[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-head-and-neck-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-head-and-neck-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,86,114,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100534468","phase-2-pd-l1-t-hank-nai-il-15sa-and-cetuximab-for-recurrent-metastatic-hnscc-100534468",false,"NCT06239220","PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC","A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)","Inclusion Criteria:\n\n* Participants must have an existing histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) with evidence of recurrent, metastatic (R\u002FM) or locoregionally advanced, incurable or unresectable disease from any mucosal subsite including oral cavity, oropharynx, larynx, hypopharynx, nasal cavity, and the paranasal sinuses.\n* Participants must have at least one RECIST v1.1 measurable lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥ 1 cm with CT scans or MR imaging.\n* Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R\u002FM HNSCC; one of these lines should have included anti-PD-1\u002FL1 therapy.\n\n  * a.Platinum-based therapy as part of definitive\u002Fadjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy.\n  * b. At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (2 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE v5 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or peripheral neuropathy).\n* Be ≥18 years of age on the day of signing informed consent.\n* Must provide prior documentation on tumor PD-L1 expression status and HPV status (for oropharyngeal cancer cases), if available from the medical record.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale (see Appendix A).\n* Participants must have adequate organ and marrow function as defined below (within 14 days prior to study registration):\n\n  * a. ANC ≥1,000\u002FmcL\n  * b. Hemoglobin ≥9 g\u002FdL\n  * c. Platelets ≥100,000\u002FmcL\n  * d. Total bilirubin ≤ upper limit of normal (ULN)\n  * e. AST(SGOT)\u002FALT(SGPT) ≤2.5x institutional ULN (or ≤1.5x institutional ULN if concomitant with alkaline phosphatase \\>2.5x institutional ULN) or ≤5x ULN for those with liver metastases\n  * g. Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above 1.5x ULN\n* Baseline tumor measurements must be documented from imaging within 28 days prior to study registration.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects should not become pregnant or nurse a baby during the study and through 120 days after the last dose of study drugs. Male subjects should use a condom as a contraceptive during the study and through 120 days after the last dose of study drugs.\n\nSperm donation is discouraged for up to 6 months after the last dose of study drug.\n\n-Be willing and able to provide written informed consent for the trial.\n\nExclusion Criteria\n\n* Have been previously treated with 3 or more lines of systemic therapy for R\u002FM HNSCC.\n* Have received radiation therapy (RT) within 10 days of starting protocol therapy.\n* Solid organ transplant (allograft) recipients.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging and off systemic steroids for at least 3 weeks prior to study registration) and have no evidence of new or enlarging brain metastases.\n* A history of significant autoimmune disease as judged by the treating investigator and on active therapy including prednisone ≥10 mg daily dose equivalent of corticosteroids.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection; evidence of symptomatic congestive heart failure, unstable angina pectoris, stroke, or ventricular arrhythmia within 6 months of enrollment.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions might include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Any known positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative). Patients with HIV are eligible if their plasma HIV viral load is undetectable at baseline on antiretroviral therapy.\n* Subjects who are pregnant, or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Breastfeeding should be discontinued if the mother is treated on this protocol. Women who could potentially become pregnant while undergoing treatment on this protocol must be willing to use 2 methods of contraception.","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer.\n\nThe names of the therapies involved in this study are:\n\n* PD-L1 t-haNK cell therapy (a NK cell therapy infusion)\n* NAI (a type of recombinant human superagonist)\n* Cetuximab (a type of antibody)",[26,27,28,29,30,31],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Recurrent Head and Neck Cancer","Metastatic Head-and-neck Squamous-cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma",[26,27,28,29,30,31],"RECRUITING","2026-06-10",{"date":36,"type":37},"2026-06-11","ACTUAL",{"date":39,"type":37},"2024-02-16",{"date":41,"type":20},"2027-01-31",{"name":43,"class":44},"Glenn J. Hanna","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100403507","phase-2-a-clinical-trial-investigating-the-safety-tolerability-and-therapeutic-effects-of-bnt113-in-combination-with-pembrolizumab-versus-pembrolizumab-alone-for-patients-with-a-form-of-head-and-neck-cancer-positive-for-human-papilloma-virus-16-and-expressing-the-protein-pd-l1-100403507","NCT04534205","A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1","An Open-label Phase II\u002FIII Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1","AHEAD-MERIT","Key Inclusion Criteria:\n\n* Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.\n* Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.\n* Patients who have a tumor that expresses PD-L1 \\[CPS ≥1\\] as determined by the European Conformity (CE)-marked\u002FFood and Drug Administration-approved CDx PD-L1 immunohistochemistry 22C3 pharmDx performed according to the manufacturer's instructions for use.\n* Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 180 days prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed.\n* Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area may be considered measurable, if progression has been demonstrated in such lesions disease by RECIST 1.1.\n* All patients must provide a tumor tissue sample (formalin fixed paraffin embedded \\[FFPE\\] blocks or both slides and curls) from archival tissue. Alternatively, a fresh biopsy sample could be provided if a biopsy sample is performed as part of the patient's standard clinical practice before the first dose of trial treatment. The sample should be preferably derived from a current site of metastatic or recurrent disease. Otherwise, a sample from the primary tumor can be submitted.\n\nKey Exclusion Criteria:\n\nMedical conditions:\n\n* Patients present primary tumor site of nasopharynx (any histology).\n* Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, non-invasive superficial bladder cancer or breast ductal carcinoma in situ).\n\nPrior\u002Fconcomitant therapy:\n\n* Patients who have received or currently receive the following therapy\u002Fmedication:\n\n  1. Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone \\>10 mg daily orally \\[PO\\] or intravenously \\[IV\\], or equivalent) in the 7 days prior to the first dose of trial treatment.\n  2. Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) or five half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with immune-mediated AEs that have not resolved prior to the first dose of BNT113 or that pose an additional risk of on-trial complications, per investigator's assessment, or c) associated with toxicity that resulted in discontinuation of the immune-modulating agent and that poses an additional risk of on-trial complications, per investigator's assessment.\n  3. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113.\n  4. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or five half-lives of the agent (whichever is longer) before the planned first dose of BNT113.\n  5. Ongoing treatment with therapeutic PO or IV antibiotics. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) may be enrolled.\n* Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments, or any investigational agent within 4 weeks or five half-lives of the agent (whichever is longer) before the first dose of BNT113.\n* Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization. Note: Prior treatment with bone resorptive therapy, such as bisphosphonates (e.g., pamidronate, zoledronic acid) and denosumab, is allowed.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":55,"type":20},350,[23,57],"PHASE3","An open-label, controlled, multi-site, interventional, 2-arm, Phase II\u002FIII trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.\n\nThis trial has two parts.\n\nPart A, is an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.\n\nPart B, is a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab) within Part A.\n\nFor Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.\n\nPatients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months.",[60,28,29],"Unresectable Head and Neck Squamous Cell Carcinoma",[62,63,64,65,66,67,68,69,70,71,72,73,74],"Cancer vaccine","RNA vaccine","HNSCC","BNT113","Pembrolizumab","HPV16","Metastatic","Unresectable","Recurrent","Head and neck","mRNA vaccine","HPV-positive","Head and neck cancer","2026-05-20",{"date":77,"type":37},"2026-05-22",{"date":79,"type":37},"2021-01-07",{"date":81,"type":20},"2029-04",{"name":83,"class":84},"BioNTech SE","INDUSTRY",195,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100631512","phase-1-pembrolizumab-plus-ultrasound-induced-microbubble-cavitation-in-head-and-neck-cancer-100631512","NCT07501650","Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer","Feasibility Trial of Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n  1. Pathologically confirmed, HPV-negative, R\u002FM HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score \\> 1\n  2. The target lesion is ultrasound-accessible, biopsy-accessible, and measurable in at least one dimension, based on RECISTv1.1 criteria.\n  3. Male or female, aged ≥18 years of age\n  4. ECOG Performance status 0-2.\n  5. Must have a life expectancy of at least 6 months as judged by the treating physician.\n  6. Adequate organ function:\n\n     1. Absolute neutrophil count 1500\u002Fμl or more;\n     2. Platelets 100,000\u002Fμl or more,\n     3. Hemoglobin 8 g\u002Fdl or more;\n     4. Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin \\\u003C3 mg\u002Fdl);\n     5. AST and ALT less than or equal to 2.5x the upper limit of normal\n  7. Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG), which must also be confirmed as negative within 28 days of the start of study drugs.\n  8. Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 90 days after the last dose of study drugs. \"Women of reproductive potential\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, tubal ligation, or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL.\n  9. Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year. Men who are receiving the study medications will be instructed to adhere to contraception for 90 days after the last dose of study drugs. Men who are azoospermic do not require contraception.\n  10. Informed Consent: All subjects must be able to comprehend and sign a written informed consent document.\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Patients with HPV-positive or p16-positive SCC\n  2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or antiCTLA-4 antibody\n  3. Any history of allergy to the study drug components, including to polyethyleneglycol or medications containing polyethylene glycol.\n  4. Patients with the following cardiac conditions or history:\n\n     1. Patients with a known history of anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts\n     2. Patients with NYHA class III or greater heart failure, unstable anginal syndrome, or experiencing active chest pain.\n     3. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)\n     4. Patients who have experienced a STEMI or NSTEMI within the last 6 months\n     5. QTc \\>500 as determined by Fridericia correction\n     6. Patients with a history of ventricular arrhythmia that has not been corrected by placement of a PPM or ICD\n  5. Any concurrent malignancies: exceptions include- cutaneous basal cell carcinoma, chronic lymphocytic leukemia, melanoma in situ, squamous cell carcinoma of the skin of a secondary location, superficial bladder cancer or in situ cervical cancer that has undergone potentially curative therapy. Patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 2 years post-diagnosis.\n  6. Any unresolved toxicity CTCAEv5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with Grade ≥2 neuropathy will be evaluated on a caseby-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with anti-PD-1 therapy may be included only after consultation with the Study Physician.\n  7. Any subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 28 days of study drug administration., or a prior history of allogenic organ transplantation.\n  8. Any 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n  9. Patients must not be receiving any other investigational agents; must not have participated in a study of an investigational agent or be using an investigational device within 4 weeks of the first dose of Pembrolizumab plus Definity.\n  10. Receipt of a live attenuated vaccine within 30 days prior to the first dose of drug on trial.\n  11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n  12. Patients must not be pregnant or breastfeeding.\n  13. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1\u002F2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\]and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCVRNA.\n  14. Any untreated metastasis(es) to the brain that may be considered active.\n  15. History of pneumonitis within the past 5 years.",{"count":94,"type":20},6,[96],"PHASE1","This is a feasibility trial studying anti-PD-1 therapy (Pembrolizumab) among patients with R\u002FM HNSCC, delivered with ultrasound-induced microbubble cavitation, with the goal of optimizing delivery of Pembrolizumab and tumor response to Pembrolizumab. Patients will undergo 3 infusions of Pembrolizumab plus Definity 3 weeks apart. Following each infusion, ultrasound will be directed at the primary tumor site to induce microbubble cavitation, with the goal of tumor sonoporation. The primary endpoints will be feasibility, measured based on successful recruitment of 6 participants within 1 year of initiating recruitment, with successful completion of trial procedures among at least 80 percent of patients. Secondary endpoints will include proportion of serious adverse events, clinical\u002Fradiographic response, overall survival, and progression-free survival.",[26,99,28,29],"Head and Neck Small Cell Carcinoma",[70,66,101,102,103],"Pembro","Microbubble","Cavitation","2026-03-24",{"date":106,"type":37},"2026-03-30",{"date":108,"type":37},"2026-03-18",{"date":110,"type":20},"2028-03",{"name":112,"class":44},"Thomas Jefferson University",1,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":113},"100495975","evaluation-of-the-efficacy-and-safety-of-local-cryotherapy-treatment-of-recurrent-head-and-neck-cancer-in-irradiated-areas-a-pilot-study-100495975","NCT05738187","Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study","CRYORL","Inclusion Criteria:\n\n* Malignant head\u002Fneck tumor\n* Unresectable locoregional recurrence in a previously irradiated area\n* Contraindication to re-irradiation\n* Age \\> 18 years\n* Performance index ≤ 2 (WHO)\n* Life expectancy \\> 12 weeks\n* Absence of hemostasis disorders\n* Renal function: creatinine clearance ≥ 30 mL\u002Fmin by CKD-EPI method (Cockcroft-Gault formula or MDRD)\n* Subject affiliated to a social security health insurance plan\n* Subject able to understand the objectives and risks of the research and to give dated and signed informed consent\n* For a woman of childbearing age, negative blood pregnancy test at the inclusion visit\n\nExclusion Criteria:\n\n* Stage IV with distant metastases or multiple tumors\n* Melanoma, sarcoma, and lymphoma\n* Participants who have received chemotherapy or radiation therapy within 4 weeks\n* Other active cancer within the past 2 years (patients with carcinoma in situ, papillary thyroid carcinoma, basal cell skin carcinoma, localized Gleason 6 prostate cancer, or breast cancer in situ are allowed)\n* Concomitant therapy with any other systemic anticancer treatment\n* Contraindication of anaesthesiology character\n* Contraindication to MRI\n* Participation in another clinical study\n* Any social, medical or psychological condition that may prevent the patient from complying with the constraints of the protocol\n* Any significant pathology that may interfere with the patient's participation in the study\n* Subject under court protection\n* Subject under guardianship or curatorship\n* Pregnant or breastfeeding women",{"count":122,"type":20},15,[124],"NA","In France, squamous cell carcinomas of the head and neck (SCCHN) are the 5th most common cancer. 60% of patients present with locally advanced tumors (stage III\u002FIV), characterized by a poor prognosis (5-year survival not exceeding 60%). The standard treatment consists of either surgical removal followed by adjuvant radiochemotherapy or exclusive radiochemotherapy.\n\nIn case of locoregional recurrence (about 40% of patients), salvage surgery can be proposed, allowing prolonged survival for less than one third of eligible patients. However, more than half of locoregional recurrences are unresectable. The standard treatment then consists of immunotherapy and\u002For chemotherapy for palliative purposes with a median survival of no more than 15 months. Stereotactic radiotherapy is another potentially curative option that allows a local control of 30-60% at 1 year, but at the cost of significant toxicity (up to 50% of grade 3-4 toxicities), thus limiting its indication.\n\nThe issue of salvage treatment also applies to other rarer histological forms, including naso-sinus and salivary gland tumors, for which the probability of overall survival at 5 years does not exceed 65% due to locoregional evolution, despite advances in surgical techniques and the addition of radiotherapy.\n\nDuring the last two decades, minimally invasive interventional radiology techniques have been developed in the field of oncology. Among these techniques, cryotherapy is now commonly used for the treatment of several cancers. The multiplication of its indications is based on numerous clinical advantages (good post-operative analgesia, good toxicity profile, good tumor control). Cryotherapy could thus be a therapeutic alternative in head and neck cancers in recurrence situation in irradiated and unresectable territory, allowing to maintain a curative project in a higher proportion of patients and also to have a more favorable toxicity profile than re-irradiation.",[29,127],"Local Cryotherapy Treatment","2025-08-04",{"date":130,"type":37},"2025-08-08",{"date":132,"type":37},"2024-01-01",{"date":134,"type":20},"2028-05",{"name":136,"class":44},"University Hospital, Strasbourg, France",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100582911","phase-2-cetuximab-plus-platinum-and-taxane-based-chemotherapy-followed-by-avelumab-and-cetuximab-as-first-line-treatment-for-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-hnscc-patients-with-a-pd-l1-combined-positive-score-cps119-100582911","NCT06869473","Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19.","A Single-arm Phase II Study of Cetuximab Plus Platinum and Taxane-based Chemotherapy Followed by AVElumab and Cetuximab as First-line Therapy for Recurrent\u002FMetastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With PD-L1 Combined Positive Score (CPS)≥1≤19: the Immunotherapy Sequenc","AVEC-119","Inclusion Criteria:\n\n1. Subjects able to sign the informed consent and ≥18 y-old.\n2. Histologically or cytologically confirmed diagnosis of HNSCC.\n3. Confirmed R\u002FM HNSCC (i.e. oral cavity, oropharynx, larynx, hypopharynx) not suitable for curative loco-regional therapy.\n4. PD-L1 CPS≥1≤19 (assessment allowed either on primary and\u002For recurrent\u002Fmetastatic site of disease).\n5. Measurable disease according to RECIST Criteria 1.1.6. Subjects should not have had prior systemic therapy administered in the R\u002FM HNSCC setting.\n\n7.Systemic therapy that was completed more than 6 months prior to signing consent, if given as a part of multimodal curative treatment for locally advanced disease, is allowed.\n\n8.ECOG Performance Status (PS) 0-1. 9.Adequate bone marrow function: neutrophils ≥ 1.5 x 109\u002FL, platelets ≥ 100 x 109\u002FL, hemoglobin ≥ 9 g\u002FdL.\n\n10.Adequate liver function: total bilirubin level \\\u003C 1.5 X Upper Limit of Normal (ULN) (except for known medical reason not interfering with liver function, such as Gilbert syndrome), AP, GGT \\\u003C3 x ULN and AST and ALT levels ≤ 2.5 × ULN.\n\n11.Adequate renal function: calculated or analyzed creatinine clearance ≥ 30 mL\u002Fmin.\n\n12.Archival or fresh tissue of primary disease (i.e. T and\u002For N and\u002For M) OR recurrent\u002Fmetastatic disease available at baseline (before starting TPE) (available as Formalin-Fixed Paraffin-Embedded - FFPE - or as unstained 10-20 slices).\n\n13.Participants have to provide peripheral blood samples (at least 8-10 mL stored in EDTA) according the timing described in the translational part of the current protocol.\n\n14.Palliative radiotherapy and\u002For surgery within 4 weeks before the study entry are allowed.\n\n15.Symptomatic peripheral neuropathy NCI-CTC v5.0 grade ≥ 2 and \u002F or ototoxicity grade ≥ 2, (except for cases in which ototoxicity is due to trauma or tumor-related mechanical impairment) or creatinine clearance \\\u003C 60 mL\u002Fmin are acceptable and they must be approached with carboplatin (instead of cisplatin) since the trial start.\n\nExclusion criteria:\n\n1. Nasopharyngeal, salivary gland, nasal sinus, and non-melanoma skin cancers are not allowed.\n2. Life expectancy lower than 3 months according to the judgement of trial investigator is not allowed.\n3. Previous chemotherapy, or biological therapy (i.e. Cetuximab), or immunotherapy administered for R\u002FM setting of HNSCC is not allowed.\n4. Diagnosis of immunodeficiency or subjects receiving systemic steroid therapy (\\> 10 mg\u002Fday of prednisone or equivalent) or any other form of immunosuppressive therapy within 30 days prior to start of study treatment which cannot be interrupted.\n5. Known allergic\u002Fhypersensitivity reaction to investigational products or any component in their formulations.\n6. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n7. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with type I diabetes, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n8. Any diagnosed and\u002For treated additional malignancy within 5 years before the study entry with the exception of: curatively treated basal cell carcinoma of the skin, curatively treated squamous cell carcinoma of the skin, curatively treated prostate cancer, curatively resected in situ cervical cancer, and curatively resected in situ breast cancer.\n9. Subjects with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjects' participation for the full duration of the trial, or is not in the best interest of the subject to participate, according to the opinion of the treating investigator.\n10. Significant neurologic or known psychiatric or substance abuse disorders that would interfere with cooperation and the requirements of the trial.\n11. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (≤6 months prior to enrollment), myocardial infarction (≤6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n12. Prior organ transplantation including allogenic stem-cell transplantation.\n13. Active uncontrolled infection requiring systemic therapy (i.e. I.V. antibiotics).\n14. Known history of testing positive for HIV or known acquired immunodeficiency syndrome.\n15. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening tests positive).\n16. Live vaccination within 30 days of planned start of study treatment (inactivated vaccines are allowed).\n17. Pregnancy (absence of pregnancy must be confirmed by negative serum or urine pregnancy test - ß-HCG - for women of childbearing potential) and\u002For breast-feeding are not allowed. Subjects of childbearing potential willing to use effective contraceptive method \\[Pearl Index \\\u003C 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilization, sexual abstinence\\] for the entire study duration and 30 days post-dosing.",{"count":146,"type":20},67,[23],"This phase II interventional clinical trial aims to evaluate whether combining cetuximab and avelumab, after three cycles of platinum and taxane-based chemotherapy, can improve treatment outcomes for patients with recurrent or metastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC) with a PD-L1 combined positive score (CPS) between 1 and 19. Specifically, the study seeks to determine if this approach can increase the 6-month progression-free survival (PFS) rate from 40% to 55%.\n\nThe trial will include adult patients with confirmed R\u002FM HNSCC, who have not previously received systemic therapy for their advanced disease. By testing this sequential treatment strategy, researchers hope to improve outcomes for this specific patient population, which has shown poorer responses to existing immunotherapy options compared to those with higher PD-L1 expression levels.\n\nParticipants will first undergo an induction phase, consisting of three cycles of chemotherapy with paclitaxel, platinum (cisplatin or carboplatin), and cetuximab. After this initial treatment, they will move to a maintenance phase, where they will receive avelumab and cetuximab every two weeks until disease progression or the occurrence of unacceptable side effects.\n\nThe study aims to answer several key questions:\n\nCan this treatment approach improve progression-free survival at 6 months? What impact does it have on overall survival, response rates, and the duration of response? Is this combination therapy safe and well-tolerated? In addition to the treatment itself, participants will be asked to provide blood and tumor tissue samples for translational research, helping scientists better understand how biomarkers influence treatment response. Regular follow-up assessments will also be conducted to monitor disease progression and overall health.\n\nBy testing this innovative treatment sequence, researchers hope to bridge the gap between different PD-L1 subgroups, potentially offering a more effective and personalized approach for patients with R\u002FM HNSCC.",[150,29,28],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[152,153,154,155,156,157,158,159],"Head and Neck Neoplasms","Squamous Cell Carcinoma","Cetuximab","Avelumab","Anti-EGFR Therapy","Platinum-Based Chemotherapy","Taxane-Based Chemotherapy","PD-L1 Combined Positive Score (CPS)","2025-03-12",{"date":162,"type":37},"2025-03-14",{"date":164,"type":37},"2025-02-20",{"date":166,"type":20},"2028-02-20",{"name":168,"class":44},"Gruppo Oncologico del Nord-Ovest",8]