[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-head-and-neck-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-head-and-neck-squamous-cell-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,70,101,122,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100600222","phase-2-ivonescimab-before-surgery-for-the-treatment-of-resectable-stage-ii-iv-head-and-neck-cancer-100600222",false,"NCT07094685","Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer","A Phase II Study Evaluating Neoadjuvant Ivonescimab for Resectable Head and Neck Cancer","SENIOR-HN","Inclusion Criteria:\n\n* At least 18 years of age\n* PD-L1 combined positive score (CPS) \\>= 1\n* Histologically documented advanced stage mucosal HNSCC (stage II-IV), for which surgery would be recommended in routine clinical practice\n* Primary tumor is amenable to fresh biopsy or availability of archival fresh frozen primary tissue\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n* Absolute neutrophil count \\> 1500 cells\u002FuL\n* Platelet count \\>= 100,000\u002FuL\n* Hemoglobin \\>= 9.0 g\u002FdL (without transfusion within 14 days prior to cycle 1, day 1)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) or =\\\u003C 3 x ULN for participants with Gilbert's disease\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x institutional ULN\n* Creatinine =\\\u003C 1.5 x institutional ULN OR estimated glomerular filtration rate (eGFR) value \\>= 30\u002FmL using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation OR measured (OR calculated) creatinine clearance \\>= 50 mL\u002Fmin using the Cockcroft-Gault Formula\n* Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n* Prothrombin time (PT) or international normalized ratio (INR) =\\\u003C 1.5 x ULN, and partial thromboplastin time (PTT) or activated (a)PTT =\\\u003C 1.5 x ULN (unless abnormalities are unrelated to coagulopathy) This applies only to patients who are not on therapeutic anti-coagulation\n\n  * For patients receiving therapeutic anti-coagulation there are no coagulation parameters for eligibility. However, patients should be on a stable dose\n* Female patients of childbearing age per institutional definition must have negative serum pregnancy test results before enrollment\n* Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of ivonescimab\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab\n* Ability to understand and the willingness to sign a written informed consent\n* Deemed to be a candidate for trial therapy by University of Michigan providers in both Medical Oncology and Otolaryngology or Oral and Maxillofacial Surgery\n\nExclusion Criteria:\n\n* Prior radiation therapy for treatment of the current mucosal HNSCC (patients undergoing salvage resection are excluded)\n* Prior neck dissection on the side of current mucosal HNSCC\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment. Minor local procedures (excluding central venous catheterization, port implantation, and tumor biopsy) within 3 days prior to planned cycle 1, day 1\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment\n* Nasal bleeding \u002F epistaxis (bloody nasal discharge is allowed) graded as \\>= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 within 14 days prior to registration\n* Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as INR or aPTT is within therapeutic limits\n* Patients with a condition requiring corticosteroid therapy (\\> 10 mg prednisone\u002Fday or equivalent) within 14 days of the first dose of study drug. Exceptions: Physiologic replacement doses are allowed even if they are \\> 10 mg of prednisone\u002Fday or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder\n* Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. Exceptions: Patients with vitiligo, type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that has resolved, or psoriasis that does not require systemic treatment are permitted\n* Patients with symptomatic central nervous system (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis \\>= 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease\n* Recipient of a solid organ or allogeneic stem cell transplant\n* Patients with active hepatitis B (Patients with stable or declining levels of hepatitis B deoxyribonucleic acid \\[DNA\\] by polymerase chain reaction \\[PCR\\] on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment will not be excluded)\n* Patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV ribonucleic acid \\[RNA\\] levels above the lower limit of detection)\n* Known allergy or hypersensitivity to any component of the study drug or any excipients (histidine, histidine hydrochloride, sucrose, polysorbate 80 (II), and water for injection); known history of severe hypersensitivity to other monoclonal antibodies\n* Patient is breastfeeding or plans to breastfeed during study participation\n* Radiographic evidence of major blood vessel encasement with narrowing of the vessel that the investigator determines will pose a significantly increased risk of bleeding\n* Live vaccine or live attenuated vaccine received within 4 weeks prior to planned enrollment or scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n* Has pre-existing peripheral neuropathy that is \\>= grade 2 by CTCAE version 5\n* History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Participant has active cardiovascular disease including, but not limited to:\n\n  * Thromboembolism\n\n    * Medical history of any grade arterial thromboembolic event, grade 3 and above venous thromboembolic event (as specified in NCI CTCAE 5.0)\n  * Cardiovascular disease\n\n    * Any of the following within 12 months prior to enrollment:\n\n      * Myocardial infarction\n      * Unstable angina\n      * Unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease)\n      * Transient ischemic attack\n      * Cerebrovascular accident\n      * Hypertensive Crisis\n      * Hypertensive encephalopathy\n      * Coronary stent placement\n    * Clinically non-significant thrombosis, such as non-obstructive catheter-associated thrombus, incidental or asymptomatic pulmonary embolism, are not exclusionary\n  * Hypertension\n\n    * Uncontrolled (persistent) hypertension:\n\n      * Systolic blood pressure \\> 160 mmHg; diastolic blood pressure \\> 100 mmHg\n  * Heart failure\n\n    * Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF within 12 months prior\n* Participant has uncontrolled illness including, but not limited to:\n\n  * Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B or C)\n  * Uncontrolled diabetes\n  * Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy)\n  * Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements\n  * Active bleeding diathesis requiring anticoagulant or antiplatelet therapy","ALL","18 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispecific monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).",[27,28,29,30,31],"Advanced Head and Neck Squamous Cell Carcinoma","Resectable Head and Neck Squamous Cell Carcinoma","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-26","ACTUAL",{"date":38,"type":36},"2025-11-18",{"date":40,"type":21},"2030-11-01",{"name":42,"class":43},"University of Michigan Rogel Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100495068","phase-2-preoperative-pembrolizumab-and-chemotherapy-in-resectable-recurrent-hnscc-100495068","NCT05726370","Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC","A Phase 2 Study of Preoperative Pembrolizumab and Chemotherapy Followed by Adjuvant Pembrolizumab in Resectable Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC in a previously irradiated field, defined as \\>50% of the presurgical tumor volume having prior radiation dose of \\>45 Gy as determined by the treating radiation oncologist (including primary sites, such as oral cavity, oropharynx, larynx or hypopharynx carcinoma).\n* Participants must be a candidate for curative intent surgery.\n* Participants must have documented time of ≥ 6 months from completion of prior curative intent treatment for HNSCC (surgery and\u002For radiation therapy with\u002Fwithout platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence or a second primary in a previously irradiated field.\n* Participants must be willing to undergo a mandatory pre-treatment biopsy and willing to provide blood and tissue from the pre-treatment biopsy and at the time of surgery. Exceptions may be made after discussion with sponsor if it is not medically feasible to obtain a pre-treatment biopsy or is in the best interest of the patient. Archival tissue may be collected in this situation. Participants will be offered the opportunity to volunteer for optional biopsies at the time of recurrence of disease.\n* Participants may have any smoking history (no restrictions)\n* Participants may have any Human Papilloma Virus (HPV) status of the tumor. Patients with oropharyngeal cancer are required to undergo HPV testing with p16 immunohistochemistry and\u002For confirmatory HPV PCR or ISH testing\n* Age ≥18 years\n* ECOG performance status 0 or 1 (Karnofsky ≥70%, see Appendix A)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Because pembrolizumab and chemotherapy can be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  * a. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR\n  * b. A WOCBP who agrees to follow the contraceptive guidance in Appendix B during the treatment period and for at least 180 days after the last dose of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Sinonasal, nasopharyngeal or cutaneous primary site of squamous cell carcinoma of the head and neck\n* Has known distant metastatic disease. Those with known brain metastases should be excluded from this clinical trial, because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic\n* Has had chemotherapy or radiotherapy for HNSCC in curative intent setting within 6 months prior to entering the study.\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 (eg, CTLA-4, OX 40, CD137).\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\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 known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has a history of allergic reactions to agents used in study\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\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 participant's participation for the full duration of the study, or is not in the best interest of the participant 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* Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia\n* Has had an allogeneic tissue\u002Fsolid organ transplant\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to study registration (see Appendix B). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because pembrolizumab and chemotherapy agents have 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 and chemotherapy, breastfeeding should be discontinued if the mother is treated on this protocol.",{"count":20,"type":21},[24],"This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery.\n\nThe names of the study drugs involved in this research study are:\n\n* pembrolizumab (a type of immunotherapy)\n* docetaxel (a type of chemotherapy)\n* cisplatin (a type of chemotherapy)\n* carboplatin (a type of chemotherapy)",[56,57,28,58,59],"Head and Neck Squamous Cell Carcinoma","Head and Neck Cancer","Recurrent Head and Neck Squamous Cell Carcinoma","Second Primary Squamous Cell Carcinoma of the Head and Neck",[56,57,28,58,59],"2026-06-21",{"date":33,"type":36},{"date":64,"type":36},"2023-05-20",{"date":66,"type":21},"2030-05-20",{"name":68,"class":43},"Dana-Farber Cancer Institute",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100639751","phase-2-effects-of-infusion-timing-on-treatment-response-in-solid-tumors-100639751","NCT07630168","Effects of Infusion Timing on Treatment Response in Solid Tumors","Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors","TIMED","Inclusion Criteria:\n\nCohort 1A and 1B:\n\n* Participants with metastatic non-small cell lung cancer (NSCLC).\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nCohort 2A and 2B:\n\n* Participants with resectable head and neck squamous cell carcinoma (HNSCC)\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement\n* of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nExclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)\n\n* Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.\n* Prior ICI (PD-1\u002FPD-L1\u002FCTLA4) treatment received less than 6 months from the time of screening.\n* Subject is participating in another treatment clinical trial.",{"count":79,"type":21},238,[24],"This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.",[83,84,85,57,86,87,88],"Lung Cancer","Non-small Cell Lung Cancer","Metastatic Lung Cancer","Metastatic Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Resectable Head and Neck Squamous-cell Carcinoma",[90,91],"programmed cell death protein 1","programmed death-ligand 1","NOT_YET_RECRUITING","2026-06-01",{"date":95,"type":36},"2026-06-05",{"date":93,"type":21},{"date":98,"type":21},"2033-01-01",{"name":100,"class":43},"UNC Lineberger Comprehensive Cancer Center",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":44},"100630841","phase-2-neoadjuvant-sacituzumab-govitecan-plus-tagitanlimab-for-resectable-head-and-neck-squamous-cell-carcinoma-100630841","NCT07492914","Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma","A Single-Arm, Phase II Prospective Study Of Lucanoximab Combined With Tagolimab As Neoadjuvant Therapy For Resectable Head And Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Aged 18 years and above, of any gender.\n* Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹\u002FL, platelet count (PLT) ≥80×10⁹\u002FL, hemoglobin ≥8 g\u002FdL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) \\>60 mL\u002Fmin; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.\n* Voluntarily participate in the study, sign the informed consent form, and be able to comply with scheduled study visits and relevant procedures in the protocol.\n\nExclusion Criteria:\n\n* A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ).\n* Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome.\n* A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs.\n* Prior anti-tumor treatment involving anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy.\n* Receipt of a live infectious vaccine within 4 weeks prior to the first dose or planned vaccination during the study period; major surgery or severe trauma within 4 weeks prior to the first dose.\n* Systemic use of corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressants within 14 days prior to the first dose (inhaled or topical steroids and adrenal replacement therapy are permitted).\n* Severe medical conditions, including New York Heart Association (NYHA) class II or higher heart failure, ischemic heart disease, clinically significant arrhythmias requiring intervention, left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography, or prolonged QTc interval (males \\>450 msec, females \\>470 msec).\n* A known history of interstitial lung disease or high clinical suspicion of interstitial lung disease; active pulmonary tuberculosis or uncontrolled previous tuberculosis infection.\n* Hyperthyroidism or organic thyroid disease (patients with hypothyroidism under stable thyroid hormone replacement therapy are eligible for enrollment).\n* Active infection, unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within 1 week prior to signing the informed consent form.\n* Active hepatitis B (HBV DNA ≥2000 IU\u002Fml or ≥10⁴ copies\u002Fml), active hepatitis C (positive anti-HCV and HCV RNA above the lower limit of detection), positive HIV antibody, or a history of acquired immunodeficiency syndrome (AIDS).\n* A definite history of neurological or psychiatric diseases such as epilepsy or dementia.\n* A history of drug or alcohol abuse.\n* Pregnant or lactating females; patients (or their partners) planning pregnancy, having unprotected sexual intercourse, or refusing to take effective contraceptive measures during the study and for 3 months after study completion.\n* Receipt of other investigational drugs within 4 weeks prior to the first dose, or concurrent participation in other interventional clinical studies (observational or follow-up interventional studies are excluded).\n* Other circumstances deemed unsuitable for study participation by the investigator.",{"count":109,"type":21},30,[24],"The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are:\n\nDoes the combination of Sacituzumab govitecan and Tagitanlimab improve the major pathological response rate (MPR) in patients with resectable HNSCC?\n\nWhat adverse reactions (side effects) do participants experience when receiving this combined neoadjuvant therapy?\n\nDoes this combined therapy improve participants' objective response rate (ORR), survival time and quality of life?\n\nThis is a single-arm, open-label, prospective Phase II clinical study conducted at West China Hospital of Sichuan University. A total of 30 eligible patients will be enrolled, and no placebo control will be used. The study will evaluate the efficacy and safety of the combined therapy by monitoring clinical indicators, pathological results and adverse events throughout the trial.\n\nParticipants will:\n\nReceive Sacituzumab govitecan (5mg\u002Fkg) and Tagitanlimab (900mg) intravenously every 2 weeks, for a total of 2 treatment cycles.\n\nPatients will undergo surgical resection 3-6 weeks after completion of neoadjuvant therapy. Adjuvant therapy (concurrent chemoradiotherapy or radiotherapy alone) will be administered according to pathological risk factors, together with 15 cycles of Tagitanlimab as adjuvant immunotherapy.\n\nVisit the clinic regularly for physical examinations, laboratory tests (such as blood routine, liver and kidney function), imaging examinations (such as head and neck MRI\u002FCT) and safety checkups according to the study schedule.\n\nProvide biological samples (peripheral blood, tumor tissue, saliva, feces) at specified time points for biomarker detection.\n\nComplete quality-of-life questionnaires (such as EORTC QLQ-C30) regularly to assess changes in daily functioning.\n\nNote: Participants will not be charged for the study drugs (Sacituzumab govitecan and Tagitanlimab ), and will receive appropriate subsidies for study-related visits and blood collection. The research team will provide active treatment and corresponding compensation if participants experience study-related adverse reactions.",[28],"2026-05-10",{"date":115,"type":36},"2026-05-13",{"date":117,"type":21},"2026-05-11",{"date":119,"type":21},"2031-03-31",{"name":121,"class":43},"West China Hospital",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":44},"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":130,"type":21},45,[132],"PHASE1","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.",[135,136,137,138,139,28],"Head and Neck Carcinoma of Unknown Primary","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Pharyngeal Squamous Cell Carcinoma","2026-01-29",{"date":142,"type":36},"2026-02-02",{"date":144,"type":36},"2022-05-12",{"date":146,"type":21},"2026-12-31",{"name":148,"class":43},"Ohio State University Comprehensive Cancer Center",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":170,"locationsCount":44},"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":157,"type":21},24,[132],"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.",[161,28,162,163,88],"Human Papillomavirus-Negative Neck Squamous Cell Carcinoma","Resectable Human Papillomavirus-Independent Head and Neck Mucosal Squamous Cell Carcinoma","HPV-Negative Squamous Cell Carcinoma","2026-01-23",{"date":166,"type":36},"2026-01-26",{"date":164,"type":36},{"date":169,"type":21},"2027-11-08",{"name":171,"class":43},"Mayo Clinic"]