[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hpv-negative-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hpv-negative-squamous-cell-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,79,104],{"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":25,"conditions":26,"keywords":29,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100635428","phase-1-ficerafusp-alfa-pembrolizumab-and-stereotactic-body-radiotherapy-sbrt-for-head-and-neck-squamous-cell-carcinoma-hnscc-100635428",false,"NCT07552558","Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)","Phase I\u002FII Trial of Neoadjuvant Combination of Ficerafusp Alfa, Pembrolizumab, and SBRT for Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically confirmed locally advanced, OPC HPV-negative head and neck squamous cell carcinoma (OPSCC) or HNSCC arising from oral cavity, larynx, or hypopharynx.\n* Baseline resectable disease per the judgment of the treating surgical oncologist.\n* Clinical stage III, IVA, or IVB disease as defined using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T1-2, N1-3 or\n  * T3, any N or\n  * T4, any N\n* Documented tumor PD-L1 CPS ≥ 1 (by PD-L1 IHC pharmDx assay), determined locally.\n* Willing to provide blood and newly obtained core or excisional biopsy of tumor lesion pre-treatment and at the time of surgery for pathologic and correlative analyses.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9 g\u002FdL (without PRBC transfusion in the prior 7 days)\n  * Total serum bilirubin ≤ 1.5 x IULN (except for subjects with documented diagnosis of Gilbert syndrome). For subjects with a documented diagnosis of Gilbert's syndrome, total bilirubin must be ≤ 3.0 × ULN, provided that direct bilirubin is within normal limits\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN\n  * Creatinine clearance (measured or calculated via the Cockcroft-Gault equation or per institutional standards) ≥ 30 mL\u002Fmin\n  * PT\u002FINR or aPTT ≤ 1.5 x IULN (except for subjects receiving anticoagulant therapy)\n* The effects of pembrolizumab and ficerafusp alfa on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days (women) or 90 days (men) after completion of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Currently receiving any other investigational agents.\n* Prior history of grade ≥ 2 intolerance or hypersensitivity reactions to other murine proteins, or the active substances of ficerafusp alfa, pembrolizumab, or any of their excipients.\n* At higher risk of bleeding, including known bleeding diathesis or current active major bleeding, or recent major bleeding episode (within 4 weeks prior to enrollment).\n* Any of the following within 6 months prior to starting study treatment: ST-elevation myocardial infarction, severe\u002Funstable angina, uncontrolled cardiac ventricular arrhythmia, coronary\u002Fperipheral artery bypass graft or stent, cerebrovascular accident\u002Fstroke less than 6 months prior to enrollment, or congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically stable can enroll if they are on a stable dose of anticoagulants for at least 3 months.\n* Active autoimmune disease requiring 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.\n* Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.\n* Chronic hepatitis B virus (HBV) infection with active disease meeting the criteria for anti-HBV therapy but not on a suppressive antiviral therapy prior to initiation of study treatment. HBV testing not required in the absence of known history of infection. Note: Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. These subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.\n* Known history of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible provided they completed curative antiviral therapy at least 4 weeks prior to initiation of study treatment. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies) with viral load \\>0 or CD4\\\u003C350. HIV testing is not required in the absence of known history of infection.\n* Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.\n* Known to be diagnosed and\u002For treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific antigen \\\u003C 10 ng\u002FmL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study entry. Other exceptions may be considered with the PI's consultation. The time requirement for no malignancy for 2 years does not apply to the cancer for which a subject is enrolled in the study.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the principle-Investigator.\n* Use of a live or live attenuated vaccine within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.\n* Pregnant or breastfeeding. People of childbearing potential must have a negative pregnancy test at screening and within 7 days of first dose of study treatment.","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The study is an open-label phase I\u002FII clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.",[27,28],"Head and Neck Squamous Cell Carcinoma","HPV-Negative Squamous Cell Carcinoma",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65],"Shortened fractionation radiation","Immunotherapy","Curative treatment","Oral cavity cancer","Tongue cancer","Gum cancer","Jaw cancer","Palate cancer","Lip Cancer","Throat cancer","Mouth cancer","Voice box cancer","Head and neck cancer","Oral cancer","Laryngeal cancer","Mandibular cancer","Alveolar ridge cancer","Hypopharyngeal cancer","Oropharyngeal cancer","OPSCC","OCC","OCSCC","HNSCC","Squamous cell carcinoma","Neoadjuvant therapy","Preoperative treatment","Stereotactic body radiotherapy","Radiation therapy","Targeted therapy","Keytruda","BCA101","PD-1 inhibitor","EGFR inhibitor","Checkpoint inhibitor","Locally advance","HP-negative","NOT_YET_RECRUITING","2026-05-29",{"date":69,"type":70},"2026-06-03","ACTUAL",{"date":72,"type":20},"2026-06-30",{"date":74,"type":20},"2033-08-31",{"name":76,"class":77},"Washington University School of Medicine","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":78},"100592720","phase-1-decitabine-in-combination-with-standard-of-care-therapy-for-the-treatment-of-surgically-resectable-hpv-negative-head-and-neck-cancer-100592720","NCT06997094","Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer","Phase I Decitabine Dose-Tolerance in Surgically Resectable HPV-Negative Head and Neck Cancer","Inclusion Criteria:\n\n* REGISTRATION: Age ≥ 18 years\n* REGISTRATION: Histologic confirmation of HPV-negative, squamous cell carcinoma of the head and neck that is surgically resectable. HPV-status confirmation by p16, circulating tumor DNA or in-situ hybridization is only required for oropharyngeal primaries\n\n  * Includes mucosal and non-mucosal subsites\n  * Includes head and neck of unknown primary origin REGISTRATION: Measurable disease preoperatively, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or equivalent criteria\n  * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible\n* REGISTRATION: Absence of distant metastases on standard diagnostic work-up ≤ 16 weeks prior to registration. (chest computed tomography \\[CT\\] or positron emission tomography \\[PET\\]\u002FCT)\n* REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* REGISTRATION: Hemoglobin ≤ 9.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research\n* REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Patient received pre-operative decitabine dose\n* RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: The patient had study-specific surgery\n* RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Patient meets adjuvant radiation criteria based on investigator choice\n\nExclusion Criteria:\n\n* REGISTRATION: Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women who are of childbearing potential who are unwilling to employ adequate contraception\n* REGISTRATION: 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\n* REGISTRATION: 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* REGISTRATION: Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment\n\n  * EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment\n* REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n* REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* REGISTRATION: Other active malignancy ≤ 5 years prior to registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* REGISTRATION: History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* REGISTRATION: Prior history of radiation therapy to the affected site\n* REGISTRATION: Prior systemic chemotherapy ≤ 5 years prior to registration for other diagnosis not related to study disease\n* REGISTRATION: Contraindication to radiation therapy as determined by the treating team\n* REGISTRATION: Contraindication to decitabine as determined by the treating team\n* RE-REGISTRATION FOR ADJUVANT DOSE ASSIGNMENT: Experienced a dose limiting toxicity (DLT) during pre-operative decitabine therapy",{"count":87,"type":20},24,[23],"This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and\u002For chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower progression and longer survival. Decitabine is also a clinically active demethylating agent, and may help make tumor cells more sensitive to radiation therapy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. External beam radiation therapy (EBRT) is a type of radiation that uses a machine to aim high-energy rays at the tumor from outside the body. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving decitabine in combination with standard of care surgery, radiation and\u002For chemotherapy may be safe, tolerable, and\u002For effective in treating patients with surgically resectable HPV-negative head and neck squamous cell cancers.",[91,92,93,28,94],"Human Papillomavirus-Negative Neck Squamous Cell Carcinoma","Resectable Head and Neck Squamous Cell Carcinoma","Resectable Human Papillomavirus-Independent Head and Neck Mucosal Squamous Cell Carcinoma","Resectable Head and Neck Squamous-cell Carcinoma","RECRUITING","2026-01-23",{"date":98,"type":70},"2026-01-26",{"date":96,"type":70},{"date":101,"type":20},"2027-11-08",{"name":103,"class":77},"Mayo Clinic",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":78},"100516500","phase-1-personalized-adaptive-treatment-for-locally-advanced-head-and-neck-cancer-100516500","NCT06005324","Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer","Pilot Study of Induction Therapy Followed by Response-adaptive Treatment and Dynamic Changes in Circulating Tumor DNA in Locoregionally Advanced HPV Negative Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patients must have pathologically confirmed locally advanced, non-metastatic, human papillomavirus (HPV) negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.\n* Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th edition.\n* If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.\n* Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.\n* Patients must be at least 18 years of age.\n* Measurable disease (either primary site and\u002For nodal disease) by RECIST 1.1 criteria.\n* No previous radiation or chemotherapy for a head and neck cancer.\n* No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy\u002Fexcision of the tumor with residual measurable disease is acceptable.) No surgical procedures or core-needle or excisional biopsies will occur after baseline scans are performed and measurable lesions are identified. Fine-needle aspiration can be performed (i.e., to confirm extent of baseline lymph node involvement) following discussion with PI if not performed on a target lesion.\n* Performance status 0-1\n* Normal Organ Function\n\n  * Leukocytes ≥ 3000\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Absolute neutrophil count ≥ 1,500\n  * Hemoglobin ≥ 9.0 gm\u002FdL\n  * Aspartate Aminotransferase (AST) ≤ 2.5x upper limit of normal\n  * Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal\n  * Alkaline phosphatase ≤ 2.5x upper limit of normal\n  * Albumin \\> 2.9 gm\u002FdL\n  * Total bilirubin ≤ 1.5 mg\u002FdL\n  * Creatinine clearance (CrCl) \\> 45 mL\u002Fmin, normal within 2 weeks prior to start of treatment (Of note, the standard Cockcroft and Gault formula must be used to calculate CrCl for enrollment or dosing)\n* Patients must sign a study-specific informed consent form prior to study entry. Patients 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 with study drug(s) plus 5 months after completing chemoradiation or receiving the last dose of chemoradiation, whichever occurs latest.\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) plus 5 months after completing chemoradiation or receiving the last dose of chemoradiation, whichever occurs latest.\n\nExclusion Criteria:\n\n* Unequivocal demonstration of distant metastatic disease (M1 disease).\n* Unidentifiable primary site.\n* Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance. Patients with clinically stable and\u002For chronically managed medical illnesses that are not symptomatic and\u002For are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).\n* Prior surgical therapy other than incisional\u002Fexcisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.\n* Patients receiving other investigational agents.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Known history of active tuberculosis (Bacillus Tuberculosis infection).\n* Hypersensitivity to cetuximab or any other drug used in this protocol.\n* Prior systemic anti-cancer treatment within the last 8 weeks.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment.\n* Has a history of HIV.\n* Has known active Hepatitis B or Hepatitis C. If eradicated, patient is eligible.\n* Has received a live vaccine within 28 days of planned start of study therapy.",{"count":112,"type":20},36,[23],"This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer.",[28],"2025-06-06",{"date":118,"type":70},"2025-06-08",{"date":120,"type":70},"2023-12-18",{"date":122,"type":20},"2026-12",{"name":124,"class":77},"University of Chicago"]