an additional blood test called a circulating tumor DNA (ctDNA) test to determine eligibility.\n\nThe ctDNA test measures small amounts of tumor-related DNA in the blood, which are often elevated at the time of diagnosis. Studies have shown that cancer is more likely to return when ctDNA levels remain positive after treatment. This study will evaluate whether ctDNA levels measured before and during treatment can help identify patients who can safely receive lower radiation doses to the tumor (Method B).\n\nOverall, this study aims to safely evaluate two radiation de-escalation approaches in order to lessen short- and long-term side effects while maintaining excellent cancer control.",[228,260,261,200,262,263,146,264,141,57,265,266,230,232],"Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma (OPSCC)","Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma (SCC)","Oropharyngeal Squamous Cell Cancer","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[173,228,268,269,270,271,203,272,273],"Oropharynx Cancer","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","ctDNA","P16 positive","NOT_YET_RECRUITING","2026-02-10",{"date":243,"type":91},{"date":278,"type":22},"2026-05",{"date":280,"type":22},"2033-05",{"name":282,"class":98},"University of Maryland, Baltimore",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":293,"conditions":294,"keywords":298,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":157},"100498769","role-of-liquid-biopsies-in-hpv-associated-cancer-treatment-monitoring-100498769","NCT05774561","Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring","Liquid Biopsies - a Possible Tool for Treatment Monitoring and Early Recurrence Detection in HPV-associated Diseases","Inclusion Criteria:\n\nWomen diagnosed with CC\u002FHSIL. Men and women diagnosed with OPC. Patients must agree with study enrollment and must sign study informed consent.\n\nExclusion Criteria:\n\nNo exclusion criteria are set.","99 Years",{"count":292,"type":22},480,"This trial will evaluate the possible benefits and the performance of liquid biopsies in HPV-associated cancer treatment monitoring. This study aims to find a combination of an adequately sensitive and specific sampling method and biomarkers for early risk stratification of disease recurrence.",[295,296,57,297],"Cervical Cancer","Cervical Dysplasia","Human Papillomavirus Infection",[299,198,300,301,302,236],"human papillomavirus","liquid biopsies","cervicovaginal swab","cervical cancer",{"date":304,"type":91},"2026-02-12",{"date":306,"type":91},"2022-06-01",{"date":308,"type":22},"2026-12-01",{"name":310,"class":98},"The Institute of Molecular and Translational Medicine, Czech Republic",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":16,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100539579","biomarker-approach-to-screening-for-the-early-detection-of-hpv-related-oropharyngeal-cancer-bash-opc-100539579","NCT06305676","Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)","BASH OPC","Inclusion Criteria:\n\nCases:\n\n* Aged at least 18 years\n* Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)\n* Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks\n* Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker\u002Fbiobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center\n* Aged at least 35 years\n* Have no previous diagnosis of HNC or HPV-related cancer\n* Fully understands study procedures\n* Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker\u002Fbiobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center\n\nExclusion Criteria:\n\n* Not meeting all of the above inclusion criteria for either the case or control group",{"count":319,"type":22},400,"Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race\u002Fethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).",[57,322],"HPV-Related Carcinoma",[57,324,325],"Early Detection","Screening","2026-02-05",{"date":328,"type":91},"2026-02-09",{"date":330,"type":91},"2024-01-22",{"date":332,"type":22},"2029-01",{"name":334,"class":98},"H. Lee Moffitt Cancer Center and Research Institute",2,{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":111,"phases":346,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":274,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":157},"100623892","phase-3-surgery-with-or-without-neoadjuvant-treatment-of-sbrt-plus-chemoimmunotherapy-in-resectable-locally-advanced-oral-and-hpv-unrelated-oropharyngeal-squamous-cell-carcinoma-100623892","NCT07402538","Surgery With or Without Neoadjuvant Treatment of SBRT Plus Chemoimmunotherapy in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma","SBRT Followed by Neoadjuvant Chemoimmunotherapy Before Surgery in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma: a Randomized Controlled Phase III Trial","The inclusion criteria for this study are as follows:\n\n* Histologically and\u002For cytologically confirmed treatment-naïve oral squamous cell carcinoma or HPV-negative oropharyngeal squamous cell carcinoma.\n* Clinical stage III -Ⅳa (8th edition of AJCC).\n* Age: 18 to 75 years old.\n* According to the Eastern Cooperative Oncology Group (ECOG) criteria (with a performance status score of 0 or 1).\n* Good organ function.\n* Expected survival time: ≥ 3 months.\n* The patient has signed the informed consent form and is willing and able to comply with the study's scheduled visits, treatment plans, laboratory tests, and other research procedures.\n* Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrolment and must agree to use highly effective contraceptive measures during the study period and for at least 60 days after the last dose (including chemotherapeutic drugs and Tislelizumab).\n* If the female partner of a male subject is still of childbearing potential, the male subject must agree to use highly effective contraceptive measures during the study period and for at least 60 days after the last dose.\n\nExclusion Criteria:\n\n* Patients with concurrent other malignant tumors\n* Patients with known or suspected autoimmune diseases, including dementia and epilepsy.\n* Patients with severe mental disorders at the same time\n* Patients with necrotic lesions who are assessed by the investigator as having a risk of massive hemorrhage\n* Patients with severe heart disease or pulmonary dysfunction, and those with cardiac or pulmonary function grade ≤ 3 (grade 3 inclusive)\n* Patients with laboratory test results that do not meet the relevant criteria within 7 days prior to enrollment\n* Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment\n* Patients with comorbidities requiring long-term treatment with immunosuppressive drugs, or requiring systemic or local administration of corticosteroids at immunosuppressive doses.\n* Patients with active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.\n* A history of prior use of anti-Tislelizumab, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or checkpoint pathways).\n* Subjects with any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or those whose childhood asthma has been completely relieved and who do not require any intervention in adulthood are eligible for enrollment; those with asthma requiring medical intervention with bronchodilators are not eligible for enrollment.\n* HIV-positive subjects\n* Positive for HBsAg with concurrent positive HBV DNA copy number (quantitative test ≥ 1000 cps\u002Fml); positive for chronic hepatitis C on blood screening (HCV antibody positive)\n* Received any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment\n* Pregnant women with positive pregnancy test results among females of childbearing potential and lactating women.","75 Years",{"count":345,"type":22},184,[113],"The objective of this study is to evaluate the efficacy of neoadjuvant stereotactic body radiation therapy (SBRT) in combination with chemotherapy and immunotherapy, prior to radical surgery, in enhancing the 2-year event-free survival rate and overall survival rate in patients diagnosed with locally advanced oral or HPV-unrelated oropharyngeal cancer.",[349,57],"Oral Cancer",[351,352,353],"SBRT","neoadjuvant therapy","locally advanced oral\u002Foropharyngeal cancer","2026-02-04",{"date":356,"type":91},"2026-02-11",{"date":358,"type":22},"2026-02-24",{"date":360,"type":22},"2030-12-31",{"name":362,"class":98},"Sun Yat-sen University",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":111,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":157},"100615285","phase-2-toripalimab-in-combination-with-standard-treatment-for-human-papillomavirus-hpv-positive-throat-cancer-100615285","NCT07290621","Toripalimab in Combination With Standard Treatment for Human Papillomavirus (HPV) Positive Throat Cancer","Phase II Trial of Neoadjuvant Toripalimab in Combination With Chemotherapy Followed by Transoral Robotic Surgery or Risk\u002FResponse Stratified Chemoradiotherapy for Locoregional HPV16+ Oropharyngeal Cancer: TARGET HPV Cohort 2","Inclusion Criteria:\n\n* Subjects must have pathologically confirmed HPV16-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.\n* HPV16 subtype demonstrated based on the following guidelines:\n\n  * p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al72).\n  * HPV PCR must demonstrate HPV16 subtype.\n  * Following p16 IHC positivity, HPV16 is to be demonstrated using HPV PCR which is anticipated to result prior to cycle 1 day 15.\n* Patients must be at least 18 years of age.\n* Subjects with AJCC (8th edition, 2018) N1 (if solitary lymph node must be \\>=3cm), N2-N3 nodal disease or T3-T4 primary tumor (with any N).\n* Measurable disease (either primary site and\u002For nodal disease) by RECIST 1.1 criteria.\n* No previous radiation or chemotherapy for a head and neck cancer.\n* No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy\u002Fexcision of the tumor with residual measurable disease is acceptable.) No surgical procedures or biopsies will occur after baseline scans are performed and measurable lesions are identified.\n* ECOG performance status 0-1\n* Normal Organ Function per protocol criteria\n* Patients must be considered to be a candidate to receive cisplatin by the treating physician.\n* Patients must sign a study-specific informed consent form prior to study entry. Patients should have the ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug.\n* Women must not be breastfeeding.\n* Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.\n* Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).\n\nExclusion Criteria:\n\n* Unequivocal demonstration of distant metastatic disease (M1 disease).\n* Non-HPV16 subtype.\n* Unidentifiable primary site.\n* Intercurrent medical illnesses that impairs the patient's tolerance to therapy or limits survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance. Patients with clinically stable and\u002For chronically managed medical illnesses that are not symptomatic and\u002For are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).\n* Subject with low risk N1 disease (defined as single lymph node \\\u003C3cm)\n* Active, known, or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low-dose prednisone (\\\u003C= 10mg or equivalent). The following are exceptions to these criteria:\n\n  * Patients with vitiligo or alopecia.\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n  * Any chronic skin condition that does not require systemic treatment.\n* Treatment with immunosuppressive or replacement medication:\n* Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses \\> 10 mg\u002Fday prednisone or equivalent), within 14 days of the first administration of study treatment. Note: inhaled or topical steroids and adrenal replacement in doses equivalent to \\> 10 mg\u002Fday prednisone are permitted in the absence of active autoimmune disease.\n* Any chronic immunosuppressive medication within 6 months prior to the first administration of study treatment (unless agreed otherwise between the Sponsor and the Investigator on a case-by-case basis).\n* Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Patients who have had a prior anaphylactic or other severe reaction to human immunoglobulin or antibody formulation administration.\n* Herbal remedies with immune-stimulating properties or known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise with the primary investigator.\n* Prior surgical therapy other than incisional\u002Fexcisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.\n* Patients receiving other investigational agents.\n* Prior systemic anti-cancer treatment within the last 8 weeks.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment.\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has known active Hepatitis B or hepatitis C. If eradicated, patient is eligible.\n* Has received a live vaccine within 28 days of planned start of study therapy.",{"count":136,"type":22},[168],"This is a single-center phase 2 study of to test how well the combination of toripalimab with chemotherapy followed by TORS or risk and response stratified de-escalated (chemo)radiotherapy works in patients with in HPV16+ locoregionally advanced oropharyngeal cancer (OPC).",[57],"2026-02-03",{"date":376,"type":91},"2026-02-06",{"date":378,"type":22},"2026-02",{"date":380,"type":22},"2033-02",{"name":382,"class":98},"University of Chicago",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":111,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":157},"100507952","phase-2-a-phase-ii-study-for-p16-oropharyngeal-cancer-personalized-de-escalation-treatment-at-university-of-michigan-customize-100507952","NCT05894083","A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)","Inclusion Criteria:\n\n* Patients must have FDG-avid (maximum SUV ≥ 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) or unknown primary that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization\n* Clinical stage: Stage I-II AJCC 8th edition staging\n* Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\n\n  * History\u002Fphysical examination, including documentation of weight within 4 weeks prior to registration;\n  * For Cohort B, FDG-PET\u002FCT scan for staging within 6 weeks prior to registration. For Cohort A, acceptable imaging for staging can include diagnostic CT neck\u002Fchest or PET-CT within 6 weeks prior to registration\n  * Zubrod Performance Status 0-1 within 4 weeks prior to registration;\n  * Age ≥ 18;\n  * Able to tolerate PET\u002FCT imaging required to be performed\n* For Cohort A, tumors must be potentially surgically resectable via a transoral approach, at the discretion of the treating surgeon. Additionally, they must have 0-2 clinically positive LNs on diagnostic CT or PET-CT according clinical consensus of the treatment team\n* For both cohorts, CBC required within 4 weeks prior to registration. For Cohort B, CBC\u002Fdifferential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3;\n  * Platelets ≥ 100,000 cells\u002Fmm3;\n  * Hemoglobin ≥ 8.0 g\u002FdL\n* Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml\u002Fmin within 4 weeks prior to registration.\n* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.\n* The patient must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* cT4, cN3, or cM1 disease (also explained as AJCC 8th edition clinical staging,)\n* Patients with radiographic ECE or matted lymph nodes, defined as three nodes abutting one another with loss of intervening fat plane that is a replaced with radiologic evidence of extracapsular spread.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \\>3 years prior to study;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Prior allergic reaction or hypersensitivity reactions to paclitaxel, carboplatin or other platinum containing products. This also includes patients with a history of severe hypersensitivity reaction to products containing Cremophor EL.\n* Severe, active co-morbidity, defined as follows:\n* Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n\n  * Transmural myocardial infarction within the last 3 months;\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;\n  * Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;\n  * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.\n  * Severe bone marrow depression or significant bleeding\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.\n* For Cohort B, poorly controlled diabetes (defined as fasting glucose level \\> 200 mg\u002FdL) despite 2 attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians.\n* Active enrollment on another clinical trial involving active treatment for the study cancer.",{"count":390,"type":22},150,[168],"Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+\u002F-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).",[57,394],"Squamous Cell Carcinoma of the Oropharynx","2026-01-30",{"date":397,"type":91},"2026-02-02",{"date":399,"type":91},"2023-04-27",{"date":401,"type":22},"2030-12",{"name":403,"class":98},"University of Michigan Rogel Cancer Center",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":413,"conditions":414,"keywords":418,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":157},"100505546","liposomal-bupivacaine-and-transoral-robotic-surgery-100505546","NCT05862792","Liposomal Bupivacaine and Transoral Robotic Surgery","Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery","Inclusion Criteria:\n\n* Adult patients, greater than or equal to 18 years of age; Patients of all genders; Patients undergoing transoral robotic surgery; Patient who are able and willing to give consent\n\nExclusion Criteria:\n\n* Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency",{"count":412,"type":22},80,"This study is for patients with oropharyngeal squamous cell carcinoma. We want to learn more about how we can optimize pain control in patients who undergo transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma. Our goal is to determine if a local anesthetic called EXPAREL® (Liposomal Bupivacaine) impacts postsurgical pain and swallow function in patients with oropharyngeal squamous cell carcinoma undergoing TORS. EXPAREL® is an FDA-approved anesthetic drug that provides long-lasting and precise pain relief when injected into the surgical wound. Our study team wants to determine if injecting EXPAREL® into the surgical wound will provide better pain relief and swallow function when compared to patients who do not undergo postoperative EXPAREL® injection. Both options for postoperative pain control are considered standard of care for patients undergoing TORS.",[57,415,416,417],"Dysphagia, Oropharyngeal","Post Operative Pain","Transoral Robotic Surgery",[236,239,419,420],"postoperative pain","transoral robotic surgery","2025-09-05",{"date":423,"type":91},"2025-09-09",{"date":425,"type":91},"2023-06-01",{"date":427,"type":22},"2026-01-15",{"name":429,"class":98},"Geisinger Clinic",{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":111,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":157},"100550410","phase-1-pirates-image-guided-hyper-fractioned-dose-escalation-with-proton-therapy-for-head-and-neck-cancer-100550410","NCT06446713","PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer","Proton Image-guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients","PIRATES","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx.\n* Routine staging procedures, including CT of the head and neck region and chest, head and neck FDG-PET\u002FCT and MRI (treatment planning allowed), and endoscopic evaluation when indicated.\n* Negative for p16\n* Locally advanced disease, specifically meeting all following criteria:\n\n  * Stage III-IV\n  * T-stage 2-4\n  * All N-stages (N0-3)\n  * M0\n* Eligible for primary concurrent chemoradiation using conventionally fractionated radiotherapy 70 Gy combined with weekly cisplatin\n* Eastern Cooperative Oncology Group (ECOG) performance score ≥2\n* Age ≥18 years\n* Written informed consent\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study; patients that:\n\n* underwent definitive resection of their primary tumor or nodal disease, except for incisional or excisional biopsies.\n\nreceived radiation therapy in the head and neck area in the past\n\n* have no detectable tumor anymore at both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost.\n* are unable or unwilling to give written, informed consent\n* have contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist.\n* are unable to tolerate intravenous contrast for both CT and MRI, having an estimated GFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2 or any contraindications to gadolinium-based contrast agents.\n* have any evidence of iron overload on pre-imaging laboratory studies.\n* have other serious illnesses or medical conditions present at entry in the study, including (but not limited to): immunodeficiency virus (HIV) infection or other conditions of persistent immunodeficiency, neurologic or psychiatric disorders, active disseminated intravascular coagulation, unstable cardiac disease despite treatment or uncontrolled diabetes mellitus.\n* Women who are pregnant or breast feeding",{"count":439,"type":22},17,[138],"In this study the safety \\& feasibility of image-guided mid-treatment hyper-fractioned dose-escalation with proton therapy will be assessed for the treatment of locally advanced HPV-negative squamous cell oropharyngeal cancer",[228,57],[444,445,446,447,448],"Proton therapy","Hyperfractionation","Dose-escalation","Image guidance therapy","Adaptive radiotherapy","2025-03-31",{"date":451,"type":91},"2025-04-03",{"date":453,"type":22},"2025-05-01",{"date":455,"type":22},"2029-01-01",{"name":457,"class":98},"University Medical Center Groningen",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":111,"phases":467,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":335},"100400744","lymphatic-mapping-of-oropharyngeal-cancer-100400744","NCT04498221","Lymphatic Mapping Of Oropharyngeal Cancer","Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer","LOOC","Inclusion Criteria:\n\n* Adults aged 18 or over\n* New diagnosis of OPC - all anatomical subsites and HPV status accepted\n* Unilateral metastatic nodes equating to AJCC TNM8 clinical staging N1-N2b for P16 negative and N1 for P16 positive patients.\n\nExclusion Criteria:\n\n* Suspicious bilateral nodes on imaging\n* Previous radiotherapy or surgery to the neck\n* Second primary oropharyngeal tumours\n* Distant metastasis (e.g. lung, bone)\n* Pregnancy and lactation\n* Inability to give informed consent\n* Allergy to lymphatic tracers",{"count":390,"type":22},[468],"NA","A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current gold standard in identifying sentinel nodes in patients with oropharyngeal cancer.",[57],"2024-09-11",{"date":473,"type":91},"2024-09-19",{"date":475,"type":91},"2022-07-07",{"date":477,"type":22},"2027-01",{"name":479,"class":98},"University College, London",{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":111,"phases":488,"briefSummary":489,"conditions":490,"keywords":497,"overallStatus":274,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":510,"leadSponsor":512,"locationsCount":4},"100484019","phase-1-autologous-t-cells-targeting-hpv16-hpv18--survivin-in-patients-with-rr-hpv-related-oropharyngeal-cancers-100484019","NCT05582590","Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R\u002FR HPV-related Oropharyngeal Cancers","A Phase 1 Open-Label Dose-Escalation Study of the Safety of Adoptively Transferred Autologous CD8+ T Lymphocytes Targeting HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 and Survivin in Patients With Relapsed or Refractory HPV-related Oropharyngeal Cancers","Inclusion Criteria:\n\n1. The patient will be typed for HLA-A\\*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor.\n2. Patients with cytologically or histologically confirmed locally advanced or metastatic HPV related oropharyngeal cancers with confirmed detection of HPV-16 and\u002For HPV-18.\n3. Patients with HPV-related oropharyngeal cancers who have received at least 1 prior line of standard-of-care (SOC) treatment (for example, per the current NCCN Guidelines for Patients with Oropharyngeal Cancer) consisting of systemic immunotherapy and\u002For chemotherapeutic treatment.\n\n   1. The last dose of cytotoxic chemotherapy and\u002For steroids must be administered at least 28 days prior to the leukapheresis procedure.\n   2. Any adverse event(s) that the patient may have experienced from prior therapy must have resolved to ≤ Grade 1 according to NCI CTCAE version 5.0.\n4. Measurable disease per RECIST v1.1 criteria (at least 1 lesion that can be measured accurately in at least 1 dimension with the longest diameter ≥ 10 mm \\[MRI or CT scan sliced thickness ≤ 5 mm\\]).\n5. Pulse oximetry ≥ 92% on room air.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Life expectancy of at least 3 months.\n8. Be willing to comply with the study schedule and all other protocol requirements.\n9. Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have 2 negative pregnancy tests prior to treatment. All sexually active WOCBP and all sexually active male patients must agree to use highly effective methods of birth control throughout the study.\n10. Ability of the patient to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment. Patients taking adjuvant hormonal therapy for definitively treated cancers (e.g., breast cancer, prostate cancer) are eligible.\n2. Major surgery within 28 days prior to the first study drug administration (minimally invasive procedures, such as diagnostic biopsies, are permitted).\n3. Known central nervous system involvement.\n4. Treatment with an allogeneic hematopoietic stem cell transplantation.\n5. Treatment with any investigational agent(s) at the time of informed consent.\n6. Left ventricular ejection fraction (LVEF) \\\u003C 45%, congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.\n7. The following hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support):\n\n   1. Hemoglobin \\\u003C 9.0 g\u002FdL.\n   2. Platelet count \\\u003C 100,000\u002FμL.\n   3. Absolute neutrophil count (ANC) \\\u003C 1000\u002F μL.\n8. The following chemistry laboratory results at Screening:\n\n   1. Serum creatinine ≥ 1.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) ≤ 50 mL\u002Fmin\u002F1.73 m\\^2.\n   2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3x the upper limit of normal (ULN) or serum total bilirubin \\> 2 mg\u002FdL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome).\n9. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\> 1.5x ULN within 1 week prior to the start of lymphodepletion chemotherapy, unless on a stable dose of an anticoagulant.\n10. Are pregnant or breastfeeding.\n11. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment.\n\n    1. Inactivated annual influenza vaccination is allowed.\n    2. Vaccines such as COVID-19 vaccine, e.g., SARS-CoV-2 vaccine \\> 7 days before administration is acceptable. For vaccines requiring more than 1 dose, the full regimen should be completed prior to Cycle 1 Day 1.\n12. Active bacterial, viral, or fungal infection within 72 hours of the start of lymphodepletion chemotherapy; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection.\n13. Have human immunodeficiency virus (HIV) active infection as indicated by positive HIV polymerase chain reaction (PCR) test, human T-cell leukemia virus type 1 infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being hepatitis B surface antigen \\[HbsAg\\] positive, or anti-HBe-antibody positive), or are positive for HBV DNA. HCV ribonucleic acid (RNA) must be undetectable by laboratory test.\n14. Any condition including the presence of laboratory abnormalities, that places the patient at an unacceptable risk if the patient was to participate in the study.\n15. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n    Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.\n16. Patients who experienced the following immune checkpoint inhibitor-related AEs even if the AE resolved to ≤ Grade 1 or baseline:\n\n    1. ≥ Grade 3 ocular AE\n    2. Changes in liver function tests that met the criteria for Hy's Law (\\> 3× ULN of either ALT\u002FAST with concurrent \\> 2× ULN of total bilirubin (total and direct) and without alternate etiology)\n    3. ≥ Grade 3 neurologic toxicity\n    4. ≥ Grade 3 colitis\n    5. ≥ Grade 3 renal toxicity",{"count":126,"type":22},[138],"This is a multicenter, open-label, Phase I, first-in-human trial to characterize the safety and clinical activity of an antigen-specific CD8+ T-cell product in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers. Patients must have received at least one prior standard treatment regimen consisting of systemic immunotherapy and\u002For chemotherapy. The investigative agent is an autologous adoptive T-cell product derived from the patient's endogenous cytolytic T cells that are directed toward HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 antigens, and a tumor-associated antigen (Survivin) by ex vivo exposure to an artificial antigen presenting cell to which HLA-A2 antigen-peptides have been fit within the pocket of an MHC class 1 molecule. Patients must express HLA-A\\*0201.",[57,142,228,261,146,491,492,493,494,495,496],"Oropharyngeal Cancer, Metastatic","Head and Neck Cancer Metastatic","HPV-Related Squamous Cell Carcinoma","HPV-Related Mucosal Head and Neck Squamous Cell Carcinoma","Relapsed Oropharyngeal SCC","Refractory Oropharyngeal Squamous Cell Carcinoma",[498,499,500,501,502,503,504,505],"relapsed or refractory HPV-related oropharyngeal cancer","human papilloma virus-related cancer","HPV-related head and neck cancer","HPV-related oropharyngeal cancer","cell therapy","adoptive cell therapy","NEXI-003","Head and neck cancer","2024-01-12",{"date":508,"type":91},"2024-01-16",{"date":449,"type":22},{"date":511,"type":22},"2027-08-25",{"name":513,"class":514},"NexImmune Inc.","INDUSTRY",{"id":516,"slug":517,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":538},"100468091","immune-biomarker-study-for-head-and-neck-cancer-100468091","NCT05375266","Immune Biomarker Study for Head and Neck Cancer","ImmunBio-KHT","Inclusion Criteria:\n\n* Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC II-IVB (study group)\n* Diseases other than malignant diseases (patients with the indication for surgery of the ear, nose nose or maxillofacial surgery) (control group)\n* Absence of a currently existing or previous malignant disease regardless of the anatomical localization (control group)\n* Agreement of the patients for sampling blood, saliva and stool as well as consent to the preservation of all samples for further study purposes\n* Age ≥ 18 years\n* Cognitive ability of the patients to understand the meaning and purpose of the study and agree to it\n\nExclusion Criteria:\n\n* Distant metastases and \u002F or simultaneous secondary carcinoma at the time of diagnosis (= inclusion date)\n* Carcinomas in which it is (likely) impossible to take a sample without interfering with the further pathological assessment\n* Present drug abuse\n* Patients who are unable or unwilling to behave and receive treatment according to protocol\n* Patients who are legally patronized\n* Patients who are not eligible for participation in the study due to language barrier",{"count":523,"type":22},1100,"The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.",[228,55,57,52,53],[527,528],"Immunologic markers","Immunotherapy","2023-05-16",{"date":531,"type":91},"2023-05-17",{"date":533,"type":91},"2022-05-16",{"date":535,"type":22},"2027-03-31",{"name":537,"class":98},"University of Erlangen-Nürnberg Medical School",3,{"id":540,"slug":541,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":111,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":335},"100364002","phase-3-assessment-of-swallowing-function-and-quality-of-life-in-oropharyngeal-cancer-patients-treated-by-chemo-radiotherapy-100364002","NCT04019548","Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy","Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy","SwallPEG","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. ECOG performance status ≤ 2\n3. Female and Male\n4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx\n5. Candidate for curative intent radiotherapy and systemic treatment\n6. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)\n7. Diagnosis biopsy results\n8. HPV\u002Fp 16 testing results\n9. Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.\n10. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.\n11. Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.\n12. Adequate bone marrow function as defined below:\n\n    * Absolute neutrophil count (ANC) ≥1500\u002FµL or 1.5x109\u002FL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Platelets ≥100000\u002FµL or 100x109\u002FL\n13. Adequate liver function as defined below:\n\n    * Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \\\u003C 3 x UNL is allowed\n    * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n14. Adequate renal function as defined below:\n\n    * Creatinine ≤ 1.5 x UNL and creatinine clearance \\> 60 mL\u002Fmin\n15. Peripheral neuropathy ≤ grade 1\n16. Hear impaired ≤ grade 1\n17. Completion of all necessary screening procedures within 15 days prior to randomisation.\n18. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n19. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening\n\nExclusion Criteria:\n\n1. Severe malnutrition\n2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\\_v.5)\n3. Distant metastasis\n4. Serious coagulation disorders (INR\\>1.5, PTT\\>50s, platelets \\\u003C50000\u002Fmm3)\n5. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n6. Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal\u002Fsquamous cell carcinoma of the skin;\n7. Pregnant and\u002For lactating women.\n8. Known hypersensitivity to the study drug (cisplatin) or excipients.",{"count":548,"type":22},110,[113],"Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.\n\nStudy is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.\n\nAll subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).",[57],"2023-05-09",{"date":554,"type":91},"2023-05-10",{"date":556,"type":91},"2019-12-16",{"date":558,"type":22},"2030-05-01",{"name":560,"class":98},"Jules Bordet Institute"]