[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-cutaneous-squamous-cell-carcinoma-of-the-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-cutaneous-squamous-cell-carcinoma-of-the-head-and-neck":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,72],{"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":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100566967","remote-audiometry-to-monitor-for-treatment-related-hearing-loss-in-patients-with-hn-scc-receiving-cisplatin-andor-radiation-100566967",false,"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)","ALL","18 Years",{"count":19,"type":20},118,"ESTIMATED","INTERVENTIONAL",[23],"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.",[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],"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","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 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","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 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 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Sinonasal Cancer AJCC v8","RECRUITING","2026-04-20",{"date":62,"type":63},"2026-04-23","ACTUAL",{"date":65,"type":63},"2025-03-12",{"date":67,"type":20},"2029-10-31",{"name":69,"class":70},"Emory University","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":71},"100560661","phase-2-pembrolizumab-for-the-treatment-of-locally-advanced-andor-recurrent-orbital-or-periocular-cutaneous-squamous-cell-carcinoma-100560661","NCT06580054","Pembrolizumab for the Treatment of Locally Advanced and\u002For Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma","Pembrolizumab for Orbital and Periocular Cutaneous Squamous Cell Carcinoma (cSCC)","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n* Histologically confirmed diagnosis of locally advanced or diffuse or recurrent orbital or periorbital cutaneous squamous cell carcinoma.\n* Female participants:\n\n  * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    * Not a woman of childbearing potential (WOCBP) as defined.\n    * A WOCBP who agrees to follow the contraception guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n* The participant provides written informed consent for the trial.\n* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Absolute neutrophil count (ANC) ≥ 1500\u002FuL.\n* Platelets ≥ 100000\u002FuL.\n* Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL.\n\n  * Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN.\n\n  * Creatinine clearance (CrCl) should be calculated per institutional standard.\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN.\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases).\n* International normalized ratio (INR) OR prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n* Have recovered from toxicities and\u002For complications from any prior major surgery before starting study treatment.\n* Have a life expectancy of at least 12 weeks.\n* Patients with human immunodeficiency virus (HIV) adequately controlled on antiretroviral therapy.\n* Patients with known hepatitis B infection (defined as hepatitis B surface antigen \\[HbsAg\\] reactive) should be on suppressive anti hepatitis B virus (HBV) therapy, and patients with history of hepatitis C infection (defined as hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] detected) must complete curative antiviral treatment with HCV viral load below limit of quantification. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n\nExclusion Criteria:\n\n* Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study.\n* A WOCBP who has a positive pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required.\n* 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 T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment. Participants must have recovered from all adverse events (AEs) due to previous therapies to ≤ grade 1 or baseline. Participants with ≤ grade 2 neuropathy may be eligible.\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed.\n* Is currently participating in or has participated in a study of an investigational agent or has used an interventional investigational device within 4 weeks prior to the first dose of study intervention. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n* 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.\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers like ocular surface squamous cell neoplasia.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n* Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients.\n* 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.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a known history of active tuberculosis (TB) (bacillus tuberculosis).\n* 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.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* 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.\n* Has had an allogenic tissue (e.g., hematopoietic stem cell transplant \\[HSCT\\])\u002Fsolid organ transplant.\n* Has a history of any of the following cardiovascular conditions:\n\n  * Myocardial infarction within 6 months of enrollment.\n  * Active unstable angina.\n  * Congestive heart failure (≥ New York Heart Association Classification Class II)\n  * Cerebral vascular accident\u002Fstroke within 6 months of enrollment.\n  * Serious cardiac arrhythmia requiring medication. The classification of \"serious\" is at the discretion of the investigator.",{"count":80,"type":20},22,[82],"PHASE2","This phase II trial studies how well pembrolizumab works in treating patients with orbital (eye socket) and\u002For periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Skin cancers that are close to the eye or on the eyelid often have more genetic (heredity) changes than other types of cancers. This means that the deoxyribonucleic acid (DNA) (the building blocks of the body that determine such things as the color of the hair) in tumor tissue has been altered compared to normal tissue. It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called 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. Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable (responsive) to cure by surgery or radiation. Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital and\u002For periorbital cSCC.",[85,44,86],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","2026-03-09",{"date":89,"type":63},"2026-03-11",{"date":91,"type":63},"2025-03-05",{"date":93,"type":20},"2030-03-01",{"name":95,"class":70},"University of Michigan Rogel Cancer Center"]