[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Groupe Oncologie Radiotherapie Tete et Cou\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,72,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100613245","phase-3-study-comparing-ivonescimab-alone-or-ivonescimab-in-combination-with-ligufalimab-versus-pembrolizumab-for-the-treatment-of-scchn-100613245",false,"NCT07264075","Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN","A Randomized, Open-label, Multicenter, Phase 3 Trial of Ivonescimab Alone or With Ligufalimab Versus Pembrolizumab in First-line Recurrent and\u002For Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","ILLUMINE","Inclusion Criteria:\n\n1. Patient capable of voluntary giving her\u002Fhis written informed consent.\n2. Age ≥ 18 and \\\u003C 80 years old at the time of enrolment.\n3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.\n4. Expected survival ≥ 6 months at randomization.\n5. Patient is histologically and\u002For cytologically confirmed to have r\u002Fm HNSCC (according to the International Union Against Cancer and the American Joint Committee on Cancer 8th edition staging system) with a primary tumour initially or currently located in the oral cavity, oropharynx, hypopharynx, or larynx.\n6. HPV status test results based on tumour tissue samples must be obtained prior to randomization for patients with oropharyngeal cancer.\n7. No prior systemic anti-tumour therapy for R\u002FM HNSCC. Note: Patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy with curative intent for non-metastatic disease, radiotherapy, or radical radiotherapy in combination with chemotherapy or cetuximab\u002FEGFR based therapy for locally advanced disease are eligible for this study if disease progression occurs \\> 6 months after the end of the last treatment.\n8. At least one measurable lesion according to RECIST v1.1, or measurable lesion with clear radiographic progression after local therapy, and the lesion must be suitable for repeated accurate measurements (see Appendix 3).\n9. Tumours must be PD-L1 positive (CPS ≥ 1) as confirmed by CE-IVD immunohistochemistry assay based on local assessment with any assay validated for HNSCC in a laboratory compliant with National provisions. The measurement of PD-L1 protein expression can be performed based on archival tissue sample before the diagnosis of R\u002FM tumour or based on tissue sample obtained after the diagnosis of a R\u002FM tumour.\n10. Good organ function is determined by the following requirements:\n\n    a.Haematology (satisfactory laboratory test results obtained during the screening period, and no blood components used within 14 days of cell growth factor supportive therapy): i.Absolute neutrophil value (ANC) ≥ 1.5×109\u002FL (1,500\u002Fmm3) ii.Platelet count ≥ 100×109\u002FL (100,000\u002Fmm3) iii.Haemoglobin ≥ 10 g\u002FdL b.Kidneys: i.Calculated creatinine clearance (Appendix 4) ≥ 50 mL\u002Fmin ii.Urine protein ≤ 2+ or 24 hours (h) urine protein quantification \\\u003C 1.0 g c.Liver: i.Serum total bilirubin ≤ 1.5× upper limit of normal (ULN); for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, ≤ 3 × ULN ii.AST and ALT ≤ 2.5×ULN; For patients with liver metastases, AST and ALT ≤ 5×ULN iii.Serum albumin ≥ 28 g\u002FL d.Coagulation function: International normalized ratio (INR) and\u002For activated partial thromboplastin time (APTT) ≤ 1.5× ULN. This applies only to patients who are not on therapeutic anti- coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n\nExclusion Criteria:\n\n1. Primary tumour site (any histology) of nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid glands, skin, or unknown primary site of tissue origin.\n2. Patient with malignancies other than HNSCC within 3 years prior to enrolment. Patients with other tumours that have been cured through local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded.\n3. Concurrent enrolment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study; Received study treatment within 4 weeks prior to randomization.\n4. Prior treatment with systemic anti-angiogenic drugs.\n5. Previous head and neck re-irradiation for recurrent\u002Fmetastatic disease\n6. Prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1 antibody, anti- CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, anti-CD47, anti-SIRPα, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment that targets tumour immunity including therapeutic tumour vaccine, and other adjuvant\u002Fneoadjuvant anti-PD-1 based therapy.\n7. Patients with ulcers on the skin surface related to the current cancer during the screening period, superficial or protruding skin lesions with excessive surface tension and a greater risk of ulceration, or other patients with a greater risk of ulceration as assessed by the investigator. Patients with recent tracheostomy involving the tumour which are at risk of bleeding.\n8. Imaging during the screening period shows that the tumour invades\u002Finfiltrates the surrounding important organs (such as trachea, oesophagus, and based on investigator assessment ofbleeding risk) and\u002For large blood vessels in the neck (such as subclavian artery, common internal and\u002For external carotid artery, etc.) or if the investigator judges that entering the study might cause a potential risk of bleeding.\n9. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, or leptomeningeal disease.\n10. Received curative head and neck radiotherapy within 6 months prior to randomization. Palliative local treatment for non-head and neck areas carried out within 3 weeks before randomization; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymus peptide, tumour necrosis factor, etc.) within 2 weeks prior to randomization, excluding IL-11 for the treatment of thrombocytopenia.\n11. Presence of active autoimmune disease requiring systemic therapy (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years prior to randomization. Alternative therapies (e.g., thyroxine, insulin, or those targeting the adrenal glands or pituitary) and physiologic corticosteroid replacement therapy for pituitary insufficiency are not considered systemic treatment.\n12. History of immunodeficiency; Those who have history of positive test for HIV antibodies; Current long-term use of systemic corticosteroids or other immunosuppressants is excluded.\n13. Previous or current non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy, or current presence of lung diseases including but not limited to the following: pneumoconiosis, silicosis, drug-related pneumonia, pulmonary diseases with severe impairment of lung function, etc.\n14. Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active non-severe infection that has received systemic anti-infective therapy within 2 weeks prior to randomization.","ALL","18 Years","80 Years",{"count":21,"type":22},780,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a randomized, open-label, active-comparator-controlled, multi-regional, three-arm, phase 3 study comparing the efficacy and safety of ivonescimab in combination with ligufalimab to pembrolizumab and of ivonescimab alone to pembrolizumab as first-line treatment in patients with recurrent or metastatic (R\u002FM) PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).\n\nThe objective of this study is to improve first-line survival in patients with recurrent or metastatic PD-L1-positive HNSCC (CPS ≥ 1). Overall survival (OS) was chosen as the primary endpoint.\n\nPatients will receive the following treatment regimens in accordance with the study treatment plan until disease progression, death, intolerable toxicity, or the occurrence of another protocol-specified treatment discontinuation criterion, whichever occurs first.\n\n* ARM A: Ivonescimab (10 mg\u002Fkg iv, 60 min ± 10 min infusion, Q3W)\n* ARM B: Ivonescimab (10 mg\u002Fkg iv, 60 min ± 10 min infusion, Q3W), and ligufalimab (45 mg\u002Fkg iv, 120 min ± 15 min infusion, Q3W).\n* ARM C (control arm): Pembrolizumab (200 mg iv, 60 min ± 10 min infusion, Q3W). The total duration of treatment is up to 24 months",[28],"Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)",[30],"first-line recurrent and\u002For metastatic","RECRUITING","2026-05-18",{"date":34,"type":35},"2026-05-20","ACTUAL",{"date":37,"type":35},"2026-05-05",{"date":39,"type":22},"2030-05",{"name":41,"class":42},"Groupe Oncologie Radiotherapie Tete et Cou","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100633683","phase-2-phase-ii-study-of-ficerafusp-alfa-in-combination-with-nivolumab-in-patients-with-platinum-refractory-head-and-neck-squamous-cell-carcinoma-100633683","NCT07529873","Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma","A Phase II Study of Ficerafusp Alfa (BCA 101) in Combination With Nivolumab in Platinum Refractory Head and Neck Squamous Cell Carcinoma Patients Who Progressed Within 6 Months After Multimodal Treatment for Locally Advanced Disease ( BICARA)","N'FORCE","Inclusion Criteria:\n\n* Patient or legally authorized representative, if applicable, has signed and dated informed consent form (ICF) indicating that the patient (or legally authorized representative, if applicable) has been informed of all the pertinent aspects of the study prior to enrollment and the patient must be willing to comply with all study procedures for the duration of the study.\n* Patient is \\>18 years, ≤75 years of age on the day the ICF is signed.\n* Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (see Appendix 1).\n* Histologically or cytologically confirmed squamous cell carcinoma of head and neck (HNSCC). Eligible primary tumor locations are oral cavity, larynx hypopharynx, or oropharynx (OPSCC).\n* Local, regional or metastatic progression within 6 months after the last dose of platinum in a multimodal strategy for locally advanced stage, not amenable to salvage surgery in case of local or regional progression.\n\nSpecification regarding inclusion criterion no. 05 : Progression is not assessed as per RECIST. Any of the following will be considered as progression:\n\n* A positive biopsy 3 months after the end of radiotherapy given with curative intent\n* Appearance of any new lesion (e.g.: metastases or lymph nodes)\n* Any increase in tumor size\n* Any persisting tumor (confirmed with a biopsy) not amenable to salvage surgery\n* For OPSCC patients, a pathological report determination of human papillomavirus (HPV) status by p16 expression must be p16 negative -Measurable tumor lesion(s) assessed by H\\&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1 (see Appendix 3). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated.\n\nExclusion Criteria:\n\n* Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity or salivary gland, thyroid or parathyroid gland pathologies, skin, squamous cell carcinoma of unknown primary or non-squamous histologies (e.g., mucosal melanoma).\n* Patients having received prior systemic treatment for metastatic or recurrent disease.\n* Patients having received prior treatment with anti-EGFR antibody.\n* Patients having received prior treatment with anti-TGF-β therapy.\n* 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* Known to be diagnosed and\u002For treated for any other additional malignancy within 2 years prior to registration\u002Frandomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1 up to T2a with a Gleason score ≤6 and prostatic specific antigen \\\u003C10 ng\u002FmL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to registration\u002Frandomization. Other exceptions may be considered with the Sponsor's consultation. The time requirement for no malignancy for 2 years does not apply to the cancer for which a patient is enrolled in the study.\n* Any of the following \\\u003C6 months before starting study treatment: ST-elevation myocardial infarction, severe\u002Funstable angina, uncontrolled cardiac ventricular arrythmia, coronary\u002Fperipheral artery bypass graft or stent, cerebrovascular accident\u002Fstroke less than 6 months prior to enrollment or NYHA Class III\u002FIV congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically stable can enroll if they are on a stable dose of anticoagulants for at least 3 months.\n* Serious systemic infection (bacterial, viral, or fungal) within 4 weeks before first dose of study treatment, or active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.\n* History of (non-infectious) pneumonitis\u002F interstitial lung disease or has current pneumonitis\u002F Interstitial lung disease.\n* Active central nervous system (CNS) metastases or carcinomatous meningitis. Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded. Patients with a history of treated central nervous system metastases (by surgery or radiation therapy) may be eligible if central nervous system metastases have been stable for at least 4 weeks, i.e., without evidence of progression by repeat imaging and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n* History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance.","75 Years",{"count":54,"type":22},131,[56],"PHASE2","This is a multicenter study comprising two phases: a run-in phase, including only patients receiving ficerafusp alfa and nivolumab, and a randomized phase, which corresponds to a randomized, open-label, phase II comparative study.\n\nThe primary objective is to compare the objective response rate (ORR) of patients with platinum refractory HNSCC with progressive disease within the 6 months after multimodal curative treatment treated with ficerafusp alfa (BCA 101) and nivolumab versus nivolumab alone.\n\nThere is a strong medical justification for combining ficerafusp alfa with nivolumab (anti-PD-1) to provide additional clinical benefit to patients with platinum-refractory HNSCC who are progressing within 6 months of multimodal treatment for locally advanced disease.\n\nIn the Run-in phase, patients will receive the following treatment regimens according to the study intervention plan:\n\nCombination of Ficerafusp alfa + Nivolumab\n\n* Ficerafusp alfa 1500 mg every week\n* Nivolumab 240 mg every 2 weeks\n\nIn the randomized trial:\n\n* ARM A Combination of Ficerafusp alfa + Nivolumab Ficerafusp alfa 1500 mg every week Nivolumab 240 mg every 2 weeks\n* ARM B Nivolumab monotherapy Nivolumab 240 mg every 2 weeks",[59],"Squamous Cell Carcinoma of Head and Neck (SCCHN)",[61,62],"head and neck squamous cell carcinoma","locally advanced disease.","NOT_YET_RECRUITING","2026-04-07",{"date":66,"type":35},"2026-04-14",{"date":68,"type":22},"2026-05",{"date":70,"type":22},"2030-12",{"name":41,"class":42},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":43},"100589799","phase-2-clinical-trial-comparing-induction-treatment-with-egfr-adc-mrg003-alone-or-in-combination-with-the-anti-pd1-pucotenlimab-followed-by-radiochemotherapy-in-locally-advanced-squamous-cell-cancers-of-the-head-and-neck-100589799","NCT06959108","Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck","Randomized Phase 2 Trial of Induction Treatment of Anti-PD-1 Pucotenlimab and EGFR-ADC MRG003 Versus EGFR-ADC Alone Followed by Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN).","IDEAL","Inclusion Criteria:\n\n* Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Evaluable tumor burden assessed by H\\&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1\n* Patients eligible to cisplatin-based chemotherapy\n* No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCICTCAE v.5\n* No prior treatment with chemotherapy, immunotherapy and targeted therapy for H\\&N cancer, radiotherapy or surgery in the head and neck region.\n\nExclusion Criteria:\n\n* Metastatic disease (stage IVC as per AJCC\u002FTNM, 8th Ed.).\n* Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways).\n* Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment\n* History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ nonmuscular invasive bladder, cervix, uterine and\u002For prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum\u002Fanus.\n* Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction \\\u003C 50%.\n* Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Patients with positive tests for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Presence of other serious liver diseases, including chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis.",{"count":81,"type":22},106,[56],"The primary objective of this study is to compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti PD-1 Pucotenlimab versus EGFR-ADC MRG003 alone before chemoradiotherapy.\n\nPeople eligible to participate in this study must be between the ages of 18 and 75 and have locally advanced squamous cell carcinoma of the head and neck requiring treatment with chemoradiotherapy (cisplatin combined with radiotherapy).\n\nHalf of the research participants will receive MRG003 alone as induction before radiochemotherapy and the other half will receive MRG003 combined with pucotenlimab as induction before radiochemotherapy, then pucotenlimab as adjuvant\\* after radiochemotherapy.",[85],"Locally Advanced Head and Neck Squamous Cell Carcinoma","2026-04-01",{"date":64,"type":35},{"date":89,"type":35},"2025-10-13",{"date":91,"type":22},"2029-10",{"name":41,"class":42},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":43},"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":103,"type":22},70,[56],"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.",[107],"Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck","2025-01-14",{"date":110,"type":35},"2025-01-15",{"date":112,"type":35},"2025-01-02",{"date":114,"type":22},"2028-12-02",{"name":41,"class":42},""]