[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"throat-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:throat-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,77],{"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":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100471597","phase-2-a-study-of-pembrolizumab-in-combination-with-chemotherapy-for-head-and-neck-cancer-100471597",false,"NCT05420948","A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer","A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)","Inclusion Criteria:\n\n* Have clinically confirmed head and neck cancer that is recurrent (comes back\u002Freturns to the body) or metastatic (spreads to other parts of the body).\n* Participants should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 3 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.\n* Greater than or equal to 18 years old.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have measurable disease based on RECIST 1.1 as determined by the site. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participants must have normal organ and marrow function as defined by clinical lab values.\n* Participants must have provided tissue for programmed cell death ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate). Repeat samples may be required if adequate tissue is not provided. A newly obtained biopsy (within 90 days prior to start of study treatment) is strongly preferred, but an archival sample is acceptable.\n* Measurable disease (either primary site and\u002For nodal disease) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Participants must sign a study-specific informed consent form prior to study entry. Participants should have the ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug.\n* Women must not be breastfeeding.\n* Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.\n* Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).\n\nExclusion Criteria:\n\n* Has disease that is suitable for local therapy administered with curative intent.\n* Has progressive disease (PD) within three (3) months of completion of curatively intended systemic treatment for locoregionally advanced head and neck cancer.\n* Participants who are receiving any other investigational agents.\n* Participants in whom signatera ctDNA is not measurable at baseline.\n* Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment or patient has not fully recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered treatment.\n\n  * Note: Participants with ≤Grade 2 neuropathy, ≤Grade 2 alopecia, are an exception to this criterion and may qualify for the study.\n  * Note: If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Active, known, or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low-dose prednisone (\\\u003C= 10mg or equivalent). The following are exceptions to these criteria:\n* Participants with vitiligo or alopecia.\n* Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n* Any chronic skin condition that does not require systemic treatment.\n* Has a life expectancy of less than 3 months and\u002For has rapidly progressing disease (e.g. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.\n* Participants with a \"currently active\" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for ≥ 3 years.\n* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in study.\n* Has received prior therapy with an anti-PD1(anti-programmed cell death protein1) therapy.\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* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Pregnant women are excluded from this study because pembrolizumab is an agent 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 pembrolizumab, breastfeeding should be discontinued if the mother is treated with pembrolizumab. These potential risks may also apply to other agents used in this study.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pembrolizumab, carboplatin, and paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Has known active Hepatitis B or Hepatitis C. However, if eradicated participant is eligible.\n* Has a history of active infection requiring systemic therapy.\n* Has received a live vaccine within 28 days of planned start of study therapy. Note: Vaccines for COVID-19 are allowed except for any live vaccine that may be developed.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.",[26,27,28,29,30],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Neoplasms","Head Cancer","Throat Carcinoma",[32],"head and neck cancer","RECRUITING","2026-05-08",{"date":36,"type":37},"2026-05-12","ACTUAL",{"date":39,"type":37},"2022-10-17",{"date":41,"type":20},"2026-12-01",{"name":43,"class":44},"University of Chicago","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100362734","phase-2-web-based-program-in-helping-patients-with-head-and-neck-cancer-adhere-to-swallowing-exercises-and-coping-strategies-100362734","NCT04003051","Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies","Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings","Inclusion Criteria:\n\n* Receiving radiation treatment with curative intent for throat cancer\n* Can read and speak English or Spanish well enough to answer our questionnaires and understand our website content.",{"count":54,"type":20},300,[23],"This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.",[30],[59,60,61,62,63,64,65,66],"Head and neck cancer","swallowing","trismus","adherence","coping","rural","website","access","2026-04-10",{"date":69,"type":37},"2026-04-15",{"date":71,"type":37},"2019-03-18",{"date":73,"type":20},"2026-12-31",{"name":75,"class":44},"M.D. Anderson Cancer Center",2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":45},"100396650","phase-2-testing-less-intensive-radiation-with-chemotherapy-to-treat-low-risk-patients-with-hpv-positive-oropharyngeal-cancer-100396650","NCT04444869","Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer","Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx \"ENID\"","ENID","Inclusion Criteria:\n\n* Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.\n* Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).\n* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.\n* Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.\n* Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:\n\n  * General history and physical examination within 30 days prior to registration;\n  * Fiberoptic exam with laryngopharyngoscopy (mirror and\u002For fiberoptic and\u002For direct procedure) within 60 days prior to registration;\n  * One of the following combinations of imaging is required within 45 days prior to registration:\n\n    1. A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast);\n    2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);\n    3. or a CT scan of neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast);\n    4. or an MRI of the neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast).\n\nNote: A CT scan of neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as both staging and planning tools.\n\n* Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.\n\nNumber of pack-years = \\[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\\] \u002F 20 Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined.\n\n* Zubrod Performance Status of 0-1 within 30 days prior to registration;\n* Adequate hematologic function within 14 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3;\n  * Platelets ≥ 100,000 cells\u002Fmm3;\n  * Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.\n* Adequate renal function within 14 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin\n* Adequate hepatic function within 14 days prior to registration defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002Fdl;\n  * AST or ALT \\\u003C 3 x the upper limit of normal.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n\nExclusion Criteria:\n\n* Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;\n* Carcinoma of the neck of unknown primary site origin (even if p16 positive);\n* T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.\n* Radiographically matted nodes, that span 6 cm or more; N3 disease\n* Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;\n* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;\n* 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.\n* Simultaneous primary cancers or separate bilateral primary tumor sites;\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n  * Transmural myocardial infarction within the last 6 months;\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.",{"count":86,"type":20},28,[23],"This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.",[90,91,92,30],"Cancer of the Head and Neck","Oropharynx Cancer","HPV Positive Oropharyngeal Squamous Cell Carcinoma","2024-05-16",{"date":95,"type":37},"2024-05-17",{"date":97,"type":37},"2020-09-28",{"date":99,"type":20},"2026-06",{"name":101,"class":44},"University of Missouri-Columbia"]