[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc-v8":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,64,104,149,172,199],{"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":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100449723","phase-2-bicazo-a-study-combining-two-immunotherapies-cabozantinib-and-nivolumab-to-treat-patients-with-advanced-melanoma-or-squamous-cell-head-and-neck-cancer-an-immunomatch-pilot-study-100449723",false,"NCT05136196","BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study","Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study","Inclusion Criteria:\n\n* STEP 1 - SPECIMEN SUBMISSION\n* Participants must have histologically confirmed melanoma that is stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is either locally recurrent and non-amendable to curative therapy (e.g., radiation, surgery) or metastatic. The primary tumor location must be the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or unknown primary tumor are not eligible\n\n  * Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration\n* Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step 2 registration\n* Participants must have had documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving checkpoint inhibition for a minimum of 6 weeks. Participants who recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment are eligible if they have measurable disease and are considered unresectable\n* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to step 1 registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to step 1 registration\n* Participants with a history of hepatitis C virus (HCV) infection must have no detectable viral load within 28 days prior to step 1 registration\n* Participants must not have an active infection requiring systemic therapy (except HBV, HCV or HIV as mentioned above)\n* Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days prior to step 1 registration, unless clinically stable with ongoing medical management\n* Participants must have recovered to baseline or =\\\u003C grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments, unless adverse events are deemed clinically nonsignificant by the treating investigator or stable on supportive therapy\n* Participants must not have received more than one prior primary radiotherapy regimen, curative or adjuvant, to the mucosal surfaces of the head and neck, with the additional following criteria:\n\n  * If the primary radiation is combined with chemotherapy, a minimum of 16 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration. If the radiation is given alone, a minimum of 8 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration\n  * Additional palliative radiotherapy regimens are permitted but cannot have been administered to previously treated tissue (i.e., overlapping fields are excluded) with the exception of central nervous system (CNS) radiation and must be completed at least 4 weeks prior to step 1 registration\n  * Treatment areas should be healed with no sequelae from radiation therapy (RT) that would predispose to fistula formation\n* Participants must not have received prior treatment with anti-VEGF therapies for any reason\n* Participants must be \\>= 18 years of age\n* Participants must have a Zubrod Performance Status 0 or 1\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better to be eligible for this trial\n* Participants must not have any known significant organ disfunction that, in the opinion of the treating investigator, may impact suitability for receiving combination nivolumab\u002Fcabozantinib treatment\n* Participants must be able to take oral medication without breaking, opening, crushing, dissolving or chewing capsules\n* Participants must not have malabsorption syndrome\n* Participants must not have active autoimmune disease requiring systemic steroids (equivalent of \\> 10mg of prednisone) or other immune suppression. Exceptions:\n\n  * Type 1 diabetes mellitus\n  * Endocrinopathy only requiring hormone replacement\n  * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n  * Conditions not expected to recur in the absence of an external trigger\n* Participants must not have received an organ allograft\n* Participants must not have a history of hemoptysis (defined as \\>= 1\u002F2 tsp of bright red blood per day) or tumor bleeding within 90 days prior to step 1 registration\n* Participants must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with cabozantinib therapy:\n\n  * Prior carotid bleeding\n  * Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies\n  * Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies\n  * Any prior history of bleeding related to the current head and neck cancer\n  * History of gross hemoptysis (bright red blood of 1\u002F2 teaspoon or more per episode of coughing) within 3 months\n* Participants must not require concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)\n\n  * Participants must not require anticoagulants except for the following:\n\n    * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors, rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to step 1 registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* Participants must not have evidence of preexisting uncontrolled hypertension 28 days prior to step 1 registration as documented by baseline blood pressure reading with systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 90 mmHg. Participants on antihypertensive therapies with controlled blood pressure are eligible\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing due to the known safety profiles of the drugs in this study. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential\". In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion and vasectomy with testing showing no sperm in the semen\n* Have an adequate archival tissue specimen verified by the local pathologist and documented on the Pathology Review Form from a procedure obtained after the development of resistance to anti-PD-1\u002FL1 therapy. Archival tissue must consist of tumor block or at least 1 hematoxylin and eosin (H\\&E)-stained 4-5 micron slide and 20 freshly cut serially sectioned and numbered 4-5 micron unstained, uncharged slides OR\n\nBe willing to undergo research biopsy AND have tumor accessible for biopsy based on the following criteria:\n\n* Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies can be obtained incidentally to a clinically necessary procedure and NOT for the sole purpose of the clinical trial\n* Acceptable biopsy procedures are:\n\n  * Percutaneous biopsy with local anesthetic and\u002For sedation with an expected risk of severe complications \\\u003C 2%\n  * Direct transoral biopsy (with or without local anesthetic and\u002For sedation) with an expected risk of severe complications \\\u003C 2%\n  * Excisional cutaneous biopsy with local anesthetic and\u002For sedation with an expected risk of severe complications \\\u003C 2%\n  * Biopsy with removal of additional tumor tissue during a medically necessary mediastinoscopy, laparoscopy, gastrointestinal endoscopy, bronchoscopy or craniotomy. No open surgical, laparoscopic or endoscopic procedure should be performed solely to obtain a biopsy for this protocol\n  * Removal of additional tumor tissue during a medically necessary surgical procedure\n\n    * Participants must submit whole blood for germline genomic analysis\n    * Participants must have been offered the opportunity to participate in specimen banking\n    * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\n\n  * STEP 2 TREATMENT REGISTRATION\n* Note: No tests or exams are required to be repeated for step 2 registration (Treatment). However, participants who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration\n\n  * Participants must continue to meet eligibility for step 1 registration prior to step 2 registration\n  * Participants must have had their tumor tissue submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System prior to step 2 registration\n  * Participants registered during stage II of the protocol must have received assignment to an open cohort from the SWOG Statistics and Data Management Center based on their biomarker screening profile (not applicable for patients registered during stage I of the protocol)\n  * Participants must have measurable disease. All measurable disease must be assessed within 28 days prior to step 2 registration. All non-measurable disease must be assessed within 42 days prior to step 2 registration. Note: All disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n  * For melanoma participants, CT chest, abdomen and pelvis must be obtained. For HNSCC participants, CT neck and chest must be obtained. Further imaging (i.e., MR brain, CT abdomen\u002Fpelvis or extremities, bone scan) will be performed as deemed appropriate by the treating physician\n  * Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy\n  * Participants must not have experienced any significant health changes that, in the opinion of the treating investigator, may impact continued suitability for receiving combination nivolumab\u002Fcabozantinib treatment\n  * Participants with treated brain metastases must have discontinued steroid treatment at least 14 days prior to step 2 registration\n  * Participants must not have received investigational agents or monoclonal antibodies (except Food and Drug Administration \\[FDA\\] approved supportive care antibodies, such as denosumab) within 28 days prior to step 2 registration\n  * Participants must not have received surgery, chemotherapy, radiation therapy, biologic agents, or steroids within 14 days prior to step 2 registration\n  * Participants must not have received administration of a live, attenuated vaccine within 30 days prior to step 2 registration. Note: Participants may have received a messenger ribonucleic acid (mRNA) or viral vector-based coronavirus disease 2019 (COVID-19) vaccine within 30 days prior to step 2 registration\n  * Participants must not have received administration of any strong CYP3A4 inducers, such as but not limited to rifampin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort, within 14 days prior to step 2 registration\n  * Participants must not have received administration of any strong CYP3A4 inhibitors, such as but not limited to clarithromycin, itraconazole, ketoconazole, grapefruit juice, indinavir, nelfinavir, ritonavir, nefazodone, saquinavir, and telithromycin, within 5 times the half-life of the CYP3A inhibitor prior to step 2 registration\n  * Participants must have a history and physical examination performed within 28 days prior to step 2 registration\n  * Leukocytes \\>= 3,000\u002FuL (within 28 days prior to step 2 registration)\n  * Absolute neutrophil count \\>= 1,500\u002FuL (within 28 days prior to step 2 registration)\n  * Platelets \\>= 100,000\u002FuL (within 28 days prior to step 2 registration)\n  * Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) or =\\\u003C 3 x ULN for participants with Gilbert's disease (within 28 days prior to step 2 registration)\n  * Aspartate aminotransferase (AST) =\\\u003C 3 x institutional ULN (within 28 days prior to step 2 registration)\n  * Alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN (within 28 days prior to step 2 registration)\n  * Urinalysis: For baseline value (no required value for eligibility)\n  * Measured (OR calculated) creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 registration","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are \"tumor mutational burden\" and \"tumor inflammation signature.\" Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.",[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],"Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma","Locally Recurrent Laryngeal Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oropharyngeal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Melanoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Recurrent Melanoma","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma 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 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Unresectable Melanoma","RECRUITING","2026-06-25",{"date":54,"type":55},"2026-06-26","ACTUAL",{"date":57,"type":55},"2022-12-06",{"date":59,"type":20},"2027-01-01",{"name":61,"class":62},"National Cancer Institute (NCI)","NIH",223,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100592718","phase-2-methotrexate-erlotinib-and-celecoxib-for-the-treatment-of-recurrentmetastatic-head-and-neck-cancer-in-a-rural-midwest-united-states-population-100592718","NCT06997068","Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent\u002FMetastatic Head and Neck Cancer in a Rural Midwest United States Population","MC240701 Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent\u002FMetastatic Head and Neck Cancer in a Rural Midwest United States Population","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed diagnosis of relapsed\u002Fmetastatic head and neck cancer, including oral cavity, oropharynx \\[human papillomavirus (HPV) positive and negative), hypopharynx, and larynx cancer\n* Measurable or non-measurable disease is allowed\n\n  * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n  * Non-measurable disease\n\n    * NOTE: Other nonmeasurable lesions include clinically evident lesions not well visualized on imaging \\[e.g., oral cavity mass readily seen on physical exam but obscured on computed tomography (CT)\\], dermal metastases, and bone metastases\n* Prior treatment:\n\n  * One of the following must be true:\n\n    * Received standard 1st-line immunotherapy or chemo-immunotherapy OR\n    * Unable to receive or refuse 1st-line therapy\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin per Chronic-Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation (obtained 15 days prior to registration)\n* Estimated creatinine clearance (Clcr) by the CKD-EPI Creatinine Equation (per National Kidney Foundation) (obtained 15 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Ability to swallow pills\n* Willing and able to adhere with the protocol schedule for the duration of the study including undergoing treatment, attending scheduled visits, and examinations\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Myocardial infarction ≤ 6 months prior to registration\n  * New York Heart Association (NYHA) class III or IV heart failure\n  * Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females\n  * Uncontrolled dysrhythmias or poorly controlled angina\n  * History of serious ventricular arrhythmia \\[ventricular tachycardia (VT) or ventricular flutter (VF)\\] and\u002For factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome)\n  * Ongoing or active infection requiring systemic treatment\n  * Active gastrointestinal bleeding\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Known hepatitis\n\n  * Exception: For patients with evidence of chronic hepatitis B virus infection the hepatitis B (HepB) viral load must be undetectable on suppressive therapy, if indicated, to be eligible\n  * Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria\n\n  * NOTE: Patients with secondary malignancy with life expectancy ≥ 2 years are eligible\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens",{"count":72,"type":20},25,[23],"This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving the combination of methotrexate, erlotinib, and celecoxib may be feasible, safe, and effective in treating rural Midwest patients with recurrent\u002Fmetastatic head and neck cancer.",[76,77,78,79,80,81,29,82,83,84,85,86,87,88,89,90,91,92],"Metastatic Oral Cavity Carcinoma","Recurrent Oral Cavity Carcinoma","Stage IVC Lip and Oral Cavity Cancer AJCC v8","Head and Neck Cancer","Hypopharynx Cancer","Oropharynx Cancer","Metastatic Hypopharyngeal Carcinoma","Metastatic Laryngeal Carcinoma","Metastatic Malignant Head and Neck Neoplasm","Metastatic Oropharyngeal Carcinoma","Recurrent Hypopharyngeal Carcinoma","Recurrent Laryngeal Carcinoma","Recurrent Malignant Head and Neck Neoplasm","Recurrent Oropharyngeal Carcinoma","Stage IVC Hypopharyngeal Carcinoma AJCC v8","Stage IVC Laryngeal Cancer AJCC v8","Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8","2026-05-07",{"date":95,"type":55},"2026-05-11",{"date":97,"type":55},"2025-07-09",{"date":99,"type":20},"2028-06-30",{"name":101,"class":102},"Mayo Clinic","OTHER",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":115,"conditions":116,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"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":112,"type":20},118,[114],"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.",[29,117,118,119,120,121,122,35,36,37,123,39,40,124,125,126,127,128,129,130,131,132,133,134,135,136,137,46,47,48,138,49,139],"Cutaneous Squamous Cell Carcinoma of the Head and Neck","Head and Neck Carcinoma of Unknown Primary","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck","Metastatic Nasopharyngeal Squamous Cell Carcinoma","Metastatic Paranasal Sinus Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Paranasal Sinus Squamous Cell Carcinoma","Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck","Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Nasopharyngeal Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Recurrent Paranasal Sinus Squamous Cell Carcinoma","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8","Stage IV Sinonasal Cancer AJCC v8","2026-04-20",{"date":142,"type":55},"2026-04-23",{"date":144,"type":55},"2025-03-12",{"date":146,"type":20},"2029-10-31",{"name":148,"class":102},"Emory University",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":103},"100543469","oropharynx-opx-biomarker-trial-100543469","NCT06356272","Oropharynx (OPX) Biomarker Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to provide written consent\n* Groups 1-3:\n\n  * Must undergo p16 staining on biopsy for enrollment\n  * Patients with \\\u003C 70% of tumor cells positive for p16 will be considered p16 negative\n  * Must undergo HPV16 family in situ hybridization (ISH) and\u002For RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it\n  * Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol\n* Group 4:\n\n  * Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm\n\n    * Primary salivary neoplasm\n    * Primary thyroid neoplasm\n    * Primary head and neck neoplasm\n    * Multi-cancer early detection (MCED) testing concerning for cancer\n* Patient has given permission to give his\u002Fher tumor\u002Ftissue\u002Fblood\u002Fsaliva sample for research testing\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Primary language: English, Spanish, Arabic\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.\n* Groups 1-3:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3)\n    * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the tumor for which they are being treated\n* Group 4, Cohort A, B, C:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma\n    * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the present neoplasm\n  * Note these are clarifications of inclusion into Group 4, Cohorts D and E:\n\n    * Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm\n    * Receipt of cancer specific therapy for other malignancy is allowed in this arm",{"count":156,"type":20},560,"OBSERVATIONAL","The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent.",[27,29,40,127,135,45,49,160,161,162,163],"Head and Neck Carcinoma","Head and Neck Neoplasm","Salivary Gland Neoplasms","Thyroid Gland Neoplasm","2026-04-17",{"date":166,"type":55},"2026-04-22",{"date":168,"type":55},"2019-11-15",{"date":170,"type":20},"2029-11-30",{"name":101,"class":102},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100582832","phase-1-tmv-vaccine-therapy-alone-and-with-pembrolizumab-for-the-treatment-of-recurrent-andor-metastatic-head-and-neck-squamous-cell-cancer-100582832","NCT06868433","TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and\u002For Metastatic Head and Neck Squamous Cell Cancer","Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and\u002For Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Must be at least ≥ 18 years of age\n* Histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to salvage surgery. p16 positive and negative allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal carcinoma and cancer of unknown primary (squamous cell carcinoma only) are all allowed. They will be allowed to have up to 3 different regimens after diagnosed of recurrent or metastatic HNSCC\n* Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done\n* The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form \\[ICF\\] must be signed)\n* Recurrent and\u002For metastatic HNSCC that has failed standard chemotherapy and immunotherapy. Eligible subjects must have progressed on ≥ 2 lines of standard of care prior to starting trial therapy. For patients who have relapsed within 6 months of systemic therapy given with curative intent, that therapy will count as a line of metastatic therapy. Eligible subjects will have no restriction on prior lines of therapy in the metastatic\u002Fadvanced disease setting\n* The tumors should be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Must have enough tissue collected after salvage surgery to make at least 3 doses of vaccine (minimum weight of the resectable tumor tissue is ≥ .5 grams) and adequate cellularity (\\> 40% cellularity) assessed by the head and neck pathologists\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* Absolute neutrophil count ≥ 1,500 cells\u002FuL\n* Platelets ≥ 100,000\u002FuL\n* Hemoglobin ≥ 9.0g\u002FdL (may receive packed red blood cell \\[prbc\\] transfusion)\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Albumin ≥ 3.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN\n* Calculated creatinine clearance of ≥ 50 mL\u002Fmin\n* International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving low molecular weight (LMW) heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \\\u003C 1.1U\u002FmL are allowed on the trial\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Ability to understand and willingness to sign written informed consent documents\n* Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion\n* Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion\n* Female subjects of childbearing age must have a negative serum pregnancy test at study entry\n* Patients who have received prior pembrolizumab are eligible\n\nExclusion Criteria:\n\n* Salivary tumors and non-squamous cell histology in head and neck cancer\n* Not enough tissue collected after surgery for a planned 3 doses (weight of the resectable tumor tissue is less than 1.0 gram)\n* Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)\n* Prior organ allograft or allogeneic bone marrow transplantation\n* Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma\u002Fatopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Women who are pregnant or lactating, and child-bearing potential women without adequate contraception\n* Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Other medications, or severe acute\u002Fchronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study\n* Clinical evidence of bleeding diathesis or coagulopathy\n* Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for \\> 5 years. Patients with prior in situ carcinomas are eligible provided there was complete removal\n* Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment\n* Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Non-oncology vaccines within 28 days prior to planned treatment",{"count":180,"type":20},40,[182],"PHASE1","This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and\u002For effective in treating patients with recurrent and\u002For metastatic head and neck squamous cell cancer.",[29,35,36,37,123,39,40,185,130,131,132,133,134,135,186,187,137,46,47,48,138,49,139],"Metastatic Sinonasal Squamous Cell Carcinoma","Recurrent Sinonasal Squamous Cell Carcinoma","Squamous Cell Carcinoma of Unknown Primary",[189],"Recurrent or metastatic head and neck cancer whose tumor should have banked at the time of surgery.","2026-03-02",{"date":192,"type":55},"2026-03-04",{"date":194,"type":55},"2025-05-08",{"date":196,"type":20},"2028-12-31",{"name":148,"class":102},2,{"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":209,"conditions":210,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":218,"locationsCount":198},"100565019","phase-2-lovastatin-and-pembrolizumab-for-the-treatment-of-patients-with-recurrent-or-metastatic-head-and-neck-cancer-lapp-trial-100565019","NCT06636734","Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial","A Phase II Trial Of Lovastatin And Pembrolizumab In Patients With RM HNSCC (LAPP)","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can be included if human papillomavirus (HPV)-positive\n* PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)\n* Patients must not be under consideration for salvage surgery\n* Measurable disease by RECIST 1.1 criteria\n* Life expectancy of more than 3 months, as determined by the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 from toxicities related to any prior treatments, unless adverse events are clinically non-significant and\u002For stable on supportive therapy\n* For men or women of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of lovastatin\u002Fpembrolizumab administration\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 without colony stimulating factor support\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002FdL\n* Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL\n* Serum albumin ≥ 2.8 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN\n* Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)\n\nExclusion Criteria:\n\n* Patients already taking a statin drug\n* Liver dysfunction precluding the use of statins\n* Radiation to the head and neck or other sites within 4 weeks prior to enrollment\n* Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment\n* Prior treatment with immune checkpoint blocking therapy\n* Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)\n* Pregnancy, lactation, or plan to become pregnant\n* Inability to swallow lovastatin tablets\n* Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab",{"count":207,"type":20},28,[23],"This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.",[29,211,35,36,37,123,39,40,124,130,131,132,133,134,135,136,46,47,48,138,49,139],"Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary","2026-02-08",{"date":214,"type":55},"2026-02-11",{"date":216,"type":55},"2024-12-09",{"date":196,"type":20},{"name":148,"class":102}]