[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrentmetastatic-head-and-neck-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrentmetastatic-head-and-neck-squamous-cell-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,65,81,102,128,148],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100597494","phase-1-a-trial-of-shr-a2102-with-adebrelimab-with-or-without-other-anti-tumor-therapies-in-recurrentmetastatichead-and-neck-squamous-cell-carcinoma-cancer-100597494",false,"NCT07059221","A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent\u002FMetastaticHead and Neck Squamous Cell Carcinoma Cancer","A Multicenter, Open-label Phase Ib\u002FII Clinical Trial of SHR-A2102 Injection in Combination With Adebrelimab Injection, With or Without Other Anti-tumor Therapies, in Subjects With Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.\n2. Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.\n3. At least one measurable lesion according to RECIST v1.1 criteria.\n4. The ECOG score is 0 or 1.\n5. Expected survival ≥12 weeks.\n6. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n\\-\n\n1\\. Subjects will not be screened if they meet any of the following conditions:\n\n1. Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin;\n2. Locally advanced patients who are candidates for curative surgery or local therapy and have the intention to undergo such treatment;\n\n2\\. Known hypersensitivity to the investigational drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.\n\n3\\. Prior treatments or medications before the first dose of the study drug:\n\n1. Use of any investigational drug within 4 weeks before the first dose;\n2. Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) study or follow-up in an interventional study; 4. Active autoimmune disease or a history of autoimmune disorders. 5. Residual toxicity from prior anticancer therapy not resolved to ≤Grade 1 (CTCAE v5.0) (except for non-safety risks, such as alopecia) or not meeting the inclusion\u002Fexclusion criteria.\n\n6\\. Uncontrolled or symptomatic active CNS metastases. 7. Symptomatic visceral metastases with imminent life-threatening complications .\n\n8\\. Severe bone damage caused by tumor bone metastasis, including severe bone pain that is poorly controlled; pathological fractures in important areas that occurred within 6 months before the first medication or are expected to occur very soon; and spinal cord compression.\n\n9\\. Known or suspected interstitial lung disease (ILD) or severe pulmonary conditions.\n\n10\\. Other active malignancies within 3 years before study entry. 11. Have a history of immunodeficiency, including a positive HIV test result, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.\n\n12\\. Clinically significant cardiovascular disease. 13. Active or chronic infections of clinical significance. 14. Pregnancy or lactation. 15. Other factors that, in the investigator's judgment, may lead to premature study discontinuation.","ALL","18 Years","75 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102\u002FSHR-9839(sc) with Adebrelimab with or without other Antitumor Therapy in Subjects with Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma.\n\nTo explore the reasonable dosage of SHR-A2102\u002FSHR-9839（sc） for Subjects with Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma",[28],"Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma","RECRUITING","2026-06-28",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":33},"2025-07-11",{"date":37,"type":21},"2029-03",{"name":39,"class":40},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100599724","phase-2-sacituzumab-tirumotecan-and-toripalimab-in-the-first-line-treatment-of-hnscc-100599724","NCT07088211","Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC","Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma Patients With trop2 and CPS Positive: A Prospective, Single Arm, Phase II Trial","Inclusion Criteria:\n\n* Aged 18-75 years, regardless of gender; Histologically or cytologically confirmed newly diagnosed locally advanced, recurrent or metastatic head and neck squamous cell carcinoma (primary tumor sites include oropharynx, oral cavity, hypopharynx, and larynx) that cannot be cured by local treatment. No anti-tumor systemic treatment has been received in the recurrent or metastatic stage (systemic treatment as part of local advanced tumor treatment is allowed, provided that more than 6 months have passed from the end of treatment to the signing of informed consent); ECOG performance status of 0 or 1; Expected survival period ≥ 12 weeks; At least one measurable lesion according to RECIST 1.1 criteria. Lesions that have received previous radiotherapy can be used as measurable lesions if disease progression occurs; Availability of tumor tissue for PD-L1 detection (paraffin-embedded specimens within 2 years or fresh tumor tissue); PD-L1 CPS ≥ 1 and positive trop2 expression, detected by immunohistochemistry; For oropharyngeal cancer patients, P16 detection status, detected by IHC;\n\nNormal function of major organs within 2 weeks before treatment, meeting the following criteria:\n\nBone marrow function: Hemoglobin ≥ 100g\u002FL, white blood cell count ≥ 4.0×10\\^9\u002FL or neutrophil count ≥ 2.0×10\\^9\u002FL, platelet count ≥ 100×10\\^9\u002FL without blood transfusion or colony-stimulating factor support; Liver function: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times the upper limit of normal; Renal function: Serum creatinine level \\\u003C 1.5 times the upper limit of normal or creatinine clearance rate ≥ 60ml\u002Fmin, blood urea nitrogen ≤ 200mg\u002FL; Urinary protein \\\u003C +; if urinary protein is +, the 24-hour total protein must be \\\u003C 500mg; Blood glucose: Within the normal range and\u002For for diabetic patients, blood glucose is controlled in a stable state during treatment; Cardiac function: No myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency; For women of childbearing age, serum pregnancy test results must be negative within 7 days before the first administration of the trial drug; males with reproductive capacity or females with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides) throughout the trial, and continue contraception for 12 months after the end of treatment; Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; Patients whom doctors believe can benefit from the treatment.\n\nExclusion Criteria:\n\n* Disease progression occurring within 6 months after systemic treatment for locally advanced head and neck squamous cell carcinoma; A history of primary nasopharyngeal carcinoma; Central nervous system metastasis and\u002For carcinomatous meningitis; Patients with hearing loss ≥ grade 2 or neuropathy ≥ grade 2 who are currently receiving anti-tumor treatment; Patients who have participated in or are participating in other drug\u002Ftherapy clinical trials within 4 weeks before the first administration of the study drug; Patients who have received hematopoietic stimulating factors (such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc.) within 1 week before the first administration of the study drug; Positive results for HIV antibody or Treponema pallidum antibody tests;\n\nPatients with active hepatitis B or hepatitis C:\n\nFor those with positive HBsAg or HBcAb, additional HBV DNA testing is required (if the result is higher than the upper limit of the normal range); For those with positive HCV antibody test results, additional HCV RNA testing is required (if the result is higher than the upper limit of the normal range); Active lung diseases (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active pulmonary tuberculosis; Patients with any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo that does not require systemic treatment can be included; asthma that has been completely relieved in childhood and requires no intervention in adulthood can be included; asthma in patients requiring medical intervention with bronchodilators cannot be included); Patients who are using immunosuppressants or systemic hormone therapy for the purpose of immunosuppression (dose \\> 10mg\u002Fday prednisone or other hormones with equivalent efficacy) and continue to use them within 2 weeks before enrollment;\n\nHaving any uncontrollable clinical problems, including but not limited to:\n\nPersistent or active (severe) infections; Poorly controlled diabetes; Cardiac diseases (New York Heart Association class III\u002FIV congestive heart failure or heart block); The following conditions occurring within 6 months before the first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism.\n\nLarge amounts of pleural effusion or ascites with clinical symptoms requiring symptomatic treatment; Patients who received cytochrome P450 3A4 (CYP3A4) inhibitors within one week before screening; A history of stem cell transplantation or organ transplantation; Patients with a history of psychoactive substance abuse who are unable to abstain or a history of mental disorders; Other severe, acute or chronic medical diseases or laboratory test abnormalities that the researcher judges may increase the risks related to study participation or may interfere with the interpretation of study results; Patients judged by the researcher to have poor compliance, or other conditions that make them unsuitable for participating in this trial; A history of other malignant tumors within 5 years, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early-stage prostate cancer, and carcinoma in situ of the cervix.",{"count":50,"type":21},39,[25],"This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of Sacituzumab Tirumotecan and Toripalimab in the first-line treatment of recurrent\u002Fmetastatic head and neck squamous cell carcinoma patients with trop2 and CPS positive. The participants would receive Sacituzumab Tirumotecan and Toripalimab until termination criteria are met.",[28],"2026-06-17",{"date":56,"type":33},"2026-06-18",{"date":58,"type":33},"2025-07-29",{"date":60,"type":21},"2028-08-01",{"name":62,"class":63},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":80,"locationsCount":64},"100599886","phase-2-iparomlimab-and-tuvonralimab-in-hnscc-100599886","NCT07090317","Iparomlimab and Tuvonralimab in HNSCC","Iparomlimab and Tuvonralimab in Patients With Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma Failed Second-line Treatment:A Prospective, Single Arm, Phase II Trial","Inclusion Criteria:\n\n* Aged 18-75 years, regardless of gender; Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (with primary tumor sites in the oropharynx, oral cavity, hypopharynx, and larynx), with clinical or radiological progression after receiving 2 or more lines of anti-tumor systemic therapy in the recurrent or metastatic stage; ECOG performance status of 0 or 1; Expected survival period ≥ 12 weeks; At least one measurable lesion according to RECIST 1.1 criteria. Lesions that have undergone previous radiotherapy can be used as measurable lesions if disease progression occurs; Availability of tumor tissue for PD-L1 detection (paraffin-embedded specimens within 2 years or fresh tumor tissue); For patients with oropharyngeal cancer, the P16 detection status, determined by IHC method;\n\nNormal function of major organs within 2 weeks before treatment, meeting the following criteria:\n\nBone marrow function: Hemoglobin ≥ 100g\u002FL, white blood cell count ≥ 4.0×10\\^9\u002FL or neutrophil count ≥ 2.0×10\\^9\u002FL, and platelet count ≥ 100×10\\^9\u002FL without blood transfusion or colony-stimulating factor support; Liver function: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times the upper limit of normal; Renal function: Serum creatinine level \\\u003C 1.5 times the upper limit of normal or creatinine clearance rate ≥ 60ml\u002Fmin, and blood urea nitrogen ≤ 200mg\u002FL; Urinary protein \\\u003C +; if urinary protein is +, the 24-hour total protein must be \\\u003C 500mg; Blood glucose: Within the normal range and\u002For for diabetic patients, blood glucose is controlled in a stable state during treatment; Cardiac function: No myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency; For women of childbearing age, the serum pregnancy test result must be negative within 7 days before the first administration of the trial drug; males with reproductive capacity or females with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides) throughout the trial, and continue contraception for 12 months after the end of treatment.\n\nSubjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; Patients whom doctors believe can benefit from the treatment.\n\nExclusion Criteria:\n\n* Tumors outside the oropharynx, larynx, hypopharynx, or oral cavity; Previous treatment with anti-CTLA-4 drugs; Central nervous system metastasis and\u002For carcinomatous meningitis; Patients with hearing loss ≥ grade 2 or neuropathy ≥ grade 2 who are currently receiving anti-tumor treatment; Patients who participated in or are participating in other drug\u002Ftherapy clinical trials within 4 weeks before the first administration of the study drug; Patients who received hematopoietic stimulating factors (such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc.) within 1 week before the first administration of the study drug; Positive results of HIV antibody or Treponema pallidum antibody tests;\n\nPatients with active hepatitis B or hepatitis C:\n\nIf HBsAg or HBcAb is positive, additional HBV DNA testing is required (with the test result higher than the upper limit of the normal range); If HCV antibody test result is positive, additional HCV RNA testing is required (with the test result higher than the upper limit of the normal range); Active lung diseases (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active pulmonary tuberculosis;\n\nHaving any uncontrollable clinical problems, including but not limited to:\n\nPersistent or active (severe) infections; Poorly controlled diabetes; Cardiac diseases (New York Heart Association class III\u002FIV congestive heart failure or heart block); The following conditions occurring within 6 months before the first administration: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism; Large amounts of pleural effusion or ascites with clinical symptoms requiring symptomatic treatment; Patients who concurrently used cytochrome P450 3A4 (CYP3A4) inhibitors within one week before screening; A history of stem cell transplantation or organ transplantation; Patients with a history of psychoactive substance abuse who are unable to abstain or a history of mental disorders; Other severe, acute or chronic medical diseases or laboratory test abnormalities that the researcher judges may increase the risks related to study participation or interfere with the interpretation of study results; Patients judged by the researcher to have poor compliance, or other conditions that make them unsuitable for participating in this trial; A history of other malignant tumors within 5 years, except for cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, early-stage prostate cancer, and carcinoma in situ of the cervix.",{"count":73,"type":21},30,[25],"This study is a single center, non-randomized, prospective phase II clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab in patients with with recurrent\u002Fmetastatic head and neck squamous cell carcinoma failed second-line treatment. The participants would receive cetuximab combined with Iparomlimab and Tuvonralimab until termination criteria are met.",[28],{"date":56,"type":33},{"date":58,"type":33},{"date":60,"type":21},{"name":62,"class":63},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":64},"100624317","phase-2-a-comprehensive-multiomic-biomarker-evaluation-across-two-single-arm-cohorts-to-elucidate-mechanisms-of-response-and-resistance-in-recurrentmetastatic-rm-head-and-neck-squamous-cell-carcinoma-hnscc-100624317","NCT07408063","A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent\u002FMetastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma (HNSCC)","GSK5764227 (Anti-B7H3 Antibody Drug Conjugate) Monotherapy or in Combination With Dostarlimab in Recurrent\u002FMetastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma (HNSCC): a Multiomic Evaluation of Biomarkers of Response and Resistance (BeeHive)","BeeHive","Inclusion Criteria:\n\n1. Written informed consent\n2. At least 18 years old at the time of signing Informed Consent Form (ICF).\n3. Histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma (HNSCC) with evidence of metastatic or locally recurrent\u002Fadvanced disease not amenable to curative local therapy (surgery or radiation). Eligible primary tumor locations include oral cavity, oropharynx (p16 positive or negative), hypopharynx and larynx. Patients with unknown primary HNSCC, SCC of nasopharynx or paranasal sinuses are excluded.\n4. For oropharyngeal cancer, documented Human Papillomavirus (HPV) status (p16 Immunohistochemistry (IHC) or HPV DNA\u002FRNA) is required.\n5. At least one measurable lesion per RECIST v1.1\n6. ECOG performance status of 0 or 1.\n7. Life expectancy greater than 12 weeks.\n8. Cohort-Specific Criteria:\n\n   * Cohort A: R\u002FM HNSCC in the second- or third-line setting, pretreated with an Immune Checkpoint Inhibitor (ICI) and progressed on platinum-based therapy in the R\u002FM setting.\n   * Cohort B: R\u002FM HNSCC in the first-line setting, systemic therapy-naïve in the R\u002FM setting.\n9. Willingness and ability to undergo both a newly obtained, image-guided or surgical tumor biopsy during the screening period and a mandatory on-treatment tumor biopsy.\n10. No evidence of past or active hepatitis B infection, w\u002Fexception\n11. No evidence of active hepatitis C infection. Patients with undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) test are eligible.\n12. Participants must have no known history of HIV infection. HIV-1\u002F2 testing is only required for patients with known risk factors.\n13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other protocol requirements.\n14. Patients with feeding tubes (e.g. gastrostomy tubes) are eligible.\n15. Patients must have adequate organ function, as defined in protocol\n16. A female participant is eligible to participate if she meets all the criteria listed in protocol\n17. Male participants are eligible to participate if they agree to criteria listed in protocol during the study intervention period and for at least 5 months after the last dose of GSK5764227.\n\nExclusion Criteria:\n\n1. Participants with non-squamous histologies (e.g., adenocarcinoma, salivary gland carcinomas, and sarcomas) or HNSCC arising from the nasopharynx or paranasal sinuses are excluded. Participants with unknown primary tumors (even if squamous histology is confirmed) are also excluded.\n2. Has ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy (excluding, for example, alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy), or that the Investigator, with the agreement of the Study PI, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.\n3. Any participation in another investigational study within 4 weeks prior to screening.\n4. Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.\n5. Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.\n\n   \\- For dostarlimab: Patients requiring chronic systemic immunosuppressive therapy within 30 days prior to first dose are excluded, except for those receiving low-dose corticosteroids (≤10 mg\u002Fday prednisone equivalent), inhaled\u002Ftopical steroids, or physiological replacement therapy.\n6. Serious arteriovenous thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.) within 3 months prior to the first dose (w\u002Fexceptions)\n7. Evidence of brain metastasis unless all the following criteria are met:\n\n   * Asymptomatic.\n   * Medically stable for at least 4 weeks prior to initial dosing.\n   * No steroid treatment required for at least 2 weeks prior to initial dosing.\n   * No imaging evidence of severe edema located around the tumor lesion.\n   * Also excluded are untreated progression due to brain metastasis during or after the last treatment prior to screening, evidence of meningeal\u002Fbrainstem metastasis, or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).\n8. History of another primary solid tumor except for the following:\n\n   * Solid tumors that have been cured and inactive for ≥2 years before enrollment and at very low risk of recurrence.\n   * Prior HNSCC primary that has been curatively treated with no evidence of disease at enrollment.\n   * Adequately treated non-melanoma skin cancer or lentigo maligant without evidence of relapse.\n   * Adequately treated carcinoma in situ (e.g., cervix carcinoma in situ) without evidence of relapse.\n   * Definitively treated non-metastatic prostate cancer.\n9. Has had any major surgery (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dose of study intervention.\n10. History of prior allogeneic or autologous bone marrow transplant or solid organ transplant.\n11. Any of the cardiac examination abnormalities as listed in protocol.\n12. Serious or poorly controlled hypertension, including history of hypertensive crisis, hypertensive encephalopathy, adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose, or recurrent systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during the screening period.\n13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose, and:\n\n    * Receipt of any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including G-CSF, granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before enrollment, and\n    * Donation of blood or blood products more than 500 mL (approximately 1 pint) within 1 month prior to the first dose of study intervention.\n14. Serious infections within 4 weeks prior to the first dose, including but not limited to the list in protocol.\n15. Any history or current evidence of pulmonary disease\n16. History of severe neurological or psychiatric disorder (including, but not limited to, epilepsy, dementia, or major depression) or any serious and\u002For unstable medical, psychiatric, or other condition (including laboratory abnormalities) that, in the Investigator's judgment, could interfere with the participant's safety, ability to provide informed consent, protocol compliance, or the assessment of study outcomes.\n17. Has any active renal condition (e.g., requirement for dialysis, or any other significant renal condition that could affect the participant's safety).\n18. Allergy or hypersensitivity to any component of GSK5764227 (ADC, antibody, toxin GSK5757810); history of severe allergies (e.g., anaphylactic shock) or severe infusion-related reactions; or idiosyncrasy to recombinant humanized or mouse proteins. For Cohort B, this also includes allergy or hypersensitivity to dostarlimab or any of its components.\n19. Receipt of live vaccine within 30 days of the start of study intervention.\n20. Has any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the Investigator.\n21. Any of the following hepatic conditions:\n\n    * Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n    * Cirrhosis or current unstable liver or biliary disease per Investigator assessment, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n\n      o Note: Stable noncirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if the participant otherwise meets entry criteria.\n    * Documented presence of HBsAg, HBcAb, or HBsAb (except when HBsAb is attributable to previous vaccination) at screening or within 3 months prior to the first dose of study intervention.\n    * Positive HCV antibody test result at screening or within 3 months prior to the first dose of study intervention.\n\n      o Note: Participants with a positive HCV antibody test result due to prior resolved disease may be enrolled if a confirmatory negative HCV RNA test is obtained and the participant otherwise meets entry criteria.\n    * Positive HCV RNA test result at screening or within 3 months prior to the first dose of study intervention.\n\n      * Note: The HCV RNA test is optional; participants with a negative HCV antibody test are not required to undergo HCV RNA testing.\n22. Has received prior anticancer therapy and has not completed a washout period of at least 5 half-lives or 28 days, whichever is shorter, prior to the first dose of study intervention, or requires continued use these medications during the study.\n23. History of local palliative radiotherapy within 2 weeks prior to the first dose of study treatment. Extensive field radiotherapy requires a washout of 4 weeks prior to the first dose of study treatment.\n24. Concurrent use of the following medications within 7 days prior to the first dose of study intervention, or need to continue during the study",{"count":73,"type":21},[25],"The BeeHive study is an investigator-initiated, single center, open-label phase II clinical trial that is designed to conduct a comprehensive multiomic biomarker evaluation across two single-arm cohorts to elucidate mechanisms of response and resistance in recurrent and\u002For metastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC). It is anticipated that about 20 patients will be enrolled in Cohort A and an additional of 10 patients will be enrolled in Cohort B.",[28],"2026-04-28",{"date":95,"type":33},"2026-04-29",{"date":97,"type":33},"2026-04-27",{"date":99,"type":21},"2031-03-01",{"name":101,"class":63},"University Health Network, Toronto",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":64},"100620235","phase-2-a-single-arm-phase-ii-clinical-study-of-docetaxel-combined-with-nimotuzumab-and-pucotenlimab-as-second-line-and-beyond-therapy-for-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-100620235","NCT07354984","A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma","PIONEER-HN","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with no deterioration within 2 weeks prior to enrollment.\n2. Age ≥ 18 years and ≤ 75 years\n3. Patients with pathologically and\u002For radiologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx and larynx), who have previously failed treatment with PD-1 (L1) inhibitors and platinum-based drugs. The two types of drugs could be administered as a first-line combination regimen or sequential therapy, with the number of prior treatment lines not exceeding two. If disease progression occurs during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy, or within 6 months after the discontinuation of such treatment, the medications used during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy (including platinum-based drugs, anti-EGFR monoclonal antibodies, PD-1 (L1) inhibitors, etc.) shall be regarded as first-line treatment. Discontinuation or dose reduction of one drug during treatment, or replacement of platinum-based drugs, fluorouracil-based drugs or PD-1 (L1) inhibitors without disease progression shall be counted as the same line of treatment.\n4. At least one radiologically measurable lesion according to RECIST v1.1\n5. Assessed by the investigator as not amenable to local therapy (e.g., surgery ± radiotherapy)\n6. PD-L1 Combined Positive Score (CPS) ≥ 1\n7. Adequate organ function\n8. For women of childbearing potential, the result of serum or urine pregnancy test within 7 days prior to the first administration of the study drug shall be negative. If the urine pregnancy test result is positive or cannot be confirmed as negative, a serum pregnancy test shall be required for confirmation.\n9. The patient voluntarily participates in the study, signs the informed consent form, and is able to comply with the study schedule for follow-up visits, treatment plans, laboratory tests, and other research procedures.\n\nExclusion Criteria:\n\n1. A history of malignant tumor is known.\n2. Residual toxic reactions caused by prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, radiotherapy, etc.) (excluding alopecia, fatigue and grade 2 hypothyroidism), or clinically significant laboratory test abnormalities \\> grade 1 (CTCAE v5.0)\n3. Known to have active central nervous system metastases and\u002For carcinomatous meningitis. Patients with treated brain metastases may participate in the study, provided that their disease is stable.\n4. A history of severe hypersensitivity reactions to taxanes or other monoclonal antibodies.\n5. Has any contraindication to the study drugs of this project (docetaxel, nimotuzumab, and camrelizumab)\n6. Uncontrolled pleural, peritoneal, pelvic or pericardial effusion requiring drainage at least once a month.\n7. Uncontrolled or poorly controlled heart diseases, including a history of congestive heart failure (CHF) ≥ Grade 2 (per CTCAE v5.0 or NYHA classification), myocardial infarction, unstable angina pectoris, ventricular tachycardia or torsades de pointes within 6 months prior to enrollment, or cardiac arrhythmias requiring treatment, such as complete left bundle branch block or third-degree atrioventricular block.\n8. Pulmonary embolism or deep vein thrombosis occurring within 3 months prior to the first administration of the study drug (excluding catheter-related thrombosis from implanted ports or PICC lines)\n9. A history of or current interstitial pneumonia, severe chronic obstructive pulmonary disease complicated with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc.\n10. Any severe or uncontrolled systemic diseases, including uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg), diabetes mellitus (glycated hemoglobin (HbA1c) \\> 8%), etc.\n11. Patients with active bleeding, a history of coagulation disorders, or those receiving coumarin anticoagulant therapy.\n12. Known to have active hepatitis B or hepatitis C.\n13. Complicated with severe, uncontrolled infections, or known human immunodeficiency virus (HIV) infection (positive for HIV antibodies), or diagnosed with acquired immunodeficiency syndrome (AIDS); or with uncontrolled autoimmune diseases; or with a history of allogeneic tissue\u002Forgan transplantation, stem cell or bone marrow transplantation, or previous solid organ transplantation.\n14. Active bacterial, viral, fungal, rickettsial, or parasitic infections receiving systemic anti-infective therapy (unless treated and resolved prior to the administration of the study drug)\n15. Live virus vaccines administered within 30 days prior to the first dose of the study drug. The use of inactivated seasonal influenza vaccines or approved COVID-19 vaccines is permitted, provided that the interval between vaccination and the first dose of the study drug is more than 1 week.\n16. Receiving immunology-based therapy for any reason\n17. Pregnant or lactating female patients.\n18. Any other diseases, clinically significant laboratory parameter abnormalities, severe medical or psychiatric illnesses\u002Fconditions, or substance abuse including alcoholism that, in the investigator's judgment, may compromise patient safety, study integrity, affect patient participation in the study, or interfere with the study objectives and outcome analysis.",{"count":73,"type":21},[25],"This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1\u002FPD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.",[28],[114,115,116,117],"R\u002FM HNSCC","Second-line therapy","Immune Checkpoint Inhibitors","Salvage Therapy","NOT_YET_RECRUITING","2026-01-19",{"date":121,"type":33},"2026-01-21",{"date":123,"type":21},"2026-01-01",{"date":125,"type":21},"2029-12-31",{"name":127,"class":63},"Sun Yat-sen University",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":64},"100587961","phase-2-dalpicilib-plus-cetuximab-compared-with-cetuximab-alone-in-hpv-negative-anti-pd-1-resistant-rm-hnscc-100587961","NCT06935188","Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R\u002FM HNSCC","Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in Patients With HPV-negative, Anti-PD-1-resistant Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: An Open Label, Randomized Controlled, Phase II Trial","Inclusion Criteria:\n\n* Age 18-75 years, both sexes.\n* Patients with histologically confirmed post-surgical recurrent\u002Fmetastatic or locally advanced inoperable surgically resectable squamous cell carcinoma of the head and neck with measurable lesions (spiral CT scan ≥ 10 mm, meeting RECIST 1.1 criteria).\n* Have received at least 1 cycle of prior PD-1 immunotherapy with imaging confirmation of progression or clinician determination of no continued benefit from treatment; provided that this is completed at least 4 weeks prior to the first dose of study drug and all associated toxic events have returned to normal or grade I or less as defined by CTCAE 4.03 classification.\n* HPV viral testing determined to be negative, using the IHC method.\n* Availability of tumor tissue (paraffin specimens less than 2 years old or fresh tumor tissue) for detection of PD-L1 and CDK4-related genes.\n* ECOG score of 0 or 1.\n* Expected survival of ≥ 12 weeks.\n* Normal major organ function within 2 weeks prior to treatment, i.e., meeting the following criteria：Bone marrow function: hemoglobin ≥ 100 g\u002FL without transfusion or colony-stimulating factor support therapy, white blood cell count ≥ 4.0\\*10\\^9\u002FL or neutrophil count ≥ 2.0\\*10\\^9\u002FL, and platelet count ≥ 100\\*10\\^9\u002FL; Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal; Renal: blood creatinine level below 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml\u002Fmin and urea nitrogen ≤ 200 mg\u002FL; Urine protein \\\u003C+, or if urine protein + then total 24-hour protein must be \\\u003C500mg; Blood glucose: within normal range and\u002For with diabetes in treatment but under stable glycemic control; Pulmonary function: baseline FEV1 of at least 2L; if baseline FEV1 \\\u003C2L then FEV1 \\>800ml expected post-surgery as assessed by a surgical specialist; Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmias; no cardiac insufficiency.\n\nExclusion Criteria:\n\n* Patients previously treated with cetuximab or other anti-EGFR monoclonal antibodies or small molecule tyrosine kinase inhibitors.\n* Patients who are currently receiving antineoplastic therapy.\n* Patients who have participated or are participating in a clinical trial of another drug\u002Ftherapy within 4 weeks prior to the first dose of the study drug.\n* Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first dose of the study drug.\n* Positive HIV antibody or syphilis spirochete antibody test results.\n* Patients with active hepatitis B or C: If positive for HBsAg or HBcAb, additional HBV DNA testing (results above the upper limit of the normal range). If HCV antibody test result is positive, add HCV RNA test (result above the upper limit of the normal range).\n* Known hypersensitivity to recombinant humanized EGFR monoclonal antibody drugs and their components.\n* Massive pleural or ascites fluid with clinical symptoms and requiring symptomatic management.\n* Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis.\n* Has any uncontrollable clinical problem, including but not limited to: Persistent or active (severe) infection; Poorly controlled diabetes mellitus; Cardiac disease (Class III\u002FIV congestive heart failure or heart block as defined by the New York Heart Association); Deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism within 6 months prior to first dose.\n* Previous stem cell transplantation or organ transplantation.\n* Those with a history of psychotropic substance abuse and unable to abstain or a history of psychiatric disorders.\n* Other serious, acute or chronic medical conditions or abnormalities in laboratory tests that, in the judgment of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.\n* Patients who, in the judgment of the investigator, have poor compliance or other conditions that make them unsuitable for participation in this trial.\n* Patients with a history of other malignancies within five years.",{"count":136,"type":21},98,[25],"This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.",[28],"2025-07-15",{"date":142,"type":33},"2025-07-18",{"date":144,"type":33},"2025-04-17",{"date":146,"type":21},"2030-12-31",{"name":62,"class":63},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":64},"100461283","phase-2-a-study-of-pembrolizumab-mk-3475-plus-platinum-and-gemcitabine-as-first-line-treatment-of-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-piper-100461283","NCT05286619","A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma (PIPER)","PIPER","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of R\u002FM HNSCC that is considered incurable by local therapies will be enrolled in this study:\n\n   * Subject may not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.\n   * The eligible primary tumour locations are oropharynx, oral cavity, hypopharynx, and larynx.\n   * Subject may not have a primary tumour location site of nasopharynx (any histology).\n2. A male participant must agree to use a contraception as detailed in Appendix 3: Contraceptive Guidance and Pregnancy Testing of this protocol starting with the first dose of study treatment through the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n3. A female participant is eligible to participate if she is not pregnant (see Appendix 3: Contraceptive Guidance and Pregnancy Testing), not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3: Contraceptive Guidance and Pregnancy Testing OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3: Contraceptive Guidance and Pregnancy Testingduring the treatment period and for at least 180 days after the last dose of study treatment.\n4. The participant (or legally acceptable representative if applicable) willing and able to provides written informed consent for the trial. The participant may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.\n5. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n6. Archival or fresh tumor tissues must be available for evaluating relevant biomarkers. Newly obtained core needle or excisional biopsy of a tumor lesion not previously irradiated is preferred to archived tissue. If newly obtained samples cannot be obtained due to inaccessibility or patient safety concern, submission of paraffin block or formalin-fixed, paraffin embedded (FFPE) slides of up to 3 years prior to trial enrolment are acceptable (15 unstained slides of 5 microns in thickness). Refer to Section 6.1.5 for complete information on the tissue sample collection.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n8. Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days prior to the start of study intervention.\n\n   * Absolute neutrophil count (ANC) ≥1500\u002FµL\n   * Platelets ≥100 000\u002FµL\n   * Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FLa\n   * Creatinine ≤1.5 × ULN\n   * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n   * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n   * International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n1. Has disease that is suitable for local therapy administered with curative intent.\n2. Has progressive disease within six months of completion of curatively intended treatment for locoregionally advanced HNSCC.\n3. Patient with an expected life expectancy of less than 3 months.\n4. A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation (see Appendix 4). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).\n6. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to start of study treatment.\n\n   Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible Note: If the participant had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n7. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n8. 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.\n9. 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\n   Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n10. 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.\n11. Has a known additional malignancy that is progressing or has required active treatment within the past 5 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.\n12. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n13. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n14. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n15. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n16. Has an active infection requiring systemic therapy.\n17. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n18. 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.\n19. 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.\n20. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n21. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n22. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":156,"type":21},63,[25],"This is an open-label, single-arm, Phase 2 study of pembrolizumab plus platinum and gemcitabine (PG) in subjects with recurrent or metastatic head and neck cancer squamous cell carcinoma (R\u002FM HNSCC). Evaluable 63 subjects with R\u002FM HNSCC will be enrolled for examination of the efficacy and safety of the combination of pembrolizumab (200 mg IV on Day 1 of each 3-week cycle, up to 35 cycles) in combination with platinum (either cisplatin at 35 mg\u002Fm2 IV using a split-dose regimen on Day 1 and Day 8 or carboplatin at AUC 5 IV on Day 1 of each 3-week cycle, up to 6 cycles) and gemcitabine at 1250 mg\u002Fm2 IV on Day 1 and 8 of each 3-week cycle, for up to 6 cycles as first-line treatment. This study will be conducted in conformance with Good Clinical Practices. Specific procedures to be performed during the trial, as well as their prescribed timelines and associated visit windows, are outlined in the protocol.",[28],"2024-10-09",{"date":162,"type":33},"2024-10-15",{"date":164,"type":33},"2022-09-22",{"date":166,"type":21},"2028-12",{"name":168,"class":63},"University of Malaya"]