[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma-of-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma-of-head-and-neck":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,41,0,25,[9,43,88,113,145,168,188,231,261,290,312,341,362,384,405,425,460,486,516,554,580,606,628,655,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100609794","phase-1-a-study-of-jnj-90301900-in-combination-with-chemoradiation-therapy-in-participants-with-locally-advanced-head-and-neck-squamous-cell-carcinoma-100609794",false,"NCT07219212","A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma","A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma","LUMIRAY","Inclusion criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx\n* Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines\n* A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines\n* Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1\n\nExclusion criteria:\n\n* Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site\n* Non-squamous histology\n* Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)\n* Ineligible to receive platinum-based chemotherapy\n* Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients","ALL","18 Years","74 Years",{"count":22,"type":23},45,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \\& throat).",[29],"Squamous Cell Carcinoma of Head and Neck","RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2026-01-26",{"date":38,"type":23},"2028-07-14",{"name":40,"class":41},"Johnson & Johnson Enterprise Innovation Inc.","INDUSTRY",17,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":66,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":51,"type":23},1109,[26,53],"PHASE2","The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[56,57,58,59,29,60,61,62,63,64,65],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Melanoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[67,56,68,69,70,57,71,58,72,73,59,74,75,29,60,61,62,63,64,65,76,77],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","2026-06-29",{"date":80,"type":34},"2026-06-30",{"date":82,"type":34},"2021-05-27",{"date":84,"type":23},"2031-08-31",{"name":86,"class":41},"Bristol-Myers Squibb",47,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":24,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100463615","phase-2-5-azacytidine-andor-nivolumab-in-resectable-hpv-associated-hnscc-100463615","NCT05317000","5-Azacytidine and\u002For Nivolumab in Resectable HPV-Associated HNSCC","A Window Trial of 5-Azacytidine or Nivolumab or Combination Nivolumab Plus 5-Azacytidine in Resectable HPV-Associated Head and Neck Squamous Cell Cancer","Inclusion Criteria:\n\n1. Patients with resectable squamous cell carcinoma of the oropharynx. Histologic or cytologic confirmation from either a biopsy\u002Faspirate of the oropharyngeal primary lesion and\u002For a regional lymph node is required.\n2. T1-T3, N0-N2, M0 stage by AJCC 8th edition for HPV-initiated oropharynx cancer.\n3. Resectability confirmed by a surgical co-investigator; evaluation may include operative endoscopy to discover second primaries and map tumor extent with biopsy\n4. In addition to diagnostic biopsies, biopsies in clinic or at the time of operative endoscopy are required to yield primary tumor for research purposes \\> 3mm cup forceps biopsies X 3. Prior biopsies for research obtained with informed consent for the Yale Biosample Repository Protocol are acceptable if they meet the volume requirements above.\n5. HPV-association confirmed by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells).\n6. Age \\> 18 years. 5-azacytidine and nivolumab are tolerated in the elderly and there is no upper age limit for patients with adequate performance status.\n7. ECOG performance status 0 or 1.\n8. Absolute neutrophil count (ANC) \\> 1500\u002Fmicroliter, absolute lymphocyte count (ALC) \\> 1000\u002Fmicroliter, hemoglobin \\> 9 g\u002Fdl, platelets \\> 100,000\u002Fmicroliter.\n9. AST and ALT \\\u003C 2.5 x upper limit of normal. Bilirubin \\\u003C 1.5 x upper limit of normal.\n10. Albumin \\> 3.0 g\u002Fdl.\n11. Creatinine \\\u003C 1.5 x upper limit of normal.\n12. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window.\n13. Willing and able to provide written informed consent. Informed consent is required prior to research-related activities, including biopsy. However, if written informed consent for participation in the biosample repository protocol has been obtained, tissue obtained under that consent can be used to meet eligibility criterion\n\nExclusion Criteria:\n\n1. Medical contraindication to transoral surgery.\n2. Full dose anticoagulation.\n3. Concomitant invasive malignancy, or malignancy within 2 years except for hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma or meningioma.\n4. Inability to give informed consent.\n5. Prior systemic therapy, radiation, or gross resection for the tumor under study.\n6. Women may not be pregnant or breast-feeding.\n7. Patients with active autoimmune disease, supraphysiologic systemic corticosteroid use within 7 days, and\u002For allergies\u002Fcontraindications to the study drugs are excluded.",{"count":96,"type":23},50,[53],"This study is being done because both 5-azacytidine and nivolumab can influence the immune system's response to HPV-associated head and neck cancer, and we wish to evaluate whether taking 5-azacytidine will make HPV-associated head and neck cancer more sensitive to treatment with nivolumab.\n\n5-Azacytidine (5-AZA) is a chemotherapy, and nivolumab is an immunotherapy. Both drugs are approved for use in the US by the Food and Drug Administration (FDA) for use in the treatment of different types of cancer, and nivolumab is approved for use in head and neck cancer that has previously been treated with chemotherapy. Because they are not approved to be used together in HPV-associated head and neck cancer, these drugs are considered experimental in this study. For this study, the drugs will be used either together or separately.",[29],[101],"HPV- Associated Head and Neck Squamous Cell Cancer","2026-06-08",{"date":104,"type":34},"2026-06-10",{"date":106,"type":34},"2023-03-23",{"date":108,"type":23},"2028-11-30",{"name":110,"class":111},"Barbara Burtness","OTHER",1,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":24,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100643672","phase-2-a-phase-ii-study-of-gv20-0251-in-combination-with-anti-pd-1-monoclonal-antibodies-in-patients-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100643672","NCT07623642","A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.\n2. Able and willing to participate in and comply with study procedures throughout the study.\n3. Age ≥ 18 and ≤ 80 years, any gender.\n4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.\n5. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.\n6. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.\n7. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR\u002FMSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).\n8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.\n9. If the subject has received prior anti-PD-1\u002FPD-L1 therapy, documented disease progression during treatment with anti-PD-1\u002FPD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors\u002Ftherapies) is required.\n10. Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.\n11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.\n12. Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is \\>3 years old, enrollment requires medical confirmation with the sponsor.\n13. ECOG performance status of 0-1 prior to the first dose on C1D1.\n14. Expected survival ≥ 24 weeks.\n15. No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n16. Adequate organ, Hepatic, and Coagulation function at screening.\n17. All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.\n18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.\n\nExclusion Criteria\n\n1. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase\u002Flipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.\n2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)\n3. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \\> 30 Gy within 6 months prior to C1D1.\n4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.\n5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy.\n6. History of gastrointestinal perforation and\u002For fistula within 6 months prior to consent; or active gastric\u002Fduodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.\n7. Clinically significant and\u002For uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \\> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.\n8. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and\u002For any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.\n9. Acute leukemia or chronic lymphocytic leukemia (CLL).\n10. QTcF \\> 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.\n11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.\n12. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1\n14. HIV infection.\n15. Active HBV or HCV infection\n16. Prior major organ transplantation\n17. Prior autologous or allogeneic bone marrow transplantation.\n18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.\n19. Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.\n20. Received a live or attenuated vaccine within 30 days prior to the first dose.\n21. Requires treatment with interferon-α or related\u002Fsimilar agents within 3 weeks prior to C1D1 or during the entire study period.\n22. Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume \\> 1.5 liters within 8 weeks prior to C1D1.\n23. Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.\n24. Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and\u002For sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.\n25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.","80 Years",{"count":122,"type":23},227,[53],"This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.",[126,65,127,29,128,129,130,131,132,133,134],"Uterine Cervical Neoplasms","Prostatic Neoplasms","Esophageal Squamous Cell Carcinoma","Cholangiocarcinoma","Gallbladder Neoplasms","Colorectal Neoplasms","Pancreatic Ductal Adenocarcinoma","Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma","NOT_YET_RECRUITING","2026-06-04",{"date":102,"type":34},{"date":139,"type":23},"2026-06-02",{"date":141,"type":23},"2029-08-15",{"name":143,"class":41},"GV20 Therapeutics",2,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":24,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100614192","phase-3-a-study-of-amivantamab-in-addition-to-standard-of-care-agents-soc-compared-with-soc-alone-in-participants-with-recurrentmetastatic-head-and-neck-cancer-100614192","NCT07276399","A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent\u002FMetastatic Head and Neck Cancer","A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma","OrigAMI-5","Inclusion criteria:\n\n* Be more than or equal to (\\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater)\n* Have histologically or cytologically confirmed recurrent\u002Fmetastatic (R\u002FM) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative\n* Be treatment-naive for systemic therapy in the R\u002FM setting\n* Have an ECOG performance status of 0 or 1\n* Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1\n\nExclusion criteria:\n\n* Have an uncontrolled illness\n* Have untreated brain metastases or history of known presence of leptomeningeal disease\n* Have a history of clinically significant cardiovascular disease\n* Inadequate organ or bone marrow function\n* Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase",{"count":154,"type":23},500,[156],"PHASE3","The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory\u002Fmetastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R\u002FM setting.",[29],{"date":160,"type":34},"2026-06-05",{"date":162,"type":34},"2025-12-03",{"date":164,"type":23},"2029-06-18",{"name":166,"class":41},"Janssen Research & Development, LLC",186,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":24,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},"100545682","phase-1-a-study-of-amivantamab-alone-or-in-addition-to-other-treatment-agents-in-participants-with-head-and-neck-cancer-100545682","NCT06385080","A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer","A Phase 1b\u002F2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma","OrigAMI-4","Inclusion Criteria:\n\n* Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent\u002Fmetastatic head and neck squamous cell carcinoma (R\u002FM HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L\u002FA) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease\n* Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1.\n* Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes \\[any grade\\], Grade less than or equal to \\[\\\u003C=\\]2 peripheral neuropathy and Grade \\\u003C=2 hypothyroidism stable on hormone replacement)\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test.\n\nParticipants should have: a) Hemoglobin \\>=9 grams per deciliter (g\u002FdL); b) Neutrophils \\>=1.5 x 10\\^3\u002Fmcg; c) Platelets \\>=100 x 10\\^3\u002Fmcg\n\nExclusion Criteria:\n\n* Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)\u002F pneumonitis\u002F pulmonary fibrosis, or where suspected ILD\u002Fpneumonitis\u002Fpulmonary fibrosis cannot be ruled out by imaging at screening\n* Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation\n* Participant with a history of clinically significant cardiovascular disease\n* Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days\n* Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment",{"count":177,"type":23},287,[26,53],"The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent\u002Fmetastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).",[29],{"date":160,"type":34},{"date":183,"type":34},"2024-04-22",{"date":185,"type":23},"2032-12-27",{"name":166,"class":41},56,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":24,"phases":197,"briefSummary":198,"conditions":199,"keywords":208,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100392410","phase-1-a-study-of-sigvotatug-vedotin-in-advanced-solid-tumors-100392410","NCT04389632","A Study of Sigvotatug Vedotin in Advanced Solid Tumors","A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors","Inclusion Criteria:\n\n* Disease indication\n\n  * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell cancer (HNSCC)\n    * Advanced HER2-negative breast cancer\n    * Esophageal squamous cell carcinoma (ESCC)\n    * Esophageal\u002FGastro-esophageal junction adenocarcinoma (EAC\u002FGEJ)\n    * Cutaneous squamous cell cancer (cSCC)\n    * Exocrine pancreatic adenocarcinoma\n    * Bladder cancer\n    * Cervical cancer\n    * Gastric cancer\n    * High grade serous ovarian cancer (HGSOC)\n  * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.\n  * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1\u002FPD-(L)1 inhibitor, if applicable and available.\n  * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \\[neo\\]adjuvant therapy is allowed).\n  * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.\n* Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:\n\n  * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.\n  * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease per the RECIST v1.1 at baseline\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,\n  * have no new or enlarging brain metastases, and\n  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.\n  * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6\n* Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts\n* Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.\n\n  * Routine antimicrobial prophylaxis is permitted\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses\n* Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).\n* History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening\n* Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \\\u003C50% predicted\n* Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":196,"type":23},1006,[26],"This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.\n\nThe study will have four parts.\n\n* Part A of the study will find out how much sigvotatug vedotin should be given to participants.\n* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.\n* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.\n* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.\n* In Parts C and D, participants will receive sigvotatug vedotin with either:\n\n  * Pembrolizumab or,\n  * Pembrolizumab and carboplatin, or\n  * Pembrolizumab and cisplatin.",[200,29,201,128,202,203,64,204,205,206,126,207],"Carcinoma, Non-Small Cell Lung","HER2 Negative Breast Neoplasms","Esophageal Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Cutaneous Squamous Cell Cancer","Exocrine Pancreatic Adenocarcinoma","Urinary Bladder Neoplasms","Stomach Neoplasms",[74,71,209,210,211,70,212,213,214,215,216,217,218,56,219,220],"cSCC","ESCC","EAC","HGSOC","Advanced HER2-Negative Breast Cancer","High Grade Serous Ovarian Cancer","Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Cancer","Esophageal Cancer","Bladder Cancer","Gastric Cancer","Seattle Genetics","2026-05-08",{"date":223,"type":34},"2026-05-11",{"date":225,"type":34},"2020-06-08",{"date":227,"type":23},"2029-03-22",{"name":229,"class":41},"Seagen, a wholly owned subsidiary of Pfizer",159,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":24,"phases":240,"briefSummary":241,"conditions":242,"keywords":248,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100545354","phase-1-a-phase-iii-trial-of-ucb4594-in-participants-with-advanced-cancer-100545354","NCT06380816","A Phase I\u002FII Trial of UCB4594 in Participants With Advanced Cancer","A Cancer Research UK Phase I\u002FII Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of UCB4594 Alone and in Combination With Anti-cancer Treatments in Participants With Advanced Malignancies","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product (IMP) administration and follow-up\n2. Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the participant. Module A (dose escalation): Tumour types which have shown high levels of human HLA-G expression (as reported in the literature): head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, renal cell cancer (clear cell only), oesophago-gastric cancer (excluding gastrointestinal stromal tumour), cervical cancer, ovarian cancer, pancreatic cancer. N.B. Participants with small cell type cancers on histology\u002Fcytology are excluded. Pre-treatment biopsies are mandatory for all participants. Paired biopsies will be mandatory for participants from doses of 30 mg and higher. Participants must have disease amenable to biopsy (excluding bone metastases) as deemed safe by the Investigator\n3. Measurable disease, according to RECIST v1.1\n4. Life expectancy of at least 12 weeks\n5. Eastern Cooperative Oncology Group performance status of 0 or 1\n6. Haematological and biochemical indices within defined ranges. These measurements should be performed to confirm the patient's eligibility to participate in the trial\n7. Aged 18 years or over at the time consent is given. Participants aged 16-17 years may be eligible for recruitment to the backfill cohorts in dose escalation once adequate safety and toxicity data have been established in participants aged 18 years or over. All relevant data will be reviewed and a decision on the inclusion of participants aged 16-17 years will be made by the Trial Management Group\n\nExclusion Criteria:\n\n1. Radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other IMPs during the previous 4 weeks or 5 half-lives (whichever is shorter) before the first dose of IMP\n2. Ongoing toxicity of previous treatments \\>CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone-replacement therapy (HRT)-managed endocrine disorders)\n3. Patients with rapidly progressing \u002F symptomatically deteriorating brain\u002Fleptomeningeal metastases\u002Funtreated brain metastases are excluded. Patients with previously treated brain metastases are eligible if they haven't had a seizure or a clinically significant change in neurological status or required steroids in the last 2 weeks\n4. Pregnant or breastfeeding female patients (or planning to breastfeed)\n5. Women of childbearing potential. However, those not already pregnant or breastfeeding (or who discontinue breastfeeding) and meet the following are eligible:\n\n   5.1. Have a negative serum pregnancy test within 7 days before enrolment and either:\n\n   5.2.1. Agree to a form of highly effective contraception plus a barrier method, or\n\n   5.2.2. Agree to sexual abstinence\n\n   Effective from the negative pregnancy test, throughout the trial and for 10 months after the last dose of UCB4594\n6. Male patients with partners of childbearing potential. However, patients who meet the following are eligible:\n\n   6.1. Agree to a barrier method of contraception or sexual abstinence\n\n   6.2. Males with pregnant or breastfeeding partners must use barrier method contraception to prevent exposure of the foetus or neonate\n\n   6.3. Non-vasectomised males must also ensure any partner of childbearing potential uses highly effective contraception or agrees to sexual abstinence\n\n   Effective from the date of the first dose of UCB4594, throughout the trial and for 5 months after the last dose of UCB4594 N.B. Males must refrain from donating sperm for the same period\n7. Surgery from which the patient has not yet recovered\n8. High medical risk because of non-malignant systemic disease, including serious or uncontrolled infection (requiring intravenous antibiotics) or unexplained fever \\>38°C within 2 weeks prior to the first dose of UCB4594\n9. Known to be serologically positive for hepatitis B virus, hepatitis C virus or human immunodeficiency virus\n10. Active or suspected autoimmune disease, or any history of autoimmune condition that required systemic corticosteroids or immunosuppressive agents. Patients who have ever had a transplant are excluded. This does not apply to patients with: vitiligo, alopecia, or type I diabetes mellitus, psoriasis not requiring chronic systemic immunosuppressive treatment within the past 2 years, stable autoimmune-mediated hypothyroidism on HRT, and Raynaud's syndrome\n11. Are being treated with escalating or supraphysiologic doses of corticosteroids or immunosuppressive agents. Participants with immunotherapy-related hypophysitis adequately treated with physiologic doses of steroids are not excluded. Use of topical, ophthalmic, inhaled, intermittent steroid injections, and intranasal corticosteroids are permitted\n12. Hypersensitivity to the ingredients\u002Fexcipients (including polysorbate 80) in UCB4594\n13. History of significant toxicities from treatment of immune checkpoint inhibitors (CPIs) that necessitated permanent discontinuation (Patients who started on combination CPI \\[e.g., ipilimumab\u002Fnivolumab\\] and had toxicity requiring discontinuation of one CPI \\[e.g., continued with nivolumab single agent\\] are not excluded)\n14. History of Grade ≥3 infusion-related reaction to monoclonal antibodies or similar drugs\n15. Prior treatment with HLA-G, immunoglobulin-like transcript (ILT)2 or ILT4-targeting drug\n16. Live, attenuated vaccine within 28 days prior to the first dose of IMP\n17. Increased risk due to tumour flare (e.g., an initial increase in tumour size that may lead to obstruction of airways, etc)\n18. Significant active pulmonary disease or condition at screening, including:\n\n    18.1. Lymphangitis carcinomatosa\n\n    18.2. History of interstitial lung disease or pulmonary fibrosis\n\n    18.3. History of pulmonary inflammatory disease\n19. Evidence of bleeding diathesis\n20. Significant cardiovascular disease, defined as a history of: congestive heart failure requiring therapy or left ventricular ejection fraction \\\u003C40%, unstable angina pectoris or myocardial infarction within 6 months prior to entry, or current poorly controlled angina (symptoms weekly or more), clinically significant cardiac arrhythmia within 6 months prior to entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block permitted), or myocarditis. Presence of symptomatic or severe valvular heart disease. Baseline QT interval corrected by Fridericia \\>450 msec for males and \\>470 msec for females on triplicate electrocardiogram is ineligible\n21. Participant in or plans to join another interventional trial\n22. Other current malignancies. Cancer survivors who have undergone potentially curative therapy for prior malignancy with no evidence of disease for 3+ years are eligible\n23. Any other condition that, in the Investigator's opinion, means the trial is not in the patient's best interest",{"count":239,"type":23},167,[26,53],"This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.\n\nThe four main aims of the clinical trial are to find out:\n\n1. The best dose of UCB4594 that can be given safely to participants in the trial.\n2. What the side effects of UCB4594 are and how they can be managed.\n3. What happens to UCB4594 inside the body and how it affects cancer cells.\n4. Whether UCB4594 can cause cancer to shrink.",[243,29,133,131,65,244,245,246,126,64,247],"Advanced Solid Tumours","Carcinoma, Renal Cell (Clear Cell Only)","Esophageal Neoplasms","Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors)","Pancreatic Neoplasms",[249,250,251],"HLA-G","Monoclonal Antibody","Cancer","2026-05-05",{"date":221,"type":34},{"date":255,"type":34},"2024-07-09",{"date":257,"type":23},"2029-11",{"name":259,"class":111},"Cancer Research UK",4,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":24,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":286,"leadSponsor":288,"locationsCount":112},"100625194","phase-2-5-fluorouracil-response-and-optimization-study-the-frost-trial-100625194","NCT07419464","5-Fluorouracil Response and Optimization STudy (The FROST Trial)","The 5-Fluorouracil Response and Optimization STudy (The FROST Trial): A Randomized Phase II Trial of Two Dosage Regimens (2D-Q2W vs 4D-Q3W) of 5-Fluorouracil (5-FU) in Patients With Platinum and PD-1 Inhibitor Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed:\n\n  * RM-HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx, OR\n  * p16+ (HPV-related) level 2-3 neck node and unknown primary site, OR\n  * Second primary HNSCC in a previously radiated field not amenable to curative-intent surgery and\u002For re-radiation.\n* Measurable disease per RECIST 1.1.\n* Previously treated with platinum-based chemotherapy, RM disease within 6 months of definitive cisplatin + radiation therapy (DCisRT) or post-operative adjuvant cisplatin + radiation therapy (POACisRT) OR progressive disease on or after or intolerance to platinum agent given for RM disease.\n* Previously treated with PD-1 inhibitor, RM disease within 6 months of PD-1 inhibitor given as part of curative-intent therapy OR progressive disease on or after PD-1 inhibitor given for RM disease OR intolerance to prior PD-1 inhibitor in the curative or metastatic setting.\n* At least 18 years of age\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease ≤ 3 x IULN)\n  * AST(SGOT)\u002FALT(SGPT)\u002FAlkaline Phosphatase (ALP) ≤ 3.0 x IULN. For subjects with documented bone metastasis, ALP ≤ 5.0 x IULN.\n  * Serum creatinine \\\u003C3 mg\u002FdL or creatinine clearance \\> 30 mL\u002Fmin by Cockcroft- Gault.\n* The effects of 5-FU on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after last dose of 5-FU\n* Recovery to baseline or ≤ grade 1 from AEs due to prior therapy, unless AEs are clinically nonsignificant and\u002For stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ grade 2 hypomagnesemia, or ≤ grade 2 neuropathy are permitted.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior 5-FU given to treat RM-HNSCC.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving any other investigational agents.\n* RM or incurable second primary SCC of cutaneous, nasopharynx, paranasal\u002Fnasal\u002Fsinus origin.\n* DPYD deficiency (poor or intermediate metabolizer) as determined by next generation sequencing through blood or saliva (results of historical testing are accepted).\n* Severe hepatic impairment (Child-Pugh C) or history of hepatitis B or C.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-FU or other agents used in the study.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 14 days of study registration.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.",{"count":269,"type":23},46,[53],"This randomized phase II trial will characterize the efficacy, adverse event (AE) profile, and safety of two regimens of 5-FU given as 2L+ treatment to patients with RM-HNSCC. Eligible patients for this trial will have previously received platinum and PD-1 inhibitor therapy. The experimental regimen (Arm 1) will comprise the two days every two weeks (2D-Q2W) regimen of 5-FU. The standard regimen (Arm 2) will consist of the four days every three weeks (4D-Q3W) regimen of 5-FU. The primary hypotheses is that each regimen of 5-FU will result in an ORR of 10% of greater assessed by RECIST v1.1 criteria. The study will also describe treatment-related AEs assessed by CTCAE v5.0, dose interruptions, discontinuations, and modifications in each regimen.",[29,273,274],"Metastatic Squamous Cell Carcinoma","Recurrent Squamous Cell Carcinoma of the Head and Neck",[276,71,277,278,279,280,281],"5-FU","RM-HNSCC","Oral cavity","Oropharynx","Larynx","Hypopharynx","2026-04-21",{"date":284,"type":34},"2026-04-27",{"date":282,"type":34},{"date":287,"type":23},"2031-07-31",{"name":289,"class":111},"Washington University School of Medicine",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":299,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":112},"100634953","a-study-investigating-the-efficacy-and-safety-of-the-combination-of-iparomlimab-and-tuvonralimab-with-or-without-chemotherapy-in-second-line-and-subsequent-treatments-for-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100634953","NCT07546383","A Study Investigating the Efficacy and Safety of the Combination of Iparomlimab and Tuvonralimab With or Without Chemotherapy in Second-line and Subsequent Treatments for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Sign a written informed consent form before any trial-related procedures are performed；\n2. Ages 18 to 75, regardless of gender；\n3. ECOG performance status of 0-2；\n4. Pathologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck, including the oropharynx, oral cavity, hypopharynx, or larynx；\n5. Has received systemic therapy for recurrent or metastatic HNSCC；\n6. Expected survival time \\> 3 months；\n7. At least one measurable lesion according to the RECIST 1.1 criteria\n8. All acute toxicities resulting from prior anticancer therapy must have resolved to Grade 0-1 (according to NCI CTCAE Version 5.0) or to a level acceptable under the inclusion\u002Fexclusion criteria；\n9. Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within the normal range. (These levels may be controlled by thyroid replacement therapy.) Asymptomatic subjects with abnormal T3, free T3, or free T4 levels may be enrolled；\n10. Patients must have adequate organ and bone marrow function, and laboratory test results within 7 days prior to grouping must meet the following requirements (conditions must not be met by administering any blood components, cell growth factors, albumin, or other corrective medications within 14 days prior to obtaining the laboratory tests), as follows: 1) Complete blood count (CBC): Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count (PLT) ≥ 75 × 10⁹\u002FL (≥ 50 × 10⁹\u002FL for patients with cirrhosis or splenomegaly); Hemoglobin (HGB) ≥ 90 g\u002FL; 2) Liver function: Serum total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5×ULN; 3) Renal function: Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (CCr) ≥ 50 mL\u002Fmin (Cockcroft-Gault formula); Qualitative urine protein ≤ 1+; if qualitative urine protein is ≥ 2+, a 24-hour urine protein quantification test must be performed; if the 24-hour urine protein quantification is \\\u003C 1 g, it is acceptable; Coagulation function: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 2 times the upper limit of normal (ULN).\n\nExclusion Criteria:\n\n1.A confirmed history of other types of cancer unrelated to the target cancer in this study (head and neck squamous cell carcinoma)； 2.Subjects with central nervous system metastases or brain metastases； 3.Patients with acute or chronic active hepatitis B or C; those with hepatitis B virus (HBV) DNA \\> 1,000 IU\u002FmL who have failed antiviral therapy; those with hepatitis C virus (HCV) RNA \\> 10³ copies\u002FmL who have been assessed as unsuitable for immunotherapy; and those who are simultaneously positive for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies； 4.Any life-threatening bleeding episode within the past 3 months, including those requiring blood transfusion, surgery, or local treatment, or ongoing medication； 5.A history of arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic event. Implantable venous access ports or catheter-related thrombosis, or superficial vein thrombosis, unless the thrombus is stable following conventional anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin (e.g., enoxaparin 40 mg\u002Fday) is permitted； 6.Use of aspirin (\\> 325 mg\u002Fday) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, for 10 consecutive days within 2 weeks prior to the first dose； 7.Symptomatic congestive heart failure (New York Heart Association Class II-IV). Symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or a corrected QTc \\> 500 ms on screening (calculated using the Fridericia formula)； 8.A severe bleeding tendency or coagulation disorder, or currently undergoing thrombolytic therapy； 9.A history of gastrointestinal perforation and\u002For fistula within the past 6 months; a history of intestinal obstruction (including partial intestinal obstruction requiring parenteral nutrition); extensive intestinal resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea); Crohn's disease; ulcerative colitis; or long-term chronic diarrhea； 10.A history of or current pulmonary conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impairment of lung function； 11.Known history of alcohol abuse, psychotropic substance abuse, or drug use； 12.A history of specific neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc； 13.Active pulmonary tuberculosis (TB), individuals currently undergoing antituberculosis treatment, or those who received antituberculosis treatment within one year prior to the first dose； 14.Individuals infected with human immunodeficiency virus (HIV) (HIV-1\u002F2 antibody-positive) and individuals with known syphilis； 15.Active severe infections or infections that are not well clinically controlled. Severe infections within 4 weeks prior to the first dose, including but not limited to hospitalization due to complications from infection, bacteremia, or severe pneumonia； 16.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is permitted. Known history of primary immunodeficiency. Patients who are only positive for autoimmune antibodies must be evaluated by the investigator to determine whether an autoimmune disease is present； 17.Use of immunosuppressive drugs within 4 weeks prior to the first dose, excluding topical corticosteroids administered via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses (i.e., no more than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids); temporary use of corticosteroids to treat dyspnea associated with conditions such as asthma or chronic obstructive pulmonary disease is permitted； 18.Within 4 weeks prior to the first dose, or if the patient is scheduled to receive an attenuated live vaccine during the study； 19.Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose, or unhealed wounds, ulcers, or fractures. Tissue biopsy or other minor surgical procedures within 7 days prior to the first dose, excluding venipuncture or catheter placement for the purpose of intravenous infusion； 20.Uncontrolled or uncorrectable metabolic disorders, other non-malignant organ diseases, systemic diseases, or secondary reactions to cancer, which may result in a higher medical risk and\u002For uncertainty regarding survival prognosis； 21.A diagnosis of another malignancy within 5 years prior to the first dose, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been curatively resected. If another malignancy or hepatocellular carcinoma was diagnosed more than 5 years prior to dosing, a pathological or cytological diagnosis of the recurrent or metastatic lesions is required； 22.A history of severe allergic reactions to study drug components (such as the epa-loritovireli combination antibody, platinum agents, docetaxel, or paclitaxel)； 23.Has received treatment in another clinical trial or is currently participating in another clinical study within 4 weeks prior to the first dose； 24.Pregnant or breastfeeding patients； 25.Other acute or chronic medical conditions, psychiatric disorders, or abnormal laboratory test results that may lead to the following: increased risks associated with study participation or administration of the study drug, or interference with the interpretation of study results; and, in the investigator's judgment, render the patient ineligible for participation in this study.\n\n.","75 Years",{"count":298,"type":23},32,[300],"NA","This is a single-arm, open-label, phase II study to evaluate the efficacy and safety of the combination of the antibodies iparomlimab and tuvonralimab, administered with or without chemotherapy, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R\u002FM HNSCC) who have progressed after receiving at least one line of systemic therapy.\n\nThe study includes a safety run-in phase with approximately three patients, which may be expanded to six if a dose-limiting toxicity is observed. Patients are then assigned to either combination antibody monotherapy or combination antibody plus chemotherapy, based on PD-L1 combined positive score (CPS), symptom burden, disease characteristics and patient preference.\n\nMonotherapy involves iparomlimab and tuvonralimab (5 mg\u002Fkg on day 1, every 3 weeks).\n\nCombination therapy involves the same antibody regimen plus up to six cycles of platinum (carboplatin at an area under the curve (AUC) of 5 or cisplatin at 75 mg\u002Fm²) plus docetaxel (75 mg\u002Fm²) or paclitaxel (135-175 mg\u002Fm²), followed by antibody monotherapy maintenance.\n\nThe primary objective is to assess the objective response rate (ORR) according to RECIST 1.1. The secondary objectives are to evaluate the disease control rate (DCR), the 6-month progression-free survival (PFS) rate, the 6-month overall survival (OS) rate and the safety profile. Exploratory objectives include the association of tumour biomarkers (PD-L1 expression and tumour mutation burden) with efficacy.",[29],"2026-04-16",{"date":305,"type":34},"2026-04-22",{"date":307,"type":23},"2026-04-13",{"date":309,"type":23},"2028-12-31",{"name":311,"class":111},"The Second Affiliated Hospital of Hainan Medical University",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":24,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":144},"100627930","phase-1-neoadjuvant-cadi-05-in-combination-with-pembrolizumab-for-surgically-resectable-locally-advanced-head-and-neck-squamous-cell-carcinomas-100627930","NCT07455032","Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas","Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (LA-HNSCC)","Inclusion Criteria:\n\n* Histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx\u002Fhypopharynx\u002Foral cavity primaries (AJCC 8th edition) with programmed death ligand -1 (PD-L1) combined positive score (CPS) ≥ 1 (as determined by any clinical pathology laboratory) Patients must be planned for definitive surgical resection as determined by a multidisciplinary tumor board or equivalent multidisciplinary determination.\n* Patients with recurrence or metachronous primary SCC of head and neck origins with previous history of surgery\u002Fradio (chemo)-therapy are allowed if definitive surgery is planned and if pembrolizumab is planned as a neoadjuvant strategy. Patients should have recovered from the effects of radiation or other prior treatments: AE\u002Fsequelae should resolve to ≤ grade 2 (no minimum recovery period required).\n* Patients must have an archival biopsy from the primary tumor site or regional lymph nodal metastasis with adequate tumor tissue as judged by study PI. There should not be any oncological treatments between the pre-CADI-05 biopsy and W1 Pembrolizumab\u002FCADI-05 treatment initiation. Note: If pretreatment material is a cytology specimen and deemed unsuitable for correlative testing, a core biopsy will be strongly recommended.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Patients must consent to provide either archival (if available \\& sufficient) or fresh pre-treatment tissue biopsy for research, and consent for the use of their residual post-operative tissue for research.\n* Adequate bone marrow, liver and kidney function as demonstrated by:\n\n  * Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL\n  * Hgb \\> 7 g\u002FdL (use of transfusion to reach this threshold prior to study initiation is acceptable)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.5\n\n    * upper limit of normal (ULN)\n  * Total serum bilirubin ≤1.5 ULN\n  * Patients with suspected Gilbert's disease may enroll provided that total bilirubin must be \\\u003C 3 mg\u002FdL\n  * Creatinine clearance (CrCL) \\> 30 mL\u002Fmin as measured via Cockcroft-Gault\n* Female patients must be surgically sterile or be postmenopausal or must use highly effective contraception while receiving trial treatment.\n* Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.\n\nExclusion Criteria:\n\n* Patients who are considered candidates for organ preservation through upfront concurrent chemoradiation therapy will be excluded from this study.\n* Receiving any investigational agent currently or within 28 days of first dose of CADI-05.\n* Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the subject or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis, Crohn's disease\\]; diverticulitis with the exception of a prior episode that has resolved or diverticulosis; celiac disease; irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \\[granulomatosis with polyangiitis\\]; myasthenia gravis; rheumatoid arthritis; hypophysitis, uveitis; etc.) within the past 2 years prior to the start of treatment. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.\n* Other prior or concomitant malignancies with the exception of:\n\n  * Non-melanoma skin cancer\n  * In-situ malignancy or any other malignancy that does not affect the primary management of the HNSCC under consideration including delivery of neoadjuvant pembrolizumab and definitive surgery plan.\n  * Low-risk prostate cancer after curative therapy\n  * Other cancer for which the subject has been disease free for ≥ 2 years before the first dose of study drug and of low potential risk for recurrence.\n* Any concurrent chemotherapy, investigational treatment, biologic or hormonal therapy for cancer treatment except adjuvant intent hormonal therapy for definitively treated breast or prostate cancer that has not recurred in last 2 years. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.\n* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of CADI-05. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiological doses not to exceed 10mg\u002Fday of prednisone or equivalent. \\[NOTE: If systemic corticosteroids are part of the treatment regimen for the indication under study, the systemic corticosteroid is permitted\\].\n* Uncontrolled human immunodeficiency virus (HIV) infection with CD4+ T \\\u003C 200 cells\u002Fmm3.\n* Untreated or uncontrolled hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV). Patients with hepatitis B receiving treatment with anti- HBV therapy and having undetectable virus titers will be included.\n* History of primary immunodeficiency.\n* History of organ transplant.\n* Pregnant or breastfeeding. Refer to section 4.4 for further detail.",{"count":320,"type":23},22,[26],"The goal of this clinical trial is to learn if drug CADI-05, when used together with pembrolizumab (an FDA approved immunotherapy), can help treat locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults. It will also learn about the safety of drug CADI-05. The main questions it aims to answer are:\n\n* Does using CADI-05 together with pembrolizumab help the immune system fight cancer better and lead to better results for patients?\n* What side effects or health problems might happen when people receive these two treatments?\n\nParticipants will:\n\n* Get pembrolizumab by IV (through a vein) once on day 1 of week 1 and again day 1 of week 4. This is standard of care treatment.\n* Get CADI-05 as a small injection into the skin once a week for 5 weeks. This is the experimental (research) treatment.\n* Visit the clinic every week for treatments, checkups and tests for 5 weeks.\n* Have surgery between week 6 and week 7.\n* Return to the clinic once for a follow-up visit about 30 days after surgery.",[29],[325,326,327,328,329,330,331],"Squamous cell Carcinoma of Head and Neck","CADI-05","Pembrolizumab","Immunotherapy","Neoadjuvant","Surgery","Locally advanced","2026-04-10",{"date":334,"type":34},"2026-04-15",{"date":336,"type":34},"2026-04-08",{"date":338,"type":23},"2028-01-31",{"name":340,"class":111},"Fox Chase Cancer Center",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":24,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":359,"locationsCount":361},"100512475","phase-2-candida-therapeutic-vaccine-in-head-and-neck-cancer-patients-to-reduce-recurrence-100512475","NCT05952934","Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence","A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence","Inclusion Criteria:\n\n* Able to provide informed consent\n* Male or female 18 years of age or older\n* Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and\u002For radiation and\u002For chemotherapy and\u002For immunotherapy) within the 120 days prior to the screening visit\n* No Evidence of Disease (NED) based on clinical and radiographic evaluations\n* Willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Positive urine pregnancy test for women of childbearing potential\n* Being pregnant or attempting to be pregnant with the period of study participation\n* Women who are breast feeding or plan to breast feed within the period of study participation\n* Patients who are allergic to Candin®\n* If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study","100 Years",{"count":350,"type":23},100,[53],"This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 80 subjects are eligible for injection.",[29],"2026-04-02",{"date":336,"type":34},{"date":357,"type":34},"2024-02-12",{"date":287,"type":23},{"name":360,"class":111},"University of Arkansas",6,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":24,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":112},"100632085","phase-3-cetuximab-combined-with-pembrolizumab-or-finotonlimab-and-chemotherapy-in-rm-hnscc-100632085","NCT07509099","Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R\u002FM HNSCC","Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R\u002FM HNSCC: an Open-label, Randomized, Prospective, Multicenter Phase III Trial","Inclusion Criteria:\n\n1. Age 18-70 years;\n2. ECOG Performance Status 0 or 1;\n3. Histologically confirmed diagnosis of head and neck squamous cell carcinoma;\n4. Subjects with distant metastasis or local recurrence not suitable for curative treatment; local recurrence patients must have previously received radiotherapy (postoperative or radical);\n5. No prior systemic chemotherapy; subjects who have ceased chemotherapy for locally advanced disease as part of multidisciplinary treatment for more than 6 months may be enrolled;\n6. At least one measurable lesion available for evaluation by enhanced CT or MRI according to RECIST 1.1;\n7. Adequate organ function:\n8. Estimated survival greater than 3 months;\n9. Voluntary signing of informed consent form, with good compliance expected, and ability to follow up as required by the protocol.\n\nExclusion Criteria:\n\n1. Nasopharyngeal carcinoma；\n2. Known allergic reaction against any of the components of the trial treatment;\n3. a. Previous treatment with immune checkpoint inhibitors (ICIs) (Prior receipt of ICIs is allowed if they were given as part of curative-intent neoadjuvant therapy, with more than 6 months between the last dose and disease recurrence, or as adjuvant ICI monotherapy that achieved disease control for over 6 months); b. Previous treatment with cetuximab (Prior receipt of cetuximab is allowed if they were given as part of curative-intent therapy, with more than 6 months between the last dose and disease recurrence); c．Previous treatment with chemotherapy (Prior receipt of chemotherapy is allowed if they were given as part of curative-intent neoadjuvant and adjuvant therapy, with more than 6 months between the last dose and disease recurrence) The end date of the therapies mentioned above is the date of the last administration.\n4. Clinically significant heart disease, including severe heart failure: NYHA heart failure class III\\~IV, ischemic heart disease (e.g., myocardial infarction or angina), acute myocardial infarction or congestive heart failure or QTc interval greater than 500 ms within the last 6 months;\n5. Undergoing or expected to undergo secondary or higher surgeries within three weeks prior to the first dose;\n6. Autoimmune diseases requiring treatment or a history of syndromes requiring systemic use of corticosteroids or immunosuppressants, such as pituitary inflammation, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.;\n7. Other serious uncontrolled concomitant diseases affecting protocol compliance or result interfere, including uncontrolled diabetes or pulmonary diseases (interstitial pneumonia, obstructive lung disease, and symptomatic bronchospasm history);\n8. Known active central nervous system metastasis and\u002For leptomeningeal disease; Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging (using the identical imaging modality for each assessment, either MRI or CT scan) for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n9. Hepatitis B (HBV) (HBsAg positive and HBV-DNA≥ 103 IU\u002Fml), hepatitis C (HCV) infection (HCV antibody positive and detectable HCV-RNA); and other acquired or congenital immunodeficiency diseases, including but not limited to HIV infection;\n10. Pregnant or breastfeeding women, or women planning to conceive during treatment and within 6 months after the last dose of study medication. Fertile women and sexually active men unwilling to use highly effective contraception during the study and for 6 months afterward.\n11. Severe active infections;\n12. Severe neurological or psychiatric history, including dementia or epilepsy;\n13. Drug abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the trial or the assessment of results;\n14. Other reasons deemed unsuitable for enrollment by the investigator.","70 Years",{"count":371,"type":23},316,[156],"This is an open-label, randomized, prospective, multicenter phase III trial to evaluate the efficacy and safety of the combination therapy of cetuximab with either pembrolizumab or finotonlimab, alongside chemotherapy, as a first-line treatment, compared with pembrolizumab or finotonlimab with chemotherapy for R\u002FM HNSCC.",[29],"2026-03-28",{"date":377,"type":34},"2026-04-03",{"date":379,"type":23},"2026-04-01",{"date":381,"type":23},"2030-09-30",{"name":383,"class":111},"Ji Dongmei",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":112},"100553539","hn-bio-02-a-phase-ii-randomized-study-of-the-effects-of-delayed-elective-radiotherapy-on-head-and-neck-mri-and-immune-response-biomarkers-100553539","NCT06487403","HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers","HN-Bio 02","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years\n* Histologically proven Head and Neck Squamous Cell carcinoma\n* Primary or nodal disease \\> 3cm for biomarker imaging\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Planned for curative surgery or (chemo)radiotherapy\n* Willingness to undergo repeat MRI imaging\n* Able to receive and understand verbal and written information regarding study and able to -give written informed consent\n* Adequate renal function: Calculated creatinine clearance \\>\u002F= 30ml\u002Fmin\n* Be able to lie comfortably on back for 1 hour\n\nExclusion Criteria:\n\n* As judged by investigator evidence of systemic disease that makes unsuitable for study\n* Contra-indication for serial MRI scans\n* Previous solid tumor treated within last 5 years\n* Pregnancy\n* History of gadolinium contrast allergy\n* Non-reversible clotting abnormality",{"count":392,"type":23},40,[300],"This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative therapy. This research is part 2 of the HN-BIO study.",[29],"2026-03-03",{"date":398,"type":34},"2026-03-04",{"date":400,"type":34},"2025-04-17",{"date":402,"type":23},"2028-08-01",{"name":404,"class":111},"University Health Network, Toronto",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":24,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":112},"100522681","a-study-of-head-and-neck-mri-and-tumor-microenvironment-biomarkers-100522681","NCT06085781","A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers","HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers","HN-BIO","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years\n* Histologically proven Head and Neck Squamous Cell carcinoma\n* Primary or nodal disease \\> 3cm for biomarker imaging\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Planned for curative surgery or (chemo)radiotherapy\n* Willingness to undergo repeat MRI imaging\n* Able to receive and understand verbal and written information regarding study and able to give written informed consent\n* Adequate renal function: Calculated creatinine clearance \\>\u002F= 30ml\u002Fmin\n* Be able to lie comfortably on back for 1 hour\n\nExclusion Criteria:\n\n* As judged by investigator evidence of systemic disease that makes unsuitable for study\n* Contra-indication for serial MRI scans\n* Previous solid tumor treated within last 5 years\n* Pregnancy\n* History of gadolinium contrast allergy\n* Non-reversible clotting abnormality",{"count":414,"type":23},60,[300],"The purpose of this study is to explore biomarker development in patients with newly diagnosed Head and neck squamous cell carcinoma (HNSCC) receiving curative therapy.",[29],{"date":419,"type":34},"2026-03-05",{"date":421,"type":34},"2024-01-29",{"date":423,"type":23},"2027-01-15",{"name":404,"class":111},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":447,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100597801","phase-2-a-study-of-sacituzumab-govitecan-in-combination-with-cetuximab-in-people-with-head-and-neck-squamous-cell-cancer-hnscc-100597801","NCT07063212","A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)","A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion.\n\n  * Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and\u002For radiation based approaches\n  * Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial\n  * HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I.\n  * Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if they are measurable and progression has been demonstrated in these lesions.\n* Male or female patients 18 years of age or older on the day of consent.\n* ECOG Performance Status of 0 to 1.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  o Serum creatinine \\\u003C 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr)\n\n  ≥ 30 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN.\n  * AST and ALT \\\u003C 2.5 x the upper limit of normal\n  * Albumin ≥ 3 g\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n* Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.\n* Female patients are eligible to participate if they are not pregnant, not breastfeeding and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential\n  * A woman of childbearing potential who agrees to use highly effective contraception from signing of the ICF through six months after the last study treatment administration.\n\nNotes:\n\ni. Female of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year. ii. Highly effective contraception methods include:\n\n* Total abstinence\n* Male or female sterilization\n* Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3):\n\n  * Category 1: Use of oral, injected, or implanted hormonal methods of contraception.\n  * Category 2: Placement of an intrauterine device or intrauterine system.\n  * Category 3: Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * A female participant who is of childbearing potential must have a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test within 72 hours prior to the first administration of study treatment or be surgically\u002Fbiologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal. Note: Postmenopausal females are defined as those who are:\n* Age \\> 50 years with amenorrhea for ≥ 12 months.\n* Age ≤ 50 years with six months of spontaneous amenorrhea and follicle stimulating hormone level within postmenopausal range (\\> 40 mIU\u002FmL).\n\n  * Male patients must agree to use contraception and refrain from sperm and egg donation from the time period between signing of the ICF and through five months after the last dose of study drug\n  * The subject must provide voluntary study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent\u002Fmetastatic setting.\n\n  o Ambiguity regarding lines of treatment a patient has received will be subject to PI review and approval.\n* Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and\u002For consultation with allergy\u002Fimmunology.\n* Patients who have previously received topoisomerase I inhibitors for HNSCC\n* Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome\n* Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.\n* Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.\n\n  * Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this criterion and may qualify for the study.\n  * Note: If subjects underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study drug.\n  * Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis which must be recovered, \\\u003C Grade 1) related to immunotherapy and\u002For radiation treatment that are long lasting, but stable on treatment and not requiring agents that are excluded by this protocol may qualify for the study.\n* Patients with simultaneous primary cancers aside from HNSCC will be excluded unless otherwise approved by PI.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI\n* Severe, active co-morbidity defined as the following:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute infection requiring intravenous therapy at the time of registration\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defect\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain metastases and are taking ≤ 20 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.\n* Known acquired immunodeficiency syndrome due to untreated\u002Fpoorly controlled human immunodeficiency virus. Other diagnosed immunodeficiency syndromes or disorders will require the review and approval of the site PI.\n* Positive test for hepatitis B surface antigen (HBsAG) or hepatitis C virus antibody (anti-HCV), indicating acute or chronic infection. Patients who test positive for anti-HCV but negative for HCV ribonucleic acid (RNA) are permitted to enroll.\n* Herbal remedies known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise between the PI and treating investigator.\n* Female patients who are pregnant, breastfeeding, or plan on becoming pregnant during the study.",{"count":392,"type":23},[53],"The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and\u002For metastatic head and neck squamous cell cancer (HNSCC).",[29,436,437,438,439,440,441,442,443,444,445,446],"Sinus Cancer","Nasal Cavity Cancer","Oral Cavity Cancer","Oropharynx Cancer","Hypopharynx Cancer","Larynx Cancer","Oral Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[29,436,437,438,439,440,441,442,443,444,445,446,448,449,450],"Sacituzumab Govitecan","25-094","Memorial Sloan Kettering Cancer Center","2026-02-17",{"date":453,"type":34},"2026-02-19",{"date":455,"type":34},"2025-07-02",{"date":457,"type":23},"2028-01-02",{"name":450,"class":111},7,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":24,"phases":469,"briefSummary":470,"conditions":471,"keywords":472,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"100558958","phase-2-reduction-in-the-number-of-chemotherapy-cycles-in-combination-with-pembrolizumab-in-first-line-treatment-of-pd-l1-positive-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinomas-100558958","NCT06557889","Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas","REDUCE","Inclusion Criteria:\n\n1. Age ≥ 18 years old on the day of signing the informed consent.\n2. Diagnosis of histologically proven recurrent or metastatic squamous cell carcinoma of the head and neck not accessible to treatment with curative intent.\n3. Patients must not have received previous systemic therapy administered in the context of recurrent or metastatic disease.\n4. If the patient received chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease, it must have ended at least 6 months before signing the consent.\n5. Eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx and larynx. Subjects cannot have a primary tumor site (any histology) in the nasopharynx, sinuses, nasal cavity, salivary glands, or skin.\n6. Documented Combined Positive Score (CPS) PD-L1 ≥ 1 (determined according to local practices in each center) Note: the CPS score can be performed on a new biopsy or on an archived tumor specimen, without date limitation.\n7. Have measurable disease on CT-scan (or on MRI of the neck if it provides a better measurement of the primary tumor according to standard practice and the investigator judgement) according to RECIST 1.1 as determined by the investigator. Tumor lesions located in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Note : In case of neck MRI assessment, the chest, abdominal, and pelvic CT scan must be performed in addition to assess potential metastases.\n8. Have a performance status of 0 or 1 on the ECOG performance scale.\n9. Demonstrate adequate organ function as defined in the protocol.\n10. Have HPV status test results for oropharyngeal cancers defined as a p16 immunohistochemical (IHC) test (determined according to local practices in each center).\n\n    Note: Cancers of the oral cavity, hypopharynx, and larynx are not required to perform HPV testing by p16 IHC because, by convention, these tumor locations are assumed to be HPV negative.\n11. Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.\n12. Female subjects of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 4 months for pembrolizumab, 6 months for carboplatin and 5-fluorouracil, and 7,5 months for cisplatin after the last dose of study treatment respectively for each molecule. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months.\n\n    Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n13. Male subjects must agree to use at least one method of contraception for the duration of the study and until 180 days after the last dose of study treatment.\n\n    Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n14. Signed written informed consent\n15. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n16. Patient affiliated to a Social Health Insurance in France\n\nExclusion Criteria:\n\n1. Has a disease accessible to local treatment with curative intent.\n2. Has a progressive disease within six months following the end of primary treatment with curative intent, if this treatment included systemic treatment with platinum salt.\n3. Has a complete DPD enzyme deficiency, suggested by an uracilemia \\> or equal to 150 ng\u002FmL.\n4. Has a contraindication to full dose use of a platinum salt, 5-Fluorouracil, or pembrolizumab, in the opinion of the investigator (dose reductions in cycle 1 are not authorized, except in the case of adaptation of the 5-FU due to partial DPD deficiency); the investigator must refer to the SmPC of the products used in this trial (carboplatin, cisplatin, 5-fluorouracil, and pembrolizumab).\n5. The patient must not have received antibiotics within 14 days before inclusion in the trial.\n6. Received radiotherapy (or other non-systemic therapy) within 2 weeks prior to inclusion.\n7. Subject has not fully recovered (i.e. ≤ Grade 1) from adverse events due to previously administered treatment.\n\n   Note: Subjects with neuropathy ≤ Grade 2, alopecia ≤ Grade 2, or laboratory values not exceeding the limits in Table 1 (See the protocol) are an exception to this criterion and may be eligible for the study Note: If the subject has undergone major surgery, they must have adequately recovered from the toxicity and\u002For complications of the procedure before starting treatment.\n8. Currently participating in and receiving study treatment, or has participated in a study of an investigational agent, or used an investigational device, within 4 weeks prior to the first dose of treatment.\n\n   Note: Participation in the follow-up phase of a previous study is permitted (if the patient is no longer receiving treatment in that study).\n9. Has a life expectancy of less than 3 months and\u002For has a rapidly progressing illness (eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator.\n10. Has a diagnosis of immunodeficiency or is receiving systemic corticosteroid therapy \\> 10 mg\u002Fday of prednisone equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. The use of corticosteroids as premedication for allergic reactions (e.g., IV contrast) or as prophylactic management of adverse events related to protocol-specified chemotherapies is permitted.\n11. Has a diagnosis of a second cancer diagnosed and\u002For treated within 5 years preceding inclusion, with the exception of: curatively resected basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer.\n\n    Note: The 5 year period does not apply to the cancer for which the subject is enrolled in the trial.\n12. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\n    Note: Subjects with previously treated brain metastases may participate provided they have been stable (without evidence of progression by imaging using the same imaging modality for each assessment, either MRI or CT) for at least 4 weeks prior to the first dose of trial treatment, and without neurological symptoms, have no signs of new or progressing brain metastases, and are not using steroids \\> 10mg\u002Fday of prednisone equivalent for at least 7 days before study inclusion. This exception does not include carcinomatous meningitis which is excluded regardless of the clinical situation.\n13. Active autoimmune disease that has required systemic treatment within the past 2 years (i.e. with the use of corticosteroids or immunosuppressive drugs). Replacement therapy (for example: thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n14. Has undergone solid tissue\u002Forgan allograft or hematopoietic allograft.\n15. Has a history of or has non-infectious pneumonia requiring corticosteroids.\n16. Has an active infection requiring systemic anti-infectious treatment.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that could interfere with the results of the trial or with the subject's participation throughout the duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.\n18. Is pregnant or breastfeeding, or expects to conceive or father children during the planned duration of the trial, beginning the screening visit through and until 4 months for pembrolizumab, 6 months for carboplatin and 5-fluorouracil, and 7,5 months for cisplatin after the last dose of study treatment respectively for each molecule.\n19. Has previously received treatment with an anti-PD-1 or anti-PD-L1 agent for the treatment of the cancer for which the patient is included in the trial, whether as part of the primary treatment or as part of the relapse.\n20. Has a known history of human immunodeficiency virus (HIV) infection.\n21. Has known active hepatitis B or C.\n22. Received a live vaccine within 30 days before the planned start of study treatment.\n23. Has a known history of hypersensitivity to fluorouracil, carboplatin, cisplatin or pembrolizumab or to any of their excipients, according to the SmPCs of these products.\n24. For patient receiving the treatment with 5-fluorouracil: has clinically significant active heart disease or myocardial infarction within 6 months; has received a recent or has a concomitant treatment with brivudine (4 weeks before or after 5-FU).\n25. For patient receiving the treatment with cisplatin: has a neuropathy caused by cisplatin, has a hearing problem, has a treatment with phenytoin with prophylactic aim.\n26. For patient receiving the treatment with pembrolizumab: has a history of uncontrolled or symptomatic cardiac disease.\n27. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure\n28. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)",{"count":468,"type":23},86,[53],"This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.\n\nA total of 86 patients will have to be enrolled in this study.",[29],[29,327,473,474,475],"Cisplatin","Carboplatin","5-fluorouracil","2026-02-09",{"date":478,"type":34},"2026-02-11",{"date":480,"type":34},"2024-10-21",{"date":482,"type":23},"2030-09",{"name":484,"class":111},"Institut Claudius Regaud",14,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":296,"enrollmentInfo":494,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":500,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":112},"100623704","phase-2-neoadjuvant-chemoimmunotherapy-camrelizumab--paclitaxel--carboplatin-for-resectable-hnscc-100623704","NCT07400094","Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC","Prospective Non-Randomized Phase II Study of Neoadjuvant Camrelizumab Combined With Paclitaxel and Carboplatin in Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity and Larynx (Stage III-IVA)","NeoCamre-HN","Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma of the oral cavity and\u002For larynx, Stage III-IVA (cT1-2N1-2M0, cT3-4aN0-2M0)\n* Resectable disease planned for surgical treatment\n* Age 18-75 years\n* No prior antitumor therapy for the current diagnosis\n* Tumor sample available for PD-L1 expression assessment\n* No other malignancies in anamnesis (except basal cell carcinoma of skin and carcinoma in situ of cervix)\n* Absence of comorbidities preventing systemic chemotherapy and immunotherapy\n\nExclusion Criteria:\n\n* Patient refusal to undergo planned treatment\n* Protocol violations not related to medical indications",{"count":96,"type":23},[53],"This phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and\u002For larynx.\n\nFifty patients will receive 3 cycles of therapy (camrelizumab 200 mg IV, paclitaxel 175 mg\u002Fm2 IV, carboplatin AUC6 IV, Day 1 every 21 days) followed by radical surgery 4-6 weeks later. Patients are then stratified to risk-adapted adjuvant therapy based on pathological findings (radiation or chemoradiation with cisplatin if adverse features present).\n\nThe primary endpoint is the pathological complete response (pCR) rate and major pathological response (MPR, \\\u003C10% viable tumor cells) rate at surgery. Secondary endpoints include objective response rate (ORR) by imaging (MRI\u002FPET-CT), correlation of PET-CT metabolic response with pathological response, proportion requiring adjuvant chemoradiation, and 3-year event-free survival compared to historical controls.\n\nStudy period: 2026-2029.",[29,498,499],"Laryngeal Neoplasms","Oral Cavity Neoplasm",[501,502,503,504,474,505,506],"Head and Neck Squamous Cell Carcinoma","Neoadjuvant Therapy","Camrelizumab","Paclitaxel","Pathological Complete Response","PD-1 Inhibitor","2026-02-03",{"date":509,"type":34},"2026-02-10",{"date":511,"type":23},"2026-02",{"date":513,"type":23},"2029-02",{"name":515,"class":111},"National Medical Research Radiological Centre of the Ministry of Health of Russia",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":24,"phases":525,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":553},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":524,"type":23},250,[26],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[528,529,530,29,531,532,218,533,534,63,535,56,536,219,537,538,539,540,541,542,543,544],"Advanced Solid Tumor","Advanced Cancer","Metastatic Cancer","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Sarcoma","Endometrial Cancer","Castration Resistant Prostatic Cancer","Colorectal Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)",{"date":546,"type":34},"2026-02-05",{"date":548,"type":34},"2024-03-06",{"date":550,"type":23},"2028-10",{"name":552,"class":41},"MacroGenics",12,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":24,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":260},"100604555","phase-1-phase-12-study-to-evaluate-th9619-in-the-treatment-of-advanced-solid-tumors-100604555","NCT07151040","Phase 1\u002F2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors","A First-in-human, Phase 1\u002F2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors","ODIN","Inclusion Criteria:\n\n* Must have given written informed consent\n* Histopathologically confirmed advanced cancer (colorectal cancer, head and neck squamous cell cancer, non-small cell lung cancer and gastric cancer (including gastroesophageal junction cancer))\n* Prior treatment with at least one line of cytotoxic systemic therapy for metastatic\u002Funresectable cancer\n* Adult patients (≥18 years of age)\n* Must be willing to comply with study procedures\n\nExclusion Criteria:\n\n• History or presence of any clinically significant disorders as judged by the Investigator.",{"count":563,"type":23},43,[26,53],"This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.",[567,568,29,569,570,219],"Solid Tumor","Colorectal Cancer (CRC)","Non-Small Cell Lung Cancer (NSCLC)","Gastrooesophageal Junction Cancer","2026-01-27",{"date":573,"type":34},"2026-01-28",{"date":575,"type":34},"2025-08-22",{"date":577,"type":23},"2026-12",{"name":579,"class":41},"One-carbon Therapeutics AB",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":24,"phases":589,"briefSummary":591,"conditions":592,"keywords":596,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":144},"100481804","early-phase-1-drug-screening-using-novel-imd-in-salivary-and-head-and-neck-cancers-100481804","NCT05553782","Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers","Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study","Inclusion Criteria:\n\n* Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition).\n* Age 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.\n\n  \\- Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.\n* Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000\u002FmcL, PT\u002FINR \\\u003C2, and aPTT \\\u003C1.5x upper limit of normal.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit the safety of a biopsy and\u002For surgery.\n* Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery\u002Fdevice placement.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon",{"count":588,"type":23},30,[590],"EARLY_PHASE1","This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers\u002F\n\nThe name of the study intervention involved in this study is:\n\n\\-- implantable microdevice",[593,594,29,595],"Salivary Gland Cancer","Adenoid Cystic Carcinoma of the Salivary Gland","Head and Neck Cancer",[593,594,597,29],"Implantable Microdevice IMD","2026-01-23",{"date":36,"type":34},{"date":601,"type":34},"2023-11-01",{"date":603,"type":23},"2029-08-01",{"name":605,"class":111},"Brigham and Women's Hospital",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":24,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":361},"100555738","phase-1-a-study-of-dm005-in-patients-with-advanced-solid-tumors-100555738","NCT06515990","A Study of DM005 in Patients With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Common inclusion criteria for both Parts\n\n  1. Participants must have the ability to understand and willingness to sign a written informed consent document.\n  2. Participants who have pathologically or cytologically documented metastatic\u002Fadvanced NSCLC, gastroesophageal cancer, CRC, HCC, pancreatic cancer, or HNSCC, not curable with standard local therapies (i.e., surgery and\u002For radiation) and have progressed on standard therapy, or intolerant to standard therapy.\n  3. Participants must be ≥18 years of age on the day of signing the informed consent form (ICF).\n  4. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2.\n  5. Has a life expectancy ≥3 months.\n  6. Has measurable disease based on response evaluation criteria in solid tumors (RECIST) version 1.1.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  1. Participants have another active invasive malignancy within 5 years, with the following exceptions and notes:\n\n     * History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission years after treatment with curative intent is allowed.\n     * Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).\n  2. Current or history of hematologic malignancy.\n  3. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.\n  4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n  5. Presence of bulky disease (defined as any single mass \\>7 cm in its greatest dimension). Individuals with a mass \\>7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.\n  6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n  7. Has clinically significant corneal disease.\n  8. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (for both genders) based on average of the Screening triplicate 12-lead ECG determinations; no concomitant medications that would prolong the QT interval; no known family history of long QT syndrome.\n  9. Left ventricular ejection fraction (LVEF) \\\u003C50% by either an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan within 28 days before first dose of the study drug.\n  10. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies\u002Fml or 500 IU\u002Fml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.\n  11. Known human immunodeficiency virus (HIV) infection which is not well controlled. participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee. All the following criteria are required to define an HIV infection (positive HIV1\u002F2 antibodies test) that is well controlled: HIV viral load \\\u003C400 copies\u002FmL, CD4+ T-cell counts ≥350 cells\u002FμL, no history of acquired immunodeficiency syndrome \\[AIDS\\])-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.\n  12. Participants from endemic area will be specifically screened for tuberculosis. Participants with active tuberculosis are excluded. Participants who have received bacille Calmette-Guerin (BCG) vaccination may have a false positive result in the purified protein derivative (PPD) skin test. These participants are eligible if they have a negative Interferon Gamma Release Assay (IGRA).\n  13. Has received a live vaccine within 30 days prior to the first dose of study drug.\n  14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to NCI-CTCAE version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrollment\u002Frandomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.\n  15. Females who are pregnant or lactating or who intend to become pregnant during participation in the study.\n  16. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.",{"count":614,"type":23},136,[26],"The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit.\n\nParticipants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.",[133,29,618],"Solid Carcinoma","2026-01-13",{"date":621,"type":34},"2026-01-15",{"date":623,"type":34},"2024-10-31",{"date":625,"type":23},"2027-03",{"name":627,"class":41},"Doma Biopharmaceutical（Suzhou）Co., Ltd.",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":296,"enrollmentInfo":636,"targetDuration":4,"studyType":24,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":459},"100403063","optimised-early-management-of-squamous-cell-carcinoma-of-the-head-and-neck-cancer-100403063","NCT04528420","Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer","Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck","OPTINECK","Inclusion Criteria:\n\n* Male or female, over 18 and under 75 years of age,\n* Worl Health Organisation score \\\u003C 2,\n* Treatment for a localized squamous cell carcinoma of the head and neck for which a curative treatment by concomitant post-operative radiochemotherapy based on cisplatin is retained,\n* Having signed the informed consent,\n* Affiliate or beneficiary of a social protection scheme.\n\nExclusion Criteria:\n\n* History of other neoplastic disease less than 2 years old or progressive,\n* History of radiotherapy for head and neck cancer,\n* Contraindications to cisplatin,\n* Pregnant or breastfeeding woman,\n* Protected major (under guardianship or curatorship),\n* Patient participating in a therapeutic study\n* Patient unable to understand the study for any reason or to comply with the constraints of the trial",{"count":637,"type":23},138,[300],"Post-operative concomitant radiochemotherapy is a treatment that is difficult to achieve for several reasons. First of all, and by definition, these patients have had recent surgery, most often accompanied by several weeks of hospitalization and weight loss. In addition, the functional recovery of feeding capacity is not always complete at the time of the start of irradiation. In addition, concomitant radiochemotherapy is responsible for very frequent radiomucitus which alters the feeding capacity of patients during treatment.\n\nIn total, the rate of complete radiochemotherapy (3 cures of cisplatin administered) varies from 50 to 70% depending on the studies, which were carried out in selected populations within the framework of an experimental clinical trial and without distinguishing between positive and negative Human Papilloma tumours . In our experience, in a population with a very high preponderance of non-Human Papilloma-related tumours and not selected by participation in an experimental trial, complete radiochemotherapy is only possible in about 40% to 50% of cases.However, the amount of cisplatin actually administered is correlated with overall survival. Therefore, it is logical to assume that increasing the number of patients receiving full treatment may result in increased survival.\n\nWhile the need for nutritional care during radiotherapy is clearly established, its modality remains debated. Recently, a randomised study of 159 patients treated by radiotherapy (or radiochemotherapy) showed that the simple systematic prescription of oral food supplements (500 kcal\u002Fd) in addition to the usual dietary advice was associated with a lesser reduction in weight at the end of radiotherapy (main objective) but also with an improvement in the tolerance of the treatments. Overall, nutritional management during treatment varies greatly, ranging from simple dietary monitoring to prophylactic gastrostomy and the insertion of a nasogastric tube on demand during treatment. This heterogeneity of management found in the literature is also observed at the regional level. This project will also make it possible to propose a harmonized support strategy at the inter-regional level.",[29],[642,643,644,645],"radiochemotherapy","nutrition","support care","early management","2025-12-29",{"date":648,"type":34},"2026-01-02",{"date":650,"type":34},"2020-11-26",{"date":652,"type":23},"2028-06-01",{"name":654,"class":111},"Centre Henri Becquerel",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":663,"phases":4,"briefSummary":664,"conditions":665,"keywords":669,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":112},"100562658","tumor-informed-ctdna-testing-for-mrd-following-treatment-of-squamous-cell-carcinoma-100562658","NCT06606028","Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma","Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.\n2. Participants must be age \\>=18 years.\n3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.\n4. Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1\\. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).",{"count":524,"type":23},"OBSERVATIONAL","This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.",[29,666,667,668],"Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma of Skin","Cutaneous Squamous Cell Carcinoma (CSCC)",[670],"ctDNA","2025-12-04",{"date":673,"type":34},"2025-12-12",{"date":675,"type":34},"2024-10-09",{"date":677,"type":23},"2029-12-30",{"name":679,"class":111},"University of California, San Francisco",{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":296,"enrollmentInfo":687,"targetDuration":4,"studyType":24,"phases":689,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":112},"100490648","phase-1-a-study-of-si-b001si-b003-chemotherapy-in-patients-with-locally-advanced-or-metastatic-head-and-neck-squamous-cell-carcinoma-100490648","NCT05668858","A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma","A Phase Ib\u002FII Clinical Study of SI-B001+SI-B003 Dual-drug No-combination or Combined Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Histologically or cytologically confirmed head and neck squamous cell carcinoma occurring only in the oral cavity, oropharynx, hypopharynx, and larynx;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Performance status score: ECOG ≤1;\n9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n14. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.\n\nExclusion Criteria:\n\n1. Squamous cell carcinoma originating from the nasopharynx, salivary glands, nasal sinuses, skin, or with an unknown primary site;\n2. For Phase II patients, either: a) those suitable for and willing to undergo local therapy; or b) those who have received systemic chemotherapy, excluding chemotherapy administered as part of multimodal treatment for locally advanced disease;\n3. Patients with central nervous system (CNS) metastases and\u002For carcinomatous meningitis (leptomeningeal metastases) and\u002For spinal cord compression;\n4. Participation in any other clinical trial within 4 weeks prior to the administration of this trial's investigational product (based on the last dose date);\n5. Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first dose of the study drug;\n6. Major surgery (as defined by the investigator) within 4 weeks prior to the first dose;\n7. Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before the study drug administration;\n8. Pulmonary diseases graded as ≥Grade 3 according to NCI-CTCAE v5.0; current or history of interstitial lung disease (ILD);\n9. Active infection requiring intravenous anti-infective therapy;\n10. Prior immunotherapy leading to ≥Grade 3 immune-related adverse events (irAE) or ≥Grade 2 immune-related myocarditis;\n11. Use of live attenuated vaccines within 4 weeks before the first dose of the study drug;\n12. Use of immunomodulatory drugs (including but not limited to thymosin, interleukin-2, interferon, etc.) within 14 days before the first dose of the study drug;\n13. Patients at risk of active autoimmune diseases or with a history of autoimmune diseases;\n14. History of other malignancies within 5 years before the first dose;\n15. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;\n16. Poorly controlled hypertension (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg);\n17. History of severe cardiovascular or cerebrovascular diseases;\n18. Previous allogeneic stem cell, bone marrow, or organ transplantation;\n19. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;\n20. History of hypersensitivity to recombinant humanized antibodies or any excipients of SI-B001 or SI-B003;\n21. History of severe infusion reactions (CTCAE Grade ≥3) to antibody therapy;\n22. History of autologous or allogeneic stem cell transplantation;\n23. Pregnant or lactating women;\n24. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.",{"count":688,"type":23},130,[26,53],"Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 in combination and to identify RP2D in locally advanced or metastatic head and neck squamous cell carcinoma indications. Initial efficacy, pharmacokinetic characteristics and immunogenicity were evaluated. Phase II: To evaluate the efficacy of SI-B001+SI-B003 two-drug combination chemotherapy. Safety and tolerance, PK\u002FPD, immunogenicity were evaluated.",[29],"2025-09-25",{"date":694,"type":34},"2025-09-26",{"date":696,"type":34},"2023-02-10",{"date":698,"type":23},"2027-12",{"name":700,"class":41},"Sichuan Baili Pharmaceutical Co., Ltd."]