[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-or-metastatic-squamous-cell-carcinoma-of-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-or-metastatic-squamous-cell-carcinoma-of-head-and-neck":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100429137","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-mrg003-in-patients-with-recurrent-or-metastatic-squamous-cell-carcinoma-of-head-and-neck-100429137",false,"NCT04868162","A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck","An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.","Inclusion Criteria:\n\n* Willing to sign the ICF and follow the requirements specified in the protocol.\n* Expected survival time≥3 months.\n* Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of head and neck.\n* Failed prior platinum and\u002For anti-PD-1 treatment (Part A); failed or intolerant to at least one prior line of standard therapy (platinum-based regimen) (Part B)\n* Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* ECOG performance score 0 or 1.\n* Organ functions and coagulation function must meet the basic requirements.\n* Serum or urine pregnancy test negative within 7 days before the first dose of investigational drug.\n* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n* History of 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck.\n* ≥Grade 2 peripheral neuropathy\n* Prior anti-tumor therapy with MMAE\u002FMMAF ADCs\n* BMI≤17\n* Expected surgery or any other form of systemic or local anti-tumor therapy.\n* History of systemic chemotherapy within 3 weeks before the first administration of the investigational drug, targeted small molecule therapy within 2 weeks or 5 half-life periods before the first administration (whichever is shorter), antitumor biological therapy or immunotherapy within 4 weeks before the first administration, or major surgery.\n* Known active CNS metastasis and\u002For cancerous meningitis.\n* Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0). Prior Grade 3 to 4 immune-related AE (irAE) or ≥Grade 2 heart-related irAE.\n* Uncontrolled or poorly controlled heart disease.\n* History of pulmonary embolism or deep vein thrombosis within 3 months before the first administration of the investigational drug.\n* Known history of malignancy.\n* History of severe dermatosis.\n* Uncontrolled or poorly controlled hypertension.\n* Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy.\n* Known allergic reaction to any ingredients or excipients of investigational drugs.\n* Known active hepatitis B or C.\n* Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue\u002Forgan transplantation, stem cell or bone marrow transplantation, or solid organ transplantation.\n* Active bacterial, viral, fungal, rickettsia, or parasitic infections that require systemic anti-infective treatment.\n* Vaccination of live virus vaccine within 30 days before the first administration of the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed.\n* History of previous or concurrent interstitial pneumonia, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary dysfunction, symptomatic bronchospasm, etc.\n* Patients receiving immunology-based treatment for any reason.\n* Uncontrolled pleural effusion, pericardial effusion or recurrent ascites.\n* Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued.\n* Women who are lactating or pregnant.\n* Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.",[27],"Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck",[29,30,31,32,33],"MRG003","Squamous Cell Carcinoma of Head and Neck","EGFR","HX008","PD-1","RECRUITING","2025-07-02",{"date":37,"type":38},"2025-07-08","ACTUAL",{"date":40,"type":38},"2021-04-23",{"date":42,"type":21},"2026-12",{"name":44,"class":45},"Shanghai Miracogen Inc.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100565326","phase-2-study-of-tpex-followed-by-a-maintenance-with-avelumab-and-cetuximab-in-first-line-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-hn-100565326","NCT06640725","Study of TPEx Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the H&N","A Phase II Study of TPEx (Taxotere-platinum-cetuximab) Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (TATIANA)","TATIANA","Inclusion Criteria:\n\n1. Adult men and women ≥ 18 years and \\< 75 years.\n2. Histologically confirmed recurrent and\u002For metastatic SCCHN (oral cavity, pharynx, larynx), not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy); squamous cell carcinoma of unknown primary if HPV positive.\n3. Detection of PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) SCCHN tissue samples determined by Combined Positive Score (CPS) ≥1 using local IHC assay.\n4. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n5. Patients without contra indication to TPEx (either with cisplatin or carboplatin), to docetaxel, cetuximab and to immunotherapy (avelumab).Investigators must refer to the last updated version of Summary of product Characteristics (SPC) of the products.\n6. Documentation of p16 status as surrogate of human papillomavirus (HPV) status of tumor for SCC of the oropharynx.\n7. Measurable disease by CT or MRI per RECIST 1.1 criteria.\n8. In case of radiotherapy given without systemic treatment, prior curative radiation therapy must have been completed at least 4 weeks before TPEx administration and\u002For prior palliative radiotherapy must have been completed at least 2 weeks before TPEx administration.\n9. Screening laboratory values must meet the following criteria (using NCI-CTCAE v5) and should be obtained within 14 days prior to eligibility check:\n\n   1. WBC \\> 2000\u002FμL\n   2. Polynuclear neutrophils \\>1.5 x 109\u002FL\n   3. Platelets \\> 100 x 109\u002FL\n   4. Hemoglobin \\> 9.0 g\u002FmL\n   5. ALAT\u002FASAT\\< 3.0 x ULN in the absence of liver metastases or \\< 5x ULN in the presence of liver metastases\n   6. Bilirubin \\< 1.5 x ULN (except Gilbert Syndrome: \\< 3.0 mg\u002FdL)\n   7. Creatinine clearance \\> 60 mL\u002Fmin (measured or calculated by preferably Cockcroft and Gault formula) for cisplatin administration and creatinine clearance between ≥ 40 mL\u002Fmin and ≤ 60 mL\u002Fmin (measured or calculated by preferably Cockcroft and Gault formula) for carboplatin administration.\n10. Calcium levels must be normalized and maintained within normal limits for study entry. Medical management of calcium levels is permitted. Note: Normal calcium levels may be based on ionized calcium or adjusted for albumin.\n11. Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically non-significant by the Investigator and\u002For stable on supportive therapy.\n12. Women of childbearing potential must have a negative serum or urine pregnancy test at the eligibility check. The pregnancy test must be done within 72 hours before eligibility check.\n13. Both men and women (of childbearing potential) who are sexually active must agree to use highly effective contraceptive method(s) from ICF signature to at least 7 months post-treatment for women and 4 months post-treatment for men.\n\nExclusion Criteria:\n\n* 1.Prior systemic chemotherapy for the head and neck carcinoma, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry.\n\n  2.Histologically confirmed recurrent or metastatic carcinomas of the nasopharynx, squamous cell carcinoma of unknown HPV negative primary, or salivary gland or non-squamous histologies (e.g., mucosal melanoma) are not allowed.\n\n  3.Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.\n\n  4.Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n\n  5.Subjects with active, known or suspected autoimmune disease. Subjects with stabilized type I diabetes mellitus under treatment, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n\n  6.Subjects with a condition requiring systemic chronic administration of corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of eligibility check. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n\n  7.Patients having received prior therapy with anti-PD1, anti-PD-L1(or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n\n  8.Prior anti-EGFR treatment received less than 6 months before eligibility check.\n\n  9.Patients with known positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n\n  10.Patients with known positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.\n\n  11.Use of non-oncology vaccines containing live virus or bacteria for prevention of infectious diseases within 4 weeks prior to eligibility check. The use of the inactivated seasonal influenza vaccine is allowed.\n\n  12.History of severe hypersensitivity reaction to any human monoclonal antibody.\n\n  13.Severe concurrent psychiatric conditions that would limit compliance with study requirements.\n\n  14.Serious systemic infection requiring hospital treatment with intravenous antibiotics within 14 days prior eligibility check.\n\n  15.History of organ transplant. 16.Patients presenting hemorrhagic tumor, only if carboplatin is administrated. 17.Concomitant phenytoin and fosphenytoin medication during the study treatment period.\n\n  18.History of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose).\n\n  19.Interstitial lung disease. 20. History of uncontrolled or symptomatic cardiac disease. 21. Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship.","74 Years",{"count":57,"type":21},70,[24],"The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment.\n\nAll participants in this research will receive the same treatment which will take place in two phases:\n\n* 1st phase chemotherapy + immunotherapy: standard reference treatment (Docetaxel + cisplatin or carboplatin + cetuximab)\n* 2nd phase immunotherapy: cetuximab combined with avelumab which is the treatment under study.",[27],"2025-01-14",{"date":63,"type":38},"2025-01-15",{"date":65,"type":38},"2025-01-02",{"date":67,"type":21},"2028-12-02",{"name":69,"class":70},"Groupe Oncologie Radiotherapie Tete et Cou","OTHER"]