[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypopharyngeal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypopharyngeal-squamous-cell-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,80,104,132,163,199,242,269,290],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100556989","phase-2-testing-the-addition-of-the-drug-bmx-001-a-radioprotector-or-a-placebo-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer-100556989",false,"NCT06532279","Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer","A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation","Inclusion Criteria:\n\n* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.\n* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \\>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \\>= 50 Gy must be documented by the enrolling physician.\n* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.\n* P16 and\u002For human papillomavirus (HPV) status (via polymerase chain reaction \\[PCR\\] or in situ hybridization \\[ISH\\]) must be documented for patients with oropharynx cancer.\n* No patients with T0\u002FTx\u002Funknown primary disease.\n* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.\n* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.\n* Age \\>= 18.\n* Zubrod performance status of 0-2.\n* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable).\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN.\n* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa\u002Flevel 4 neck.\n* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.\n* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.\n* No current treatment of adjuvant post-operative (op) chemoradiation.\n* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\\\u003C 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.\n* No prior induction chemotherapy treatment.\n* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.\n* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.\n* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).\n* No valvular heart disease.\n* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.\n* No history or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.\n* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.\n* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \\[EKGs\\] in prior 3 months of a QTc interval \\> 450 milliseconds (ms) for males and \\> 470 ms for females using the specific\u002Fusual choice by clinical center for correction factor.\n* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.\n* No poorly controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160 and\u002For diastolic blood pressure \\[DBP\\] \\> 95) over 2 repeated measures within 30 days prior to registration.\n* No grade \\>= 2 oral mucositis per CTCAE version 5.0.\n* No grade \\>= 2 hypotension per CTCAE v. 5.0.\n* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.\n* No medical necessity for medications listed as prohibited.\n\n  * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer\u002FInternational Society of Oral Oncology (MASCC\u002FISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.\n  * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.","ALL","18 Years",{"count":19,"type":20},98,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage 0 Hypopharyngeal Carcinoma AJCC v8","Stage 0 Nasopharyngeal Carcinoma AJCC v8","Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage I Hypopharyngeal Carcinoma AJCC v8","Stage I Laryngeal Cancer AJCC v8","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stomatitis","RECRUITING","2026-06-22",{"date":70,"type":71},"2026-06-25","ACTUAL",{"date":73,"type":71},"2025-06-23",{"date":75,"type":20},"2027-01-01",{"name":77,"class":78},"NRG Oncology","OTHER",153,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100644115","phase-2-neoadjuvant-egfr-adc-combined-with-anti-pd-1-monoclonal-antibody-in-resectable-locally-advanced-hypopharyngeal-squamous-cell-carcinoma-100644115","NCT07665190","Neoadjuvant EGFR-ADC Combined With Anti-PD-1 Monoclonal Antibody in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","A Multicenter, Phase II Clinical Trial of Neoadjuvant Becotatug Vedotin Combined With Pucotenlimab in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","RESERVE-HC","Inclusion Criteria:\n\n1. Aged ≥ 18, male or female;\n2. Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma;\n3. Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition);\n\n3\\. Measurable primary lesions per RECIST v1.1; 5.Treatment-naive (no prior anti-tumor therapy for current disease); 6.ECOG performance status 0-1; 7.Estimated life expectancy \\>= 3 months; 8.Have adequate organ function as defined by laboratory parameters; 9.No contraindications to chemotherapy, targeted therapy, or immunotherapy; 10.No history of immune-related diseases; 11.No uncontrolled pneumonia or pulmonary infection; 12.Female participants of childbearing potential must agree to use effective contraception during the trial; A serum or urine pregnancy test must be negative within 72 hours prior to the start of chemotherapy; 13.The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis;\n2. Patients with uncontrolled severe medical conditions;\n3. Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;\n4. Uncontrolled cardiac clinical symptoms or diseases;\n5. Occurrence of severe infection (CTCAE Grade \\> 2) within 4 weeks prior to the first dose of the study drug;\n6. Unexplained fever \\> 38.5°C during the screening period or before the first dose;\n7. Active autoimmune disease or a history of autoimmune disease;\n8. History of immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation;\n9. Patients with untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA exceeding 500 IU\u002FmL, or patients with active hepatitis C virus (HCV) must be excluded;\n10. History of interstitial lung disease;\n11. Patients with active pulmonary tuberculosis infection identified by medical history or CT scan;\n12. Patients who have received any of the following treatments:\n\n    A. Receipt of any investigational drug or anti-cancer therapy within 4 weeks prior to the first dose of the study drug; B. Requirement for systemic treatment with corticosteroids (daily dose \\> 10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of the study drug.; C. Prior vaccination with an anti-tumor vaccine or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug; D. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug; E. Concurrent enrollment in another clinical study;\n13. Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires;\n14. Subjects with peripheral neuropathy ≥ Grade 2 according to CTCAE V5.0;\n15. History of allergy or hypersensitivity to any component of the study treatment;\n16. History of a primary malignancy other than head and neck squamous cell carcinoma within the previous 5 years;\n17. Requirement for concurrent treatment with other anti-tumor therapies;\n18. Patients deemed unsuitable for enrollment by the investigator;\n19. Pregnant or breastfeeding women.",{"count":89,"type":20},52,[23],"This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma.\n\nThe primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.",[30],"NOT_YET_RECRUITING","2026-06-18",{"date":96,"type":71},"2026-06-24",{"date":98,"type":20},"2026-07-01",{"date":100,"type":20},"2030-12-31",{"name":102,"class":78},"Tianjin Medical University Cancer Institute and Hospital",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":131},"100265421","phase-2-radiation-therapy-with-or-without-cisplatin-in-treating-patients-with-stage-iii-iva-squamous-cell-carcinoma-of-the-head-and-neck-who-have-undergone-surgery-100265421","NCT02734537","Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery","Phase II Randomized Trial of Radiotherapy With or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) With TP53 Sequencing","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0)\n* Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified \\[NOS\\]) of the head\u002Fneck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer \\[AJCC\\] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0\n* Patient has undergone total resection of the primary tumor with curative intent\n\n  * NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days\n* For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)\n* Patients with, per the operative and\u002For pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and\u002For gross residual disease after surgery are not eligible\n* A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration\n\n  * NOTE: Complete the EA3132-specific FoundationOne requisition form\n* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and\u002For non-melanomatous skin cancer; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor\n* Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease\n* Patients with recurrent disease or multiple primaries are ineligible\n* RANDOMIZATION (STEP 1)\n* NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion\n* Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization\n* The patient must have the following assessments done =\\\u003C 8 weeks prior to randomization:\n\n  * Examination by a head and neck surgeon\n  * Chest x-ray (or chest computed tomography \\[CT\\] scan or CT\u002Fpositron emission tomography \\[PET\\] of the chest or magnetic resonance imaging \\[MRI\\]) to rule out distant metastatic disease\n* Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization\n* Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3 within 4 weeks prior to randomization\n* Platelets \\>= 100,000\u002Fmm\\^3 within 4 weeks prior to randomization\n* Total bilirubin =\\\u003C the upper limit of normal (ULN) within 4 weeks prior to randomization\n* Calculated creatinine clearance must be \\> 60 ml\u002Fmin using the Cockcroft-Gault formula within 4 weeks prior to randomization\n* Patient must not have an intercurrent illness likely to interfere with protocol therapy",{"count":112,"type":20},189,[23],"This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.",[29,30,31,116,117,118,52,53,54,119,56,57,58,59,120,61],"Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant","Lip and Oral Cavity Squamous Cell Carcinoma","p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma","Stage III Oral Cavity Verrucous Carcinoma","Stage IVA Oral Cavity Verrucous Carcinoma","2026-06-16",{"date":123,"type":71},"2026-06-17",{"date":125,"type":71},"2016-11-23",{"date":127,"type":20},"2027-12-31",{"name":129,"class":130},"ECOG-ACRIN Cancer Research Group","NETWORK",676,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":162},"100591408","phase-2-testing-whether-cemiplimab-regn2810-plus-cdx-1140-given-prior-to-surgery-are-better-than-cemiplimab-regn2810-alone-in-patients-with-stage-iii-iv-head-and-neck-cancer-100591408","NCT06980038","Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer","A Phase 2 Window of Opportunity Trial of Neoadjuvant Agonistic Anti-CD40 Antibody CDX-1140 and Cemiplimab (REGN2810) in AJCC Stage III-IV Head and Neck Cancer Patients Prior to Surgery","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed American Joint Committee on Cancer (AJCC) stage III-IV T0-4, N0-3b, M0 mucosal head and neck squamous cell carcinoma (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx, and nasal cavity) that is appropriate for surgical resection. Both previously untreated (primary) and recurrent (salvage) settings will be eligible. Tumors must be accessible to biopsy in clinic (patients with laryngeal, hypopharyngeal, nasal cavity and base of tongue tumors will have endoscopic biopsies)\n* For patients with oropharyngeal cancer, only p16-negative (non-human papillomavirus \\[HPV\\] related) patients will be eligible\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of cemiplimab (REGN2810) alone or in combination with CDX-1140 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin (Hb) ≥ 7 g\u002FdL (transfusion allowed to bring Hb to this level)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine ≤ 1.5 × institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Women of childbearing potential and men should use effective contraception during treatment with cemiplimab (REGN2810) and for 4 months after the last dose. The reproductive and developmental toxicity of CDX-1140 has not been evaluated. Women of childbearing potential and their partners who receive CDX-1140 must therefore take adequate contraceptive measures\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Active or documented history of autoimmune disease within 2 years before screening\n* Prior or planned allogeneic hematopoietic stem cell transplantation (HSCT)\n* History of organ transplant that requires use of immunosuppressive medications\n* Current or prior use of immunosuppressive medication within 14 days prior to the start of study drug administration. Immunosuppressants may interfere with study drug efficacy\n* Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab (REGN2810). It is unclear how prior exposure to immunotherapy would impact future use of checkpoint inhibitors\n* Concurrent use of prednisone (10 mg or more)\n* Patients with new pulmonary infiltrates indicative of pneumonitis, history of (non-infectious) pneumonitis\u002Finterstitial lung disease, or current pneumonitis\u002Finterstitial lung disease, including grade 1 pneumonitis (i.e., asymptomatic, clinical or diagnostic observation only, intervention not indicated)\n* Another active malignancy for which the natural history or treatment has potential to interfere with the safety or efficacy assessment of the investigational regimen on this trial\n* Patients who have not recovered from AE due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents, such as concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1140 or cemiplimab (REGN2810)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Because of the potential for serious adverse reactions in breastfed children, women should not breastfeed during treatment with cemiplimab (REGN2810) and for at least 4 months after the last dose. These risks may also apply to CDX-1140",{"count":140,"type":20},44,[23],"This phase II trial compares the effectiveness of cemiplimab with CDX-1140 to cemiplimab without CDX-1140 prior to surgery in treating patients with stage III-IV head and neck cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1140 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving cemiplimab with CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed for patients with stage III-IV head and neck cancer.",[29,30,31,144,33,34,145,146,147,148,149,150,53,54,55,56,151,58,59,60,63,64],"Nasal Cavity Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Nasal Cavity Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","2026-05-29",{"date":154,"type":71},"2026-06-01",{"date":156,"type":71},"2026-05-27",{"date":158,"type":20},"2027-11-24",{"name":160,"class":161},"National Cancer Institute (NCI)","NIH",6,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100597462","phase-2-compartmentalized-postoperative-radiotherapy-in-head-and-neck-cancer-100597462","NCT07058805","Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer","COMPORT: Compartmentalization in Postoperative Radiotherapy for Head and Neck Squamous Cell Carcinoma - A Phase II Clinical Trial","COMPORT","Inclusion criteria\n\n1. ECOG performance status 0-2 at the time of registration\n2. ≥18 years of age\n3. Baseline assessments and documentation of toxicity using CTCAE v.5 and QoL using EORTC C30 and HN43 questionnaires.\n4. Histopathologically confirmed, surgically treated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx\n5. No previous neoadjuvant systemic therapy or previous neoadjuvant systemic therapy (chemotherapy, immunotherapy or combinations) is permitted only if its neoadjuvant use for locally advanced HNSCC is approved by Swissmedic and routinely reimbursed at the time it was administered or if it was administered as part of routine institutional treatment decisions, outside of a clinical trial or other investigational framework.\n6. Standard indication for PORT via external beam radiotherapy (with or without concomitant systemic treatment) defined by a multidisciplinary head and neck tumor board (MDT).\n7. History and physical examination by treating radiation oncologist within 28 days prior to registration.\n8. MRI of the head and neck (or computerized tomography as substitute) with i.v. contrast, if not contraindicated. CT of the chest with i.v. contrast, if not contraindicated. 18FDG-PET\u002FCT can be used instead of CT of the chest. The baseline imaging examinations include the preoperative diagnostic phase and do not have to be repeated if performed within 60 days prior to the enrollment.\n9. The multidisciplinary team (MDT) must determine that the patient can safely undergo the standard treatment, which may include PORT with or without additional systemic treatment.\n10. Post-menopausal women, or women of child-bearing potential who use or agree to use effective contraception, are not pregnant and agree not to become pregnant during and within 30 days after PORT. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during and within three months after PORT.\n11. Written informed consent, signed by the patient and the investigator.\n\nExclusion criteria\n\n1. Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer, or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active\u002Fprogressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).\n2. Presence of distant metastases c\u002FpM1.\n3. Neoadjuvant systemic therapy administered under a clinical trial protocol or as part of any structured investigational framework not considered standard institutional practice at the time of administration.\n4. Previous radiation dose applied to the anatomical sites overlapping with the standard PORT target volumes which may have a potential impact on the delivered dose and\u002For toxicity profile of the standard PORT.\n5. R2 resection of the primary tumor or any involved lymph node.\n6. Last oncologic surgery for the index HNSCC performed more than 6 weeks ago.\n7. Inadequate reporting of the pathology not conformal with COMPORT algorithm and no possibility of an adequate post-hoc acquisition of the necessary information (see the section 8)\n8. Co-existing disease prejudicing survival (expected survival less than 6 months).\n9. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n10. Illness expected to preclude PORT within 7 days of registration.\n11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n12. Ongoing participation in another interventional clinical trial which are not exempted by the sponsor. Exceptions may apply depending on the trial methodology (Please contact sponsor for clarification).",{"count":172,"type":20},50,[23],"COMPORT is a multicenter phase II clinical trial evaluating a personalized approach to postoperative radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC). The study investigates whether a risk-adapted, compartmentalized radiotherapy strategy can safely reduce the treatment volume, and thus the side effects, without increasing the risk of tumor recurrence. Eligible patients are those with surgically treated cancers of the oral cavity, oropharynx, larynx, or hypopharynx who have a standard indication for postoperative radiotherapy. The primary outcome is the rate of recurrence in anatomical compartments that would normally be irradiated but are intentionally omitted in this study. COMPORT aims to generate high-level evidence to support a more personalized and less toxic standard of care in postoperative head and neck cancer management.",[176,29,33,34,31,30],"Head and Neck Cancer",[176,178,179,180,181,182,183,184,185,186,187,188],"radiotherapy","Postoperative Radiotherapy","De-escalation","Compartmentalization","Phase II","Quality of life","Bayesian Analysis","TAME","EORTC QLQ-C30","EORTC QLQ-HN43","adjuvant treatment","2026-04-29",{"date":191,"type":71},"2026-05-06",{"date":193,"type":71},"2026-01-15",{"date":195,"type":20},"2029-04",{"name":197,"class":78},"Olgun Elicin",3,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":103},"100566967","remote-audiometry-to-monitor-for-treatment-related-hearing-loss-in-patients-with-hn-scc-receiving-cisplatin-andor-radiation-100566967","NCT06662058","Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and\u002For Radiation","Ototoxicity Monitoring and Remote Audiometry","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can also be included. Patients can have previously untreated or recurrent\u002Fmetastatic disease\n* Subjects who will be treated with cisplatin chemotherapy and\u002For radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and\u002For parotid salivary gland\n* Life expectancy of more than 3 months, as determined by the investigator\n\nExclusion Criteria:\n\n* Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report\u002Fhistory or audiogram done before or after informed consent\n* Patients who are unable to participate in a hearing test (per the investigator's judgment)",{"count":207,"type":20},118,[209],"NA","This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation.",[212,213,214,29,30,31,215,216,217,218,219,220,221,222,32,33,34,223,224,145,146,147,225,149,150,226,227,228,229,230,231,151,232],"Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Cutaneous Squamous Cell Carcinoma of the Head and Neck","Head and Neck Carcinoma of Unknown Primary","Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Nasopharyngeal Squamous Cell Carcinoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Metastatic Paranasal Sinus Squamous Cell Carcinoma","Paranasal Sinus Squamous Cell Carcinoma","Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck","Recurrent Nasopharyngeal Squamous Cell Carcinoma","Recurrent Paranasal Sinus Squamous Cell Carcinoma","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8","Stage IV Sinonasal Cancer AJCC v8","2026-04-20",{"date":235,"type":71},"2026-04-23",{"date":237,"type":71},"2025-03-12",{"date":239,"type":20},"2029-10-31",{"name":241,"class":78},"Emory University",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":257,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":265,"leadSponsor":267,"locationsCount":103},"100625472","phase-2-window-of-opportunity-in-preserving-laryngeal-function-trial-100625472","NCT07423078","Window of Opportunity in Preserving Laryngeal Function Trial","A Phase II Window of Opportunity in Preserving Laryngeal Function (WOLF) Trial","WOLF","Inclusion Criteria:\n\n1. Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx\n2. AJCC 8th Edition Stage III - IV disease (T1-T2\u002FN1-N3, T3-T4\u002FN0-N3)\n3. Disease (primary \\& nodal) must be potentially surgically resectable and curable with conventional surgery and CRT\n4. ECOG PS 0 - 2\n5. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for 1 year after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n7. Must have normal organ and marrow function as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count ≥ 1,500\u002FmcL\n   * Platelet count ≥ 100,000\u002FmcL\n   * Total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN)\n   * AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN)\n   * ALT (SGPT) ≤ 2.5 X institutional ULN\n   * Creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73 m2 for patients with a creatinine level above institutional normal\n8. Must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Prior treatment for head and neck cancer\n2. Unresectable laryngeal or hypopharyngeal squamous cell carcinoma\n3. Distant metastatic disease\n4. Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism or Sjogren's syndrome will not be excluded from the study.\n5. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n6. Known allergy or hypersensitivity to carboplatin or cisplatin, toripalimab, or paclitaxel.\n7. Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes for the patient.\n8. Peripheral sensory neuropathy \\> grade 2 by CTCAE v5.0\n9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n10. Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\]) or HIV infection (see note).\n\n    1. Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.\n    2. Note: Participants with a history of HIV infection are considered eligible if CD4+ T cell counts are ≥350 cells\u002FµL and the patient has had no opportunistic infections in the last 12 months.",{"count":251,"type":20},87,[23],"This trial will study the safety and tolerability and disease survival rates in adult patients with recurrent\u002Fmetastatic (R\u002FM) HNSCC when treated with carboplatin or cisplatin, paclitaxel, and toripalimab.",[255,256,30],"Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)","Locally Advanced Laryngeal Squamous Cell Carcinoma",[258,259,260],"immunotherapy","laryngectomy","neoadjuvant","2026-04-06",{"date":263,"type":71},"2026-04-13",{"date":261,"type":71},{"date":266,"type":20},"2031-04-30",{"name":268,"class":78},"Matthew Spector",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":103},"100586409","early-phase-1-comparing-an-investigational-scan-f-18-naf-petct-to-standard-of-care-imaging-f-18-fdg-petct-for-evaluating-vascular-complications-in-patients-receiving-radiation-therapy-for-head-and-neck-cancer-100586409","NCT06914999","Comparing an Investigational Scan (F-18 NaF PET\u002FCT) to Standard of Care Imaging (F-18 FDG PET\u002FCT) for Evaluating Vascular Complications in Patients Receiving Radiation Therapy for Head and Neck Cancer","Assessment of Radiation-Induced Vascular Complications in Patients With Head and Neck Cancers With PET\u002FCT Imaging","Inclusion Criteria:\n\n* Males and females 18 years of age and older\n* Diagnosis of clinical stage III-IVb (American Joint Committee on Cancer \\[AJCC\\] 8th edition) squamous cell carcinoma of the oropharynx (human papillomavirus \\[HPV\\]-negative), larynx, or hypopharynx, or clinical stage I-III (AJCC 8th edition) HPV-associated squamous cell carcinoma of the oropharynx receiving curative-intent, organ preservation (non-surgical)\n* Treatment with concurrent chemoradiotherapy per institutional standard of care at the discretion of Medical Oncology. RT is delivered per institutional standard of care at the discretion of Radiation Oncology\n* Patients must give protocol-specific consent on an Institutional Review Board (IRB)-approved consent form prior to completion of protocol-specific testing\u002Fprocedures\n* Women are eligible to participate in the study if they meet one of the following criteria:\n\n  * Females of childbearing potential (FCBP) must have a negative pregnancy test at baseline and follow-up visit. Women of childbearing potential must undergo pregnancy testing during each study visit and agree to use at least one of the following methods of contraception throughout the study duration:\n\n    * Oral contraceptives, transdermal contraceptives, injectable or implantable methods, intrauterine devices, and\u002For vaginal ring\n    * Women who are postmenopausal (for at least one year), sterile, or hysterectomized;\n    * Women who have undergone tubal ligation will be required to undergo pregnancy testing during each study visit\n\nExclusion Criteria:\n\n* Adults who are unable to consent\n* Pregnant women\n* Prisoners\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \\> grade 1)\n* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of the F-18 NaF for the pre-RT PET\u002FCT imaging\n* Patients planned to receive any immunotherapy agent during their radiotherapy or in the interval between radiotherapy and post-RT PET\u002FCT imaging\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to F-18 NaF or other agents used in the study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to study entry; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \\>= 3 hypertension (diastolic blood pressure \\>= 100 mmHg or systolic blood pressure \\>= 160 mmHg) despite antihypertensive therapy",{"count":277,"type":20},20,[279],"EARLY_PHASE1","This early phase I trial compares sodium fluoride F-18 (F-18 NaF) positron emission tomography (PET)\u002Fcomputed tomography (CT) to the standard of care imaging scan (and fludeoxyglucose F-18 \\[F-18 FDG\\] PET\u002FCT) for assessing the effects radiation therapy has on the blood vessels in the neck in patients with head and neck cancers. For people with cancers in the head and neck, doctors often use radiation to target both the tumor and nearby glands. Radiation therapy to this region can affect the blood vessels in the neck that supply blood to the brain. F-18 NaF and F-18 FDG are contrast agents that can be used together with PET\u002FCT imaging to visualize areas inside the body. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET\u002FCT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Imaging with F-18 NaF PET\u002FCT may be as effective or more effective than the standard F-18 FDG PET\u002FCT for assessing the effects radiation therapy has on blood vessels in the neck in patients with head and neck cancers.",[26,27,28,29,30,31,34,52,53,56,57,58,61,62,63,65],"2025-10-20",{"date":284,"type":71},"2025-10-22",{"date":286,"type":71},"2024-12-03",{"date":288,"type":20},"2027-08-31",{"name":241,"class":78},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":21,"phases":301,"briefSummary":302,"conditions":303,"keywords":314,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":5},"100526640","phase-2-european-larynx-organ-preservation-study-elos-mk-3475-c44-100526640","NCT06137378","European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]","ELOS - Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiation Compared to Additional PD-1 Inhibition in CPS ≥1 Advanced Laryngeal\u002FHypopharyngeal Cancer Suitable for Laryngectomy Selected After Early Response Evaluation","ELOS","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of the larynx or hypopharynx according to the decision of the multidisciplinary tumor board suitable for total laryngectomy can be enrolled in this study.\n2. Stage III, IVA or IVB, whenever clear resection margins R0 \\>5 mm can be achieved and no radiologic signs of extranodal extension of neck nodes are present.\n3. Have provided newly obtained excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n4. PD-L1-expression\\* within the tumor biopsy, CPS ≥1\n5. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Female participants:\n\n   A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation\u002Frandomization.\n8. Have adequate organ function as defined in the (Table 4) of the protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory receptor on T or NK cells (e.g., CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents.\n4. Has received prior radiotherapy.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n9. Has known distant metastases including active CNS metastases and\u002For carcinomatous meningitis.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.\n15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a known history of active TB (Bacillus Tuberculosis).\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.\n21. Has a known intolerance to one of the substances administered during treatment including e.g. antibiotics, antiemetics, etc. or any other component of concurrent auxiliary medication.","70 Years",{"count":300,"type":20},140,[23],"ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA\u002FB head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \\\u003C 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.",[304,30,305,306,307,308,309,310,31,311,312,313],"Squamous Cell Carcinoma of Head and Neck","Laryngeal Squamous Cell Carcinoma Stage III","Laryngeal Squamous Cell Carcinoma Stage IV","Squamous Cell Carcinoma of Larynx","Squamous Cell Carcinoma of the Larynx","Squamous Cell Carcinoma of the Larynx Stage III","Squamous Cell Carcinoma of the Larynx Stage IV","Laryngectomy; Status","Laryngeal Cancer","Laryngeal Neoplasms",[315,316,317,318,319,320,321,322,323],"induction chemotherapy","neoadjuvant treatment","immune checkpoint inhibitor","pembrolizumab","KEYNOTE","larynx organ preservation","laryngectomy-free survival","overall survival","event-free survival","2024-09-18",{"date":326,"type":71},"2024-09-20",{"date":328,"type":71},"2024-04-17",{"date":330,"type":20},"2030-12",{"name":332,"class":78},"University of Leipzig"]