[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-oropharyngeal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-oropharyngeal-squamous-cell-carcinoma":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"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":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100561410","phase-3-testing-the-addition-of-anti-cancer-drug-cetuximab-to-standard-of-care-treatment-pembrolizumab-for-returning-or-spreading-head-and-neck-cancer-after-previous-treatment-100561410",false,"NCT06589804","Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment","Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab\u002FCetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease","Inclusion Criteria:\n\n* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).\n* Previously untreated for recurrent and\u002For metastatic disease incurable by local therapies.\n* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.\n\n  * Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.\n* Measurable disease.\n* Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.\n* Patient must have a combined positive score PD-L1 positive (CPS \\>\u002F= 1) tumor.\n* Any radiation therapy must be completed \\>= 10 days prior to registration.\n* Patients should not have received any prior treatment in the recurrent or metastatic setting.\n* Prior therapy with neoadjuvant or induction anti PD-1\u002FPD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \\>= 26 weeks prior to registration without evidence of disease progression during that treatment period.\n* Patient has not received a live vaccine within 30 days prior to registration.\n* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).\n* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.\n* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and\u002For HPV in situ hybridization (ISH).\n\n  * Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.\n* Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3.\n* Platelet count ≥ 100,000\u002Fmm\\^3.\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL (if \\\u003C 9 g\u002FdL, then transfusions are acceptable to increase hemoglobin above 9 g\u002FdL).\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL\u002Fmin using the Cockcroft-Gault formula for participant with creatinine levels \\> 1.5 x institutional ULN.\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \\\u003C ULN for participant with total bilirubin \\> 1.5 x institutional ULN.\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x ULN unless liver metastases are present in which case \\\u003C 5.0 x ULN.\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n* For treated\u002Fstable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n\n  * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Patients does not have a history of active myocarditis.\n* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.\n* Patient does not have a history of solid organ transplantation.","ALL","18 Years",{"count":19,"type":20},158,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and\u002For that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and\u002For metastatic HNSCC than pembrolizumab alone.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Neck Squamous Cell Carcinoma of Unknown Primary","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Refractory Head and Neck Squamous Cell Carcinoma","Refractory Hypopharyngeal Squamous Cell Carcinoma","Refractory Laryngeal Squamous Cell Carcinoma","Refractory Oral Cavity Squamous Cell Carcinoma","Refractory Oropharyngeal Squamous Cell Carcinoma","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","RECRUITING","2026-06-10",{"date":50,"type":51},"2026-06-11","ACTUAL",{"date":53,"type":51},"2025-03-27",{"date":55,"type":20},"2029-11-30",{"name":57,"class":58},"National Cancer Institute (NCI)","NIH",177,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":71,"conditions":72,"keywords":83,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100484019","phase-1-autologous-t-cells-targeting-hpv16-hpv18--survivin-in-patients-with-rr-hpv-related-oropharyngeal-cancers-100484019","NCT05582590","Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R\u002FR HPV-related Oropharyngeal Cancers","A Phase 1 Open-Label Dose-Escalation Study of the Safety of Adoptively Transferred Autologous CD8+ T Lymphocytes Targeting HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 and Survivin in Patients With Relapsed or Refractory HPV-related Oropharyngeal Cancers","Inclusion Criteria:\n\n1. The patient will be typed for HLA-A\\*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor.\n2. Patients with cytologically or histologically confirmed locally advanced or metastatic HPV related oropharyngeal cancers with confirmed detection of HPV-16 and\u002For HPV-18.\n3. Patients with HPV-related oropharyngeal cancers who have received at least 1 prior line of standard-of-care (SOC) treatment (for example, per the current NCCN Guidelines for Patients with Oropharyngeal Cancer) consisting of systemic immunotherapy and\u002For chemotherapeutic treatment.\n\n   1. The last dose of cytotoxic chemotherapy and\u002For steroids must be administered at least 28 days prior to the leukapheresis procedure.\n   2. Any adverse event(s) that the patient may have experienced from prior therapy must have resolved to ≤ Grade 1 according to NCI CTCAE version 5.0.\n4. Measurable disease per RECIST v1.1 criteria (at least 1 lesion that can be measured accurately in at least 1 dimension with the longest diameter ≥ 10 mm \\[MRI or CT scan sliced thickness ≤ 5 mm\\]).\n5. Pulse oximetry ≥ 92% on room air.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Life expectancy of at least 3 months.\n8. Be willing to comply with the study schedule and all other protocol requirements.\n9. Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have 2 negative pregnancy tests prior to treatment. All sexually active WOCBP and all sexually active male patients must agree to use highly effective methods of birth control throughout the study.\n10. Ability of the patient to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment. Patients taking adjuvant hormonal therapy for definitively treated cancers (e.g., breast cancer, prostate cancer) are eligible.\n2. Major surgery within 28 days prior to the first study drug administration (minimally invasive procedures, such as diagnostic biopsies, are permitted).\n3. Known central nervous system involvement.\n4. Treatment with an allogeneic hematopoietic stem cell transplantation.\n5. Treatment with any investigational agent(s) at the time of informed consent.\n6. Left ventricular ejection fraction (LVEF) \\\u003C 45%, congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.\n7. The following hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support):\n\n   1. Hemoglobin \\\u003C 9.0 g\u002FdL.\n   2. Platelet count \\\u003C 100,000\u002FμL.\n   3. Absolute neutrophil count (ANC) \\\u003C 1000\u002F μL.\n8. The following chemistry laboratory results at Screening:\n\n   1. Serum creatinine ≥ 1.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) ≤ 50 mL\u002Fmin\u002F1.73 m\\^2.\n   2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3x the upper limit of normal (ULN) or serum total bilirubin \\> 2 mg\u002FdL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome).\n9. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\> 1.5x ULN within 1 week prior to the start of lymphodepletion chemotherapy, unless on a stable dose of an anticoagulant.\n10. Are pregnant or breastfeeding.\n11. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment.\n\n    1. Inactivated annual influenza vaccination is allowed.\n    2. Vaccines such as COVID-19 vaccine, e.g., SARS-CoV-2 vaccine \\> 7 days before administration is acceptable. For vaccines requiring more than 1 dose, the full regimen should be completed prior to Cycle 1 Day 1.\n12. Active bacterial, viral, or fungal infection within 72 hours of the start of lymphodepletion chemotherapy; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection.\n13. Have human immunodeficiency virus (HIV) active infection as indicated by positive HIV polymerase chain reaction (PCR) test, human T-cell leukemia virus type 1 infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being hepatitis B surface antigen \\[HbsAg\\] positive, or anti-HBe-antibody positive), or are positive for HBV DNA. HCV ribonucleic acid (RNA) must be undetectable by laboratory test.\n14. Any condition including the presence of laboratory abnormalities, that places the patient at an unacceptable risk if the patient was to participate in the study.\n15. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n    Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.\n16. Patients who experienced the following immune checkpoint inhibitor-related AEs even if the AE resolved to ≤ Grade 1 or baseline:\n\n    1. ≥ Grade 3 ocular AE\n    2. Changes in liver function tests that met the criteria for Hy's Law (\\> 3× ULN of either ALT\u002FAST with concurrent \\> 2× ULN of total bilirubin (total and direct) and without alternate etiology)\n    3. ≥ Grade 3 neurologic toxicity\n    4. ≥ Grade 3 colitis\n    5. ≥ Grade 3 renal toxicity",{"count":68,"type":20},36,[70],"PHASE1","This is a multicenter, open-label, Phase I, first-in-human trial to characterize the safety and clinical activity of an antigen-specific CD8+ T-cell product in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers. Patients must have received at least one prior standard treatment regimen consisting of systemic immunotherapy and\u002For chemotherapy. The investigative agent is an autologous adoptive T-cell product derived from the patient's endogenous cytolytic T cells that are directed toward HPV-16 E6\u002FE7, HPV-18 E6\u002FE7 antigens, and a tumor-associated antigen (Survivin) by ex vivo exposure to an artificial antigen presenting cell to which HLA-A2 antigen-peptides have been fit within the pocket of an MHC class 1 molecule. Patients must express HLA-A\\*0201.",[73,74,75,76,77,78,79,80,81,82,41],"Oropharyngeal Cancer","Human Papilloma Virus","Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Cancer, Metastatic","Head and Neck Cancer Metastatic","HPV-Related Squamous Cell Carcinoma","HPV-Related Mucosal Head and Neck Squamous Cell Carcinoma","Relapsed Oropharyngeal SCC",[84,85,86,87,88,89,90,91],"relapsed or refractory HPV-related oropharyngeal cancer","human papilloma virus-related cancer","HPV-related head and neck cancer","HPV-related oropharyngeal cancer","cell therapy","adoptive cell therapy","NEXI-003","Head and neck cancer","NOT_YET_RECRUITING","2024-01-12",{"date":95,"type":51},"2024-01-16",{"date":97,"type":20},"2025-03-31",{"date":99,"type":20},"2027-08-25",{"name":101,"class":102},"NexImmune Inc.","INDUSTRY"]