[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-carcinoma-of-unknown-primary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-carcinoma-of-unknown-primary":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,65,121],{"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":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100452495","phase-1-testing-the-addition-of-ipatasertib-to-usual-chemotherapy-and-radiation-for-head-and-neck-cancer-100452495",false,"NCT05172245","Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer","Phase 1\u002F1b Study of AKT Inhibitor Ipatasertib With Chemoradiation for Locally Advanced Head and Neck Cancer","Inclusion Criteria:\n\n* Patients must have pathologically confirmed HNSCC (including tumors of the oropharynx, hypopharynx, larynx, oral cavity, nasal cavity, maxillary and other paranasal sinuses, and unknown primary of the head and neck), with measurable disease as per RECIST 1.1\n* Oropharyngeal and unknown primary squamous cell cancers must test for human papilloma virus (HPV), for example by p16 immunohistochemistry (IHC), in situ hybridization (ISH), or polymerase chain reaction (PCR). HPV testing is not required for other HNSCC primary tumor sites\n\n  * Patients with p16-positive tumors are eligible if clinical stage III (cT4 or cN3, M0) according to the American Joint Committee on Cancer (AJCC)\u002FTNM Staging System, 8th edition (Ed.)\n  * Patients with p16-negative (or not tested) tumors are eligible if clinical stage III-IVB (locally advanced but non-metastatic) according to the AJCC\u002FTNM Staging System, 8th Ed.\n* Must be candidate for concurrent, definitive cisplatin and radiation therapy as judged by the treating physician\n* Able to swallow tablets at the time of enrollment\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of ipatasertib in combination with chemoradiation in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Life expectancy of greater than 3 months\n* Absolute neutrophil count \\>= 3000\u002FmcL\n* Hemoglobin \\>= 10 g\u002FdL\n* Platelets \\>= 150,000\u002FmcL\n* Serum albumin \\>= 3 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN \u002F 2 x institutional ULN\n* Alkaline phosphatase (ALP) =\\\u003C 2.0 x institutional ULN\n* Partial thromboplastin time (PTT) (or activated \\[a\\]PTT) and international normalized ratio (INR) =\\\u003C 1.5 institutional ULN (except for patients receiving anticoagulation therapy)\n* Creatinine clearance (CLcr) \\> 60 mL\u002Fmin\n\n  * For this calculation, use the Cockroft-Gault formula\n* Fasting glucose =\\\u003C 150 mg\u002FdL (8.3 mmol\u002FL) and (when indicated) glycosylated hemoglobin (HbA1c ) =\\\u003C 7.5% (58 mmol\u002Fmol)\n* Human immunodeficiency virus (HIV)-infected patients are eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months\n* Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative hepatitis B virus surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV deoxyribonucleic acid \\[DNA\\] test) are eligible. Patients with chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy, if indicated. Patients undergoing current treatment with anti-viral therapy for HBV are ineligible\n* Patients with a history of hepatitis C virus (HCV) infection are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The effects of ipatasertib on the developing human fetus are unknown. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 28 days after the last dose of ipatasertib and agreement to refrain from donating eggs during this same period. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 28 days after the last dose of ipatasertib\n* Ability to understand and the willingness to sign a written informed consent document\n* For the expansion cohort only, patients must agree to undergo mandatory on-treatment biopsies, and have tumors amenable to on-treatment biopsies. This is not applicable to the dose escalation cohort where no on-treatment biopsies are obtained\n\nExclusion Criteria:\n\n* Primary tumor of nasopharynx, salivary, thyroid or parathyroid glands, or skin\n* Distant metastases from the current HNSCC\n* Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted. Biopsies, including those performed under anesthesia, are not considered surgery. Patients who underwent prior definitive surgery alone for an early stage (T1-2N0) HNSCC which has now recurred with stage III-IVB disease at least 3 months after the initial surgery are eligible\n* For patients with a prior history of another malignancy, no prior chemotherapy or radiation may have been administered within 6 weeks prior to study entry. Among patients who received prior radiation to the head and neck or adjacent anatomical site for another malignancy, there may be no overlap with current area to be irradiated\n* Current use of any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib or other agents used in study\n* Treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with uncontrolled intercurrent illness, including active infection\n* Pregnant women are excluded from this study because ipatasertib is an oral AKT inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ipatasertib, breastfeeding should be discontinued if the mother is treated with ipatasertib. These potential risks may also apply to other agents used in this study\n* Patients with type I or type II diabetes mellitus requiring insulin at study entry. Patients with non-insulin dependent type II diabetes mellitus are eligible, as are patients who are on a stable dose of oral diabetes medication \\>= 4 weeks prior to initiation of study treatment. Patients with a history of diabetes mellitus, an abnormal fasting glucose level, or other signs or symptoms indicating diabetes mellitus, must meet the laboratory eligibility criteria for fasting blood glucose and hemoglobin A1c\n* History of or active inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)\n* History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills\n* Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)\n* Known clinically significant history of liver disease consistent with Child Pugh Class B or C, including active viral or other hepatitis (e.g., positive for hepatitis B surface antigen \\[HBsAg\\] or hepatitis C virus \\[HCV\\] antibody at screening), or cirrhosis\n* Grade \\>= 2 uncontrolled or untreated hypercholesterolemia (cholesterol \\> 300 mg\u002FdL or \\> 7.75 mmol\u002FL) or hypertriglyceridemia (triglycerides \\> 300 mg\u002FdL or \\> 3.42 mmol\u002FL)","ALL","18 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I\u002FIb trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy (\"chemo-radiation\") in patients with head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin, which is a chemotherapy used in this trial, is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced 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],"Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Carcinoma of Unknown Primary","Locally Advanced Head and Neck Squamous Cell Carcinoma","Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","Locally Advanced Laryngeal Squamous Cell Carcinoma","Locally Advanced Nasal Cavity Squamous Cell Carcinoma","Locally Advanced Oral Cavity Squamous Cell Carcinoma","Locally Advanced Oropharyngeal Squamous Cell Carcinoma","Locally Advanced Paranasal Sinus Squamous Cell Carcinoma","Locally Advanced Sinonasal Squamous Cell Carcinoma","Maxillary Sinus Squamous Cell Carcinoma","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 III Sinonasal Cancer 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 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Sinonasal Cancer 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","Stage IVB Sinonasal Cancer AJCC v8","RECRUITING","2026-05-15",{"date":55,"type":56},"2026-05-18","ACTUAL",{"date":58,"type":56},"2022-09-19",{"date":60,"type":20},"2027-07-01",{"name":62,"class":63},"National Cancer Institute (NCI)","NIH",18,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"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":73,"type":20},118,[75],"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.",[78,79,27,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109],"Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Cutaneous Squamous Cell Carcinoma of the Head and Neck","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","2026-04-20",{"date":112,"type":56},"2026-04-23",{"date":114,"type":56},"2025-03-12",{"date":116,"type":20},"2029-10-31",{"name":118,"class":119},"Emory University","OTHER",1,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":120},"100420405","phase-1-combining-immunotherapy-salvage-surgery--iort-tx-persistentrecurrent-head--neck-cancer-100420405","NCT04754321","Combining Immunotherapy Salvage Surgery & IORT Tx Persistent\u002FRecurrent Head & Neck Cancer","HNSALV Trial: Combining Immunotherapy With Salvage Surgery and IORT for Treatment of Persistent\u002FRecurrent Head and Neck Cancers","Inclusion Criteria:\n\n* Pathologically confirmed either persistent and\u002F or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H\\&N) squamous cell carcinoma\n* Resectable disease as determined by the surgeon and team\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C 2\n* At least 18 years of age\n* Adequate hematologic, renal, and hepatic function\n* Must have at least 2 week washout period from prior therapy\n* Willingness and ability to provide informed consent\n* Negative pregnancy test for females of reproductive potential\n* Patients who have undergone therapy for their cancer, such as surgery and\u002For chemotherapy and\u002For radiotherapy and recurred\n* Disease measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.\n* Prior definitive and palliative chemotherapy will be allowed\n* Prior radiation therapy will be allowed\n* Tumor tissue from resected site of disease must be provided for biomarker analyses, in addition to urine and blood sample as scheduled per protocol\n* White blood cell (WBC) \\>= 2000\u002FuL (obtained within 14 days of randomization)\n* Neutrophils \\>= 1500\u002FuL (obtained within 14 days of randomization)\n* Platelets \\>= 100 x10\\^3\u002FuL (obtained within 14 days of randomization)\n* Hemoglobin \\> 9.0 g\u002FdL (obtained within 14 days of randomization)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) \\>= 40 mL\u002Fmin (Cockcroft and Gault or Wright formula may be used according to local practice) (obtained within 14 days of randomization)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN\n* Total Bilirubin =\\\u003C 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n* Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for four months after the last dose of pembrolizumab.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\])\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of four months after the last dose of investigational product\n\nExclusion Criteria:\n\n* Requirement of immunosuppressive therapy within 14 days of randomization\n* Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin\n* Prior use of immune checkpoint blockade agent\n* History of human immunodeficiency virus (HIV), hepatitis B, C: Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection, those who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)\n* Unresectable disease, as determined by the surgeon and team\n* Subjects with history of grade 3 toxicity with prior immunotherapy\n* Patients with distant metastases\n* Subjects with active autoimmune disease\n* Breastfeeding women\n* Additional prior malignancy within the previous 3 years (treated or untreated, except for skin carcinomas treated with excision alone and carcinoma in situ of the cervix)\n* Palliative radiotherapy less than 14 days prior to first dose of study drug\n* Any history of hypersensitivity to any of the trial medications\n* Poorly controlled or serious medical or psychiatric illness likely to interfere with participation and\u002For compliance in this clinical trial\n* Prisoners or subjects who are involuntarily incarcerated\n* Patients not available for follow-up\u002Ffuture contact as defined in the ICF\n* Note: Patients on this protocol are not excluded from participation in other clinical trials",{"count":129,"type":20},45,[23],"This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). 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. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.",[27,133,98,100,134,135],"Locally Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Pharyngeal Squamous Cell Carcinoma","Resectable Head and Neck Squamous Cell Carcinoma","2026-01-29",{"date":138,"type":56},"2026-02-02",{"date":140,"type":56},"2022-05-12",{"date":142,"type":20},"2026-12-31",{"name":144,"class":119},"Ohio State University Comprehensive Cancer Center"]