[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-neoplasms":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,80,93,129,157,186,217,247,273,305,321,342,367,387,420,477,504,528,562,585,608,632,659,685,718],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100053960","phase-1-intratumoral-n17350-in-advanced-solid-tumors-100053960",false,"NCT07339176","Intratumoral N17350 in Advanced Solid Tumors","A Phase 1\u002F2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors","OP-NEU-101","Inclusion Criteria:\n\n1. Age ≥18 years (or legal age of consent in the study jurisdiction).\n2. Able to provide written informed consent and willing\u002Fable to comply with study procedures, visits, and follow-up.\n3. Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.\n4. ECOG performance status 0-1.\n5. Measurable disease per IT-RECIST (Parts A1\u002FA2) and RECIST v1.1 (Part A3), as applicable.\n6. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe\u002Faccessible for injection:\n\n   1. Superficial lesions: ≥10 mm in longest diameter (or multiple lesions each ≥5 mm with aggregate longest diameter ≥10 mm), and ≤80 mm, accessible for direct injection (± ultrasound guidance).\n   2. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection.\n   3. Injected lesions must not involve\u002Fencase major blood vessels or otherwise pose an unacceptable bleeding\u002Fvascular risk, per investigator assessment and imaging review (as applicable).\n   4. Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection.\n7. Adequate recovery from prior therapy: toxicities from prior anticancer treatment resolved to Grade ≤1 or baseline (except alopecia, controlled endocrine toxicities, or other stable toxicities as allowed per protocol\u002Fsponsor).\n8. Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds.\n9. Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds.\n10. Tumor tissue requirements: willingness to provide a pre-treatment tumor biopsy and on-study post-treatment biopsy, if an accessible lesion is available and safe for biopsy, and biopsy does not interfere with injection\u002Fresponse assessment; and\u002For availability of archival tumor tissue (obtained within 2 years prior to treatment), per protocol.\n11. Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy\u002Ffathering children from screening through 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose, per protocol.\n\nExclusion Criteria:\n\n1. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.\n2. History of solid organ transplant.\n3. Alpha-1 antitrypsin deficiency.\n4. Hereditary or acquired bleeding disorder\u002Fcoagulation factor deficiency.\n5. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol).\n6. Baseline QTcF \\>480 ms.\n7. Pregnant or breastfeeding.\n8. Prior severe immune-mediated adverse event (imAE) from immunotherapy: ≥Grade 3 imAE within the past 16 weeks, any Grade 4 life-threatening imAE, or any neurologic\u002Focular AE of any grade (except controlled endocrine AEs on stable replacement therapy per protocol).\n9. Another active malignancy (current or within the past 2 years) other than the disease under study, except specified low-risk cancers treated with curative intent or under active surveillance (per protocol).\n10. Recent anticancer therapy: receipt of systemic anticancer therapy (including investigational agents) within 2 weeks prior to first dose (or 4 weeks for monoclonal antibodies\u002FADCs\u002Fother long half-life biologics), or within 5 half-lives, whichever is shorter.\n11. Recent radiotherapy within 2 weeks prior to first dose.\n12. Unresolved toxicity from prior anticancer therapy to \\>Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol).\n13. Uncontrolled or unstable brain metastases (eligible only if neurologically stable for ≥4 weeks, and off steroids or on stable\u002Fdecreasing steroids ≤10 mg\u002Fday prednisone equivalent; carcinomatous meningitis excluded).\n14. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.\n15. Chronic viral infections not meeting protocol criteria:\n\n    1. HBV with detectable DNA unless on appropriate antiviral therapy\n    2. Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable)\n    3. HIV infection with CD4+ count \\\u003C300\u002FμL, detectable viral load, or HIV-related illness within 6 months\n16. Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose.\n17. Chronic systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent, or systemic immunosuppressive\u002Fanti-inflammatory medications within 4 weeks prior to first dose, except permitted topical\u002Finhaled\u002Flocal formulations or short courses for premedication per protocol.\n18. Known allergy\u002Fhypersensitivity to N17350 or any excipients.","ALL","18 Years",{"count":21,"type":22},275,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies.\n\nThe main questions it aims to answer are:\n\n1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?\n2. Are there any side effects for participants when taking N17350?\n3. What is the safest dose of N17350 and the dose that should be used for further study?\n4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo.\n\nParticipants will:\n\n1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks\n2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects\n3. Have imaging scans (such as CT or MRI) to measure tumors and assess response\n4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system",[29,30,31,32,33,34,35],"Neoplasms, Solid Tumor","Breast Neoplasms, Triple-Negative","Squamous Cell Carcinoma of Skin","Melanoma","Head and Neck Neoplasms","Carcinoma, Squamous Cell","Carcinoma, Non-Small-Cell Lung",[37,38,39,40,41,42,43,44,45,46,47,48,49,50,32,51,52,16,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"N17350","Intratumoral injection","Intralesional injection","Dose escalation","Dose finding","Dose expansion","Phase 1","Open-label","Safety","Tolerability","Biomarkers","Advanced solid tumors","Triple-negative breast cancer","Cutaneous squamous cell carcinoma","Head and neck squamous cell carcinoma","Non-small cell lung cancer","Onchilles","Onchilles Pharma","ELANE","Phase 2","ELANE pathway","TNBC","cuSCC","HNSCC","SCCHN","metastatic","elastase","therapeutic elastase","neutrophil elastase","New cancer therapy","RECRUITING","2026-07-10",{"date":70,"type":71},"2026-07-13","ACTUAL",{"date":73,"type":71},"2026-05-25",{"date":75,"type":22},"2029-11",{"name":77,"class":78},"Onchilles Pharma Inc","INDUSTRY",6,{"id":81,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":27,"conditions":84,"keywords":85,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":91,"locationsCount":92},"100619019",{"count":21,"type":22},[25,26],[29,30,31,32,33,34,35],[37,38,39,40,41,42,43,44,45,46,47,48,49,50,32,51,52,16,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"2026-06-17",{"date":88,"type":71},"2026-06-22",{"date":73,"type":71},{"date":75,"type":22},{"name":77,"class":78},2,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100318690","biospecimen-procurement-for-head-and-neck-disorders-100318690","NCT03429036","Biospecimen Procurement for Head and Neck Disorders","Biospecimen Procurement for the Study of Head and Neck Disorders","* INCLUSION CRITERIA:\n* Age 3 and older.\n* Able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.\n* Diagnosis of a condition of the head and neck for which removal of biological specimens was indicated for clinical care or for research purposes under a separate Review Board (IRB) approved protocol.\n* Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Part 1:\n\n  --Are unwilling to share waste specimens for research purposes\n* Part 2: Additional exclusion criteria for the Part 2 prospective sample collection part of this protocol these criteria may be assessed prior to collection of the samples but will not affect overall eligibility for the trial (i.e., Part 1):\n\n  * have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction\n  * have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the participants risk in participating. This will be determined at the discretion of the principal investigator\n  * Individuals under the age of 18 are excluded from oral mucosal biopsies and skin biopsies","3 Years","120 Years",{"count":103,"type":22},1000,"OBSERVATIONAL","Background:\n\nResearchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.\n\nObjective:\n\nTo create a repository of tissue samples and data to better study conditions of the head and neck.\n\nEligibility:\n\nPeople who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.\n\nDesign:\n\nParticipants will be screened with a questionnaire, medical history, and physical exam.\n\nPart 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.\n\nIf participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.\n\nPart 2: Participants will have additional samples collected. These could be:\n\n* Blood: Blood is drawn through a needle in the arm.\n* Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.\n* Saliva: They rinse their mouth with water and spit into a tube or cup.\n* Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.\n* Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.\n\nParticipants samples will be used for future research, including genetic testing.",[107,108,109,33,110],"Hearing Disorder","Oral Mucosal Disease","Pharyngeal Neoplasm","Laryngeal Disease",[112,113,114,115,116,117],"Genomic DNA","DNA Banking","Tissue Sample","Saliva","Blood Collection","Natural History","2026-06-10",{"date":120,"type":71},"2026-06-11",{"date":122,"type":71},"2018-05-23",{"date":124,"type":22},"2029-12-02",{"name":126,"class":127},"National Cancer Institute (NCI)","NIH",9,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":156},"100501644","the-snap-tool-for-head-and-neck-cancer-survivor-caregiver-dyads-100501644","NCT05811936","The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads","A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads","SNAP","Patient Inclusion Criteria:\n\n1. Age \\>18\n2. Stage I-IV non-metastatic HNC (i.e., lip\u002Foral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)\n3. Currently receiving radiation treatment (with\u002Fwithout surgery and\u002For concurrent chemotherapy) with curative intent\n4. Able to nominate caregiver, the primary support person, also interested in participating\n\nCaregiver Inclusion Criteria:\n\n1. Age \\>18\n2. Provide care for a loved one with stage I-IV HNC\n3. Agrees to participate after being nominated\n\nPatient Exclusion Criteria:\n\n1. Patients who do not read\u002Funderstand English\n2. Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider\n3. Patients concurrently diagnosed with and\u002For receiving treatment for a second \"significant\" primary cancer, except the following:\n\n   * Excised and cured non-melanoma skin cancer\n   * Carcinoma in situ of breast or cervix\n   * Superficial bladder cancer\n   * Stage 1 differentiated thyroid cancer that is resected or observed\n   * pT1a\u002FpT1b prostate cancer comprising \\\u003C5% of resected tissue with normal prostate specific antigen (PSA) since resection\n   * cT1a\u002FcT1b prostate cancer treated with brachytherapy\n\nCaregiver Exclusion Criteria:\n\n1. Inability to read or understand English\n2. Cognitively impaired and cannot complete interviews, as judged by the referring health care provider",{"count":138,"type":22},352,[140],"NA","In this randomized behavioral intervention, head and neck cancer (HNC) survivors and their caregivers (N=176 HNC survivor-caregiver dyads) will be randomized to either Survivorship Needs Assessment Planning (SNAP) or Usual Care (UC) groups to examine the effects of SNAP on outcomes. SNAP includes two sessions with a needs assessment and tailored care plan and a supportive mobile app after completion of radiation to promote uptake of recommended medical and supportive care. The study aims to evaluate the effects of SNAP on symptom severity in patients and caregiver burden in caregivers. Secondary outcomes include psychological distress (anxiety and depression), healthcare utilization (receipt of recommended care) and unmet needs and self-efficacy in HNC survivor-caregiver dyads. Participants will complete surveys at baseline, 6 months, and 9 months post randomization with validated PROMs, and receive intervention modules at the end of radiation and month 3. Participants in the SNAP group will also receive mobile app support.",[143,144,145,33],"Head and Neck Cancer","Survivorship","Caregiver Burden",[143,144],"2026-06-09",{"date":120,"type":71},{"date":150,"type":71},"2023-08-23",{"date":152,"type":22},"2027-12-31",{"name":154,"class":155},"Medical University of South Carolina","OTHER",1,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":156},"100551317","evaluation-of-two-methods-of-administration-of-photobiomodulation-in-the-context-of-the-prevention-and-treatment-of-mucositis-induced-by-radiotherapy-during-the-treatment-of-head-and-neck-cancers-100551317","NCT06458517","Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers","Pilot Observational Study of Transcutaneous and Intraoral Photobiomodulation in the Prevention and Treatment of Radiomucositis in Head and Neck Cancers Treated by Radiotherapy - RADIO-PBM Trial","RADIO-PBM","Inclusion Criteria:\n\n* Adult patient (18 years old and older);\n* Patients with oral cavity or oropharynx cancer treated with radiotherapy or chemo-radiotherapy;\n* Karnofsky Performance Status \\> 60%;\n* Able to understand French;\n* With signed informed consent;\n* Affiliated to French Health Security Insurance\n\nExclusion Criteria:\n\n* Allergy to polyurethanes;\n* Head and Neck tumors that are localized to other sites than oral cavity or oropharynx\n* Previous irradiation of Head and Neck (whatever the time lapse between the two irradiations)\n* Pregnant and breastfeeding woman;\n* Patients with pacemaker device\n* Epileptic patients;\n* Concomitant treatment or treatment within the 7 days before inclusion with one of several drugs from the following list: fluoroquinolones, cycline, methotrexate, auranofin\n* Patients with ophthalmic diseases (such as maculopathy, retinopathy, glaucoma and cataract, retinal damage)\n* Patients under judicial protection",{"count":166,"type":22},60,[140],"The aim of this feasibility, prospective, single-center trial is to compare an intra-oral Photobiomodulation (PBM) via the Caremin650TM device (NeoMedLight) and a transcutaneous PBM via the ATP 38® device (Swiss Bio Innov) in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity. PBM session will be carried out first at the rate of two sessions per week for preventive purposes, and then, in case of occurence of grade 1 mucositis, three sessions per week with curative purpose.",[33],[171,172,173,174,175],"Radiotherapy","Chemotherapy","Photobiomodulation therapy","Low-level laser therapy","Oral mucositis","NOT_YET_RECRUITING","2026-06-04",{"date":179,"type":71},"2026-06-05",{"date":181,"type":22},"2026-06-15",{"date":183,"type":22},"2029-11-15",{"name":185,"class":155},"Centre Paul Strauss",{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":206,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100643560","phase-2-an-exploratory-study-of-zanidatamab-in-her2-positive-advanced-tumor-after-at-least-one-line-of-standard-therapy-100643560","NCT07631871","An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced\u002Fmetastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H\u002FdMMR tumors if clinically indicated.\n3. ECOG Performance Status 0, 1 or 2.\n4. Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).\n5. Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.\n6. At least one measurable lesion at baseline per RECIST 1.1 criteria.\n7. Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 75,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1000\u002Fmm³; Serum albumin ≥ 2.5 g\u002FdL; PT, aPTT and INR ≤ 1.5 × ULN; AST\u002FALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible:\n\n1. Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.\n2. Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy, ongoing active ILD\u002Fnon-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by screening imaging.\n4. History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.\n5. Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.\n6. Confirmed presence of HER2 gene mutation.",{"count":193,"type":22},10,[26],"The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg\u002Fkg per cycle.",[197,198,199,200,201,202,203,33,204,205],"Neoplasms","Solid Tumors","HER2 Positive Solid Tumor","Endometrial Neoplasm","Urothelial Carcinoma (UC)","Pancreatic Neoplasms","Colorectal Neoplasms","Cervical Neoplasms","Ovarian Neoplasms",[199,207,208],"Zanidatamab","Basket Study","2026-06-02",{"date":211,"type":71},"2026-06-08",{"date":181,"type":22},{"date":214,"type":22},"2029-12-31",{"name":216,"class":155},"Haihua Yuan",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":238,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":244,"leadSponsor":246,"locationsCount":4},"100643697","phase-2-exploratory-study-on-the-efficacy-and-safety-of-trastuzumab-rezetecan-in-the-treatment-of-her2-expressiong-advanced-solid-tumor-100643697","NCT07631884","Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male and female participants aged 18 years or older.\n2. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced\u002Fmetastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).\n5. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.\n6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:\n\n   Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 100,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³; Serum albumin ≥ 3.0 g\u002FdL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions are ineligible for this study:\n\n1. Presence of any severe and\u002For uncontrolled diseases:\n\n   * Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n   * Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \\[NYHA\\] classification).\n   * Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.\n   * History of active tuberculosis.\n   * Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.\n2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL.Hepatitis C: HCV RNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002FmL must receive concurrent antiviral treatment throughout the study for enrollment.\n3. History of immunodeficiency diseases, including HIV positivity or other acquired\u002Fcongenital immunodeficiency disorders.\n4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.\n6. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n7. Unhealed or poorly healing wounds, or active ulcers.\n8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.\n9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.\n10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.",{"count":224,"type":22},15,[26],"The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.\n\nThe main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg\u002Fkg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.",[198,228,229,230,231,232,233,234,235,201,202,203,236,237,33,204],"Neoplasms (Cancer \u002F Tumors)","Advanced Malignant Solid Neoplasm","Locally Advanced Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","HER2 Expression","Biliary Tract Neoplasms","Endometrial Neoplasms","Gastric Neoplasms","Non-Small Cell Lung Carcinoma (NSCLC)",[239,240,241],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor",{"date":211,"type":71},{"date":181,"type":22},{"date":245,"type":22},"2028-12-31",{"name":216,"class":155},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":262,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":156},"100471597","phase-2-a-study-of-pembrolizumab-in-combination-with-chemotherapy-for-head-and-neck-cancer-100471597","NCT05420948","A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer","A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)","Inclusion Criteria:\n\n* Have clinically confirmed head and neck cancer that is recurrent (comes back\u002Freturns to the body) or metastatic (spreads to other parts of the body).\n* Participants should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 3 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.\n* Greater than or equal to 18 years old.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have measurable disease based on RECIST 1.1 as determined by the site. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participants must have normal organ and marrow function as defined by clinical lab values.\n* Participants must have provided tissue for programmed cell death ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate). Repeat samples may be required if adequate tissue is not provided. A newly obtained biopsy (within 90 days prior to start of study treatment) is strongly preferred, but an archival sample is acceptable.\n* Measurable disease (either primary site and\u002For nodal disease) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Participants must sign a study-specific informed consent form prior to study entry. Participants should have the ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug.\n* Women must not be breastfeeding.\n* Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.\n* Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).\n\nExclusion Criteria:\n\n* Has disease that is suitable for local therapy administered with curative intent.\n* Has progressive disease (PD) within three (3) months of completion of curatively intended systemic treatment for locoregionally advanced head and neck cancer.\n* Participants who are receiving any other investigational agents.\n* Participants in whom signatera ctDNA is not measurable at baseline.\n* Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment or patient has not fully recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered treatment.\n\n  * Note: Participants with ≤Grade 2 neuropathy, ≤Grade 2 alopecia, are an exception to this criterion and may qualify for the study.\n  * Note: If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Active, known, or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low-dose prednisone (\\\u003C= 10mg or equivalent). The following are exceptions to these criteria:\n* Participants with vitiligo or alopecia.\n* Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n* Any chronic skin condition that does not require systemic treatment.\n* Has a life expectancy of less than 3 months and\u002For has rapidly progressing disease (e.g. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.\n* Participants with a \"currently active\" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for ≥ 3 years.\n* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in study.\n* Has received prior therapy with an anti-PD1(anti-programmed cell death protein1) therapy.\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 compliance with study requirements.\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Pregnant women are excluded from this study because pembrolizumab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued if the mother is treated with pembrolizumab. These potential risks may also apply to other agents used in this study.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pembrolizumab, carboplatin, and paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Has known active Hepatitis B or Hepatitis C. However, if eradicated participant is eligible.\n* Has a history of active infection requiring systemic therapy.\n* Has received a live vaccine within 28 days of planned start of study therapy. Note: Vaccines for COVID-19 are allowed except for any live vaccine that may be developed.",{"count":255,"type":22},30,[26],"By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.",[143,259,33,260,261],"Head and Neck Squamous Cell Carcinoma","Head Cancer","Throat Carcinoma",[263],"head and neck cancer","2026-05-08",{"date":266,"type":71},"2026-05-12",{"date":268,"type":71},"2022-10-17",{"date":270,"type":22},"2026-12-01",{"name":272,"class":155},"University of Chicago",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":281,"sex":18,"minAge":19,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":156},"100453634","phase-3-the-swoar-trial-sparing-of-swallowing-and-aspiration-related-organs-at-risk--submandibular-gland-with-intensity-modulated-radiotherapy-versus-standard-imrt-in-head-and-neck-squamous-cell-carcinomas-100453634","NCT05187091","The SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas","The SWOAR Trial: A Phase III Trial Evaluating Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas","SWOAR","Inclusion Criteria:\n\n1. Aged 18 or above and less than 70 years\n2. Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx.\n3. Stage T1-4, N0-3, M0 disease with histologically confirmed squamous cell carcinoma requiring bilateral neck radiotherapy and where sparing of contra lateral or one submandibular gland is possible\n4. Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment\n5. Karnofsky performance score greater or equal 70\n6. Available to attend long term follow- up;\n7. Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.\n8. Willingness to undergo FEES.\n9. Written informed consent for treatment.\n10. Available to attend long term follow- up\n\nExclusion Criteria:\n\n1. Early Carcinoma Glottis (T1-T2, N0M0)\n2. Metastatic disease.\n3. Previous radiotherapy to the head and neck region\n4. Lateralised tumours, requiring unilateral irradiation\n5. Patients requiring radiation to both submandibular glands\n6. Evidence of pre-existing swallowing dysfunction (not related to HNC);\n7. Major head and neck surgery (excluding biopsies\u002Ftonsillectomy);\n8. Tracheostomy placement\n9. Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy, trial assessments or follow-up\n10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).",true,"70 Years",{"count":284,"type":22},136,[286],"PHASE3","The aim of SWOAR TRIAL is to test sparing of Dysphagia\u002F Aspiration risk structures (DARS) and contra lateral submandibular gland by IMRT. HNSCC of the oropharynx, larynx and the hypopharynx treated with radical concurrent chemoradiotherapy or radiotherapy will be included in the trial. Patients will be randomized to SWOAR IMRT or standard IMRT.\n\nSwallowing function will be evaluated the MD Anderson Dysphagia Inventory (MDADI) scoring. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial.\n\nSecondary Objectives include longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Swallowing function, will be assessed by using the MDADI at baseline, at completion of CRT\u002FRT, 3, 6, 12, and 24 months.\n\nAssessment of acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, and 24 months post treatment as per RTOG and LENT SOMA score, respectively.\n\nTreatment outcomes will be assessed in terms of loco-regional tumor recurrence and overall survival, assessed at follow-up visits 3, 6, 12, and 24 months post treatment and then annually until 5 years post treatment.",[33,289],"Swallowing Sparing IMRT",[291,292,293,294,295],"IMRT","Dysphagia","Aspiration","Head and neck cancer","Radiation","2026-04-28",{"date":298,"type":71},"2026-05-04",{"date":300,"type":71},"2021-07-12",{"date":302,"type":22},"2026-12",{"name":304,"class":155},"All India Institute of Medical Sciences",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":311,"phases":4,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":315,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":319,"locationsCount":156},"100478572","expanded-access-11c-methionine-pet-imaging-100478572","NCT05511714","Expanded Access [11C] Methionine PET Imaging","Inclusion Criteria:\n\n* All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation.\n* No limit on age.\n* Patients of all genders and all ethnic groups under the care of a SJCRH physician.\n* Female participants of child-bearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.\n* Informed consent signed by participant, parent, or guardian according to the guidelines of the Institutional Review Board.\n\nExclusion Criteria:\n\n* More than six L-\\[11C\\]methionine PET scans within the previous 12 months.\n* Inability or willingness of patient, parent, or guardian to consent.","EXPANDED_ACCESS","The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment.\n\nPrimary Objective\n\nTo provide expanded access to L-\\[11C\\]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.",[314,33],"Central Nervous System Tumor","AVAILABLE","2026-04-23",{"date":318,"type":71},"2026-04-24",{"name":320,"class":155},"St. Jude Children's Research Hospital",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":156},"100472470","preventive-physical-activity-intervention-in-head-and-neck-cancer-100472470","NCT05432297","Preventive Physical Activity Intervention in Head and Neck Cancer","Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, Function and Quality of Life","Inclusion Criteria:\n\n* Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)\n* Receiving radiohterapy (+\u002F- chemotherapy) with curative intent\n\nExclusion Criteria:\n\n* Surgery due to head and neck cancer\n* Previous treatment for head and neck cancer\n* Tracheostomized patients\n* Inability to perform exercise intervention\n* Inability to perform part of 6-minute walking test\n* Inability to independently fill out questionnaires in Swedish\n* Previous neurologic or neuromuscular disease",{"count":329,"type":22},80,[140],"The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+\u002F- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment",[33,333],"Physical Inactivity","2026-04-22",{"date":316,"type":71},{"date":337,"type":71},"2023-01-02",{"date":339,"type":22},"2032-12",{"name":341,"class":155},"Sahlgrenska University Hospital",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":92},"100409483","the-eminence-study---petmr-imaging-of-head-neck-cancer-100409483","NCT04612075","The EMINENCE Study - PET\u002FMR Imaging of Head Neck Cancer","EMINENCE","Inclusion Criteria:\n\n* willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee\n* histologically confirmed squamous cell carcinoma in the head neck region (pharynx, larynx, oral cavity or sinonasal area)\n* locally advanced disease without sign of dissemination (T3\u002FT4 and\u002For N1-3, M0) on diagnostic imaging\n* scheduled for definitive radiotherapy with curative intent with or without concomitant chemotherapy\n* adequate renal function: Creatinine clearance ≥ 60 ml\u002Fminute\n* lymph node metastasis from cancer of unknown primary of the upper neck (i.e. level II-III) were PET\u002FCT is negative outside the head-neck region can be considered for inclusion at the discretion of the study investigators.\n\nExclusion Criteria:\n\n* general contraindications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)\n* serious comorbidity (including previous or othe cancer) that in the opinion of the investigator would compromise the patient's ability to complete the study of interfere with the evaluation of the study objectives (e.g. poorly controlled diabetes mellitus)\n* histologically confirmed SCC of same or other origin within the last five years\n* patient wants to withdraw for any reason during the study",{"count":350,"type":22},390,"Head and neck cancers (HNC) often receive radiotherapy as part of their treatment. However, unacceptable failure rates and severe side effects remain a challenge. The improvements in radiotherapy are closely related to improvements in medical imaging. Functional imaging, where intratumoural characteristics such as tumour oxygenation, metabolism, and blood vessel function can be quantified, offers possibilities to personalize the radiotherapy. In this study we will establish the clinical workflow for PET- and MRI-based radiotherapy in HNC by acquiring images prior to and during radiotherapy to develop new concepts for image-based biologically adaptive radiotherapy, both based on photon-based radiotherapy and also proton therapy, which soon will be available for cancer patients in Norway. The investigators aim to contribute towards further developments of personalised high-precision radiotherapy for HNC patients resulting in improved outcome, reduced side-effects and better quality of life.",[33],[354,355,356,357,171],"Diagnostic Imaging","Functional Imaging","Nuclear magnetic Resonance Imaging","Positron-Emission Tomography","2026-04-09",{"date":360,"type":71},"2026-04-14",{"date":362,"type":71},"2021-01-12",{"date":364,"type":22},"2028-12",{"name":366,"class":155},"Norwegian University of Science and Technology",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":156},"100072749","molecular-and-genomic-profiling-of-head-and-neck-tumors-100072749","NCT00200486","Molecular and Genomic Profiling of Head and Neck Tumors","Molecular and Genomic Profiling of Head and Neck Tumors to Explore Biomarkers Associated With Prognosis and Response to Therapy","Inclusion Criteria:\n\n* actual or suspected malignant or non-malignant tumors of the head and neck\n* planned biopsy and\u002For resection, or availability of paraffin embedded or stored frozen tumor tissue for non-genetic analysis\n\nExclusion Criteria:\n\n* insufficient tissue available for both standard diagnostic evaluation and study specimen",{"count":103,"type":22},"The purpose of this study is to study the genetic profile of head and neck tumors and their relationship to treatment response and outcome",[33],[378,263],"genetic microarray","2026-04-06",{"date":358,"type":71},{"date":382,"type":4},"2002-10-01",{"date":384,"type":22},"2030-12",{"name":386,"class":155},"Montefiore Medical Center",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":156},"100630735","ozone-therapy-with-biomimetic-oral-care-for-cancer-related-oral-mucositis-100630735","NCT07491536","Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis","Combined Gas Ozone Therapy and Biomimetic Oral Care in the Management of Radio- and Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Clinical Trial","OZOMUC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of radio- and\u002For chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale\n* Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers\n* Clinically stable general health condition (ASA physical status I-III)\n* Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Oral mucositis grade 4 according to the WHO Oral Toxicity Scale\n* Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis)\n* Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease)\n* Ongoing head and neck radiotherapy with cumulative dose \\>70 Gy or completion within 7 days prior to enrollment\n* Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents\n* Systemic or topical therapies known to interfere with salivary function or mucosal healing (e.g., anticholinergics, tricyclic antidepressants, diuretics)\n* Known allergy or hypersensitivity to components of the oral care products or materials used during ozone therapy\n* Severe or uncontrolled systemic diseases (including hepatic, renal, respiratory, or cardiac insufficiency)\n* Severe immunosuppression or neutropenia (neutrophils \\\u003C1,000\u002Fmm³)\n* Pregnancy or breastfeeding\n* Alcohol or substance abuse, or any condition that may compromise adherence to the protocol\n* Inability to attend scheduled follow-up visits through Day 30",{"count":396,"type":22},50,[140],"Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment.\n\nThis randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone.\n\nEligible participants will be randomly assigned to one of two parallel groups. The control group will receive gas ozone therapy administered in an outpatient setting according to a standardized protocol. The experimental group will receive the same ozone therapy combined with a defined home oral care regimen. Each participant will be followed for 30 days.\n\nThe primary outcome is the change in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale. Secondary outcomes include oral pain intensity, salivary flow rates, perceived dry mouth, taste alterations, swallowing function, oral pH, overall oral health-related quality of life, and treatment tolerability.\n\nThe findings of this study are expected to clarify the role of ozone-based supportive care strategies in the management of cancer therapy-related oral mucositis and to contribute to the development of standardized non-pharmacological treatment protocols.",[400,401,33],"Oral Mucositis","Chemotherapy-induced Oral Mucositis",[403,404,405,406,143,407,408,409,410],"Ozone Therapy","Cancer Treatment-Induced Oral Mucositis","Supportive Oncology","Non-Pharmacological Treatment","Oral Toxicity","Salivary Function","Xerostomia","Randomized Controlled Trial","2026-03-19",{"date":413,"type":71},"2026-03-24",{"date":415,"type":22},"2026-03-01",{"date":417,"type":22},"2026-12-15",{"name":419,"class":155},"University of Pavia",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":428,"targetDuration":430,"studyType":104,"phases":4,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":476},"100368284","the-momentum-study-the-multiple-outcome-evaluation-of-radiation-therapy-using-the-mr-linac-study-100368284","NCT04075305","The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","MOMENTUM","Inclusion Criteria:\n\n* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;\n* Patient provides written, informed consent;\n* Patient is 18 years old or older.\n\nExclusion Criteria:\n\n* MRI exclusion criteria, including\n* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.",{"count":429,"type":22},8000,"2 Years","The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.",[433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,202,143,33,459,460,197,461,462,463,464,465,466],"Oncology","Breast Cancer","Prostate Cancer","Gynecologic Cancer","Brain Tumor","Brain Cancer","Gynecologic Tumor","Prostate Tumor","Prostate Neoplasm","Breast Tumor","Radiation Toxicity","Quality of Life","Rectal Cancer","Rectal Tumor","Rectal Neoplasms","Lung Cancer","Lung Tumor","Lung Neoplasm","Esophageal Cancer","Esophagus Cancer","Esophageal Tumor","Esophageal Neoplasm","Esophagus Tumor","Esophagus Neoplasm","Pancreatic Cancer","Pancreatic Tumor","Head and Neck Tumor","Tumor","Bladder Cancer","Bladder Neoplasm","Liver Cancer","Liver Neoplasms","Liver Metastases","Oligometastases","2026-03-03",{"date":469,"type":71},"2026-03-05",{"date":471,"type":71},"2019-02-01",{"date":473,"type":22},"2030-08-01",{"name":475,"class":155},"UMC Utrecht",18,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":79},"100481064","phase-2-a-study-of-decreasing-radiation-therapy-and-chemotherapy-in-people-with-head-and-neck-cancer-100481064","NCT05544136","A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer","A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity\u002Fparanasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies).\n\n  * Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and\u002For co-PI approval)\n  * If the primary site is oropharynx or unknown primary, P16 IHC must be negative.\n  * If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible.\n* Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET\u002FCT.\n* 18 years of age or older.\n* Must not have received prior radiation therapy or chemotherapy for HNC.\n* Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study.\n* Karnofsky Performance Status (KPS) ≥ 70.\n* CT or MRI of the Neck with and without contrast\n\n  o Note: A CT scan of the Neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as planning tools.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * White Blood Count (WBC) ≥ 2,000 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 8.0 g\u002FdL; Note: The use of transfusion or other interventions to achieve Hgb ≥ 8.0 g\u002FdL is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002FdL or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \\[(140 - age) x (weight in kg)\\] \u002F \\[(Serum Cr mg\u002FdL) x (72)\\] CrCl female = 0.85 x (CrCl male)\n  * Patients with serum creatinine \\> 1.5 mg\u002FdL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002FdL\n  * AST or ALT \\\u003C 3 x the upper limit of normal\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential.\n* The subject\u002Flegally authorized representative (LAR) must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* All nasopharyngeal, nasal cavity\u002Fparanasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies.\n* Any T4 or N3 patients\n* Any prior radiotherapy to the head and neck region.\n* Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\\&N cancer is permissible.\n* Prior chemotherapy or radiotherapy within the last three years.\n* Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes).\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%.\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  o Note: Exceptions can be made for patients with simultaneous primaries outside the H\\&N if determined by the PI\u002FCo-PI that the patient can proceed with protocol activities.\n* Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding.\n* Severe, active co-morbidities defined as follows:\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 bacterial or fungal infection requiring intravenous antibiotics 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 defects.",{"count":485,"type":22},12,[26],"The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.",[143,489,33,259],"Head and Neck Carcinoma",[491,143,259,492,493,494,495],"Unknown Primary Squamous Cell Carcinoma","fluoromisonidazole","18F-FMISO","Memorial Sloan Kettering Cancer Center","22-227","2026-02-25",{"date":498,"type":71},"2026-02-27",{"date":500,"type":71},"2022-09-12",{"date":502,"type":22},"2027-03-12",{"name":494,"class":155},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":156},"100538301","phase-2-heavy-strength-training-in-head-and-neck-cancer-survivors-100538301","NCT06289049","Heavy Strength Training in Head and Neck Cancer Survivors","Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial","LIFTING2","Inclusion Criteria:\n\n* males and females, 18 years of age and older\n* any head and neck cancer subtype, stage, and treatment type\n* at least 1-year posttreatment with adequate shoulder range of motion (must meet minimum cutpoints for active flexion and abduction to be eligible)\n* no unmanaged medical conditions, alcohol, or drug abuse\n* approved for exercise by oncologist and a certified exercise physiologist or kinesiologist\n* ability to understand and communicate in English\n\nExclusion Criteria:\n\n* has met the Canadian Physical Activity strength training guidelines within the past one-month: at least two days per week of muscle and bone strength training activities using major muscle groups\n* currently involved in a different exercise trial or clinical drug trial",{"count":166,"type":22},[26],"Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS.",[33,143,259,489],[517,518,444,410],"Strength Training","Exercise","2026-02-04",{"date":521,"type":71},"2026-02-09",{"date":523,"type":71},"2025-02-17",{"date":525,"type":22},"2026-06",{"name":527,"class":155},"University of Alberta",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":543,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":92},"100610295","access-to-care-pilot-for-ed-presenting-head-and-neck-cancer-patients-enrich-hnc-100610295","NCT07225725","Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)","Community Health Support for Emergency Department-Presenting Head and Neck Cancer Patients: A Pilot to Improve Access to Timely Care","ENRICH-HNC","Inclusion Criteria\n\n* Age 18 years or older\n* Presentation to the emergency department (ED) with a new or suspected head and neck cancer (including oral cavity, oropharynx, hypopharynx, larynx, salivary gland, cutaneous, sinonasal, nasopharyngeal, thyroid, or metastatic disease with unknown primary)\n* Residence within the regional catchment area of participating UTHSC-affiliated hospitals (Methodist University Hospital or Regional One Health)\n* Ability to provide informed consent electronically using REDCap eConsent after ED discharge\n* Has a valid telephone number for post-discharge contact\n\nExclusion Criteria\n\n* Prior or ongoing established head and neck oncology care at the time of ED presentation\n* Currently receiving hospice or palliative-only care\n* Incarcerated individuals\n* Inability to complete electronic informed consent (e.g., lack of decisional capacity or inability to complete consent even with staff assistance)\n* Lacks reliable telephone access or is unable to be reached after three documented contact attempts by study staff\n* Non-English or non-Spanish speaking when interpreter services are unavailable\n* Expected survival less than four weeks, as determined by the treating clinical team",{"count":537,"type":22},24,[140],"Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face significant delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple socioeconomic and systems-level barriers to accessing timely cancer care. Delays of more than 30 days have been associated with worse outcomes, including higher recurrence rates and reduced survival.\n\nThis pilot study will evaluate the feasibility and early impact of a community-based navigation program designed to improve access to timely care for ED-presenting HNC patients. The study embeds trained Community Health Support Specialists (CHSS) from the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program into the ED-to-treatment pathway. After ED discharge, CHSS staff will contact participants by telephone or text message to identify barriers to care-such as transportation, insurance, housing, or communication challenges-and connect them with appropriate community or institutional resources.\n\nAll participants will receive the CHSS navigation intervention. Outcomes will be compared with a historical cohort of similar ED-presenting HNC patients treated prior to program implementation. The primary outcomes are time from ED discharge to diagnostic biopsy and time from ED discharge to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of participants who complete CHSS navigation, and exploratory analyses of the types of barriers identified and resolved.\n\nFindings from this pilot will generate preliminary data to inform larger studies aimed at improving access, reducing disparities, and accelerating treatment for head and neck cancer patients who first present in the emergency setting.",[33,541,542],"Emergency Department Presentation","Head and Neck Cancer (H&N)",[544,545,546,547,548,549,550,551,552,143],"Emergency Department","Patient Navigation","Community Health Support","Health Equity","Cancer Care Access","Care Timeliness","Implementation Science","Engaging Navigators to Reduce Inequities in Cancer Health","ENRICH Program","2026-01-20",{"date":555,"type":71},"2026-01-22",{"date":557,"type":22},"2026-02-01",{"date":559,"type":22},"2027-01-31",{"name":561,"class":155},"University of Tennessee",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":583,"locationsCount":156},"100447451","photobiomodulation-therapy-plus-m-health-in-head-and-neck-cancer-patients-laxer-study-100447451","NCT05106608","Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study","Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study","LAXER","Patients will be included in the study if they meet the following inclusion criteria:\n\n* men or women aged 18 years or older and were diagnosed with HNC.\n* chronic xerostomia.\n* received RT in the parotid, submandibular and\u002For sublingual salivary glands.\n* grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).\n* medical treatment completed and in complete remission.\n* received medical clearance for participation in this study.\n* at least one month passed since the end of RT to avoid the possible presence of oral mucositis and\u002For radiodermatitis, which limits adherence to treatment and maximum 36 months.\n* no history of drugs\u002Fdevices\u002Fproducts (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion.\n* and able to access mobile applications or living with someone who has this ability.\n\nThe exclusion criteria will be as follows:\n\n* patients with metastases.\n* a score \\\u003C60 on the Karnofsky Performance Status Scale.\n* contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy).\n* other comorbidities such as diabetes and polypharmacy.\n* and retraction of the declaration of consent.",{"count":166,"type":22},[140],"The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.",[143,33,409],[444,197,409,575,576],"Low-Level Light Therapy","Telemedicine","2025-12-30",{"date":579,"type":71},"2026-01-05",{"date":581,"type":71},"2022-07-13",{"date":302,"type":22},{"name":584,"class":155},"Universidad de Granada",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":18,"minAge":591,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":156},"100592794","phase-3-head-and-neck-cancer-study-project-in-the-geriatric-population-100592794","NCT06998069","Head and Neck Cancer Study Project in the Geriatric Population","Inclusion Criteria:\n\n* Patients must have the following\n* Pathology confirmed squamous cell carcinoma of the head and neck (unknown primary is excluded).\n* Confirmed stage of disease between IB and IVA, based on imaging studies.\n* CGA score of 3-5\n* Evaluation by medical oncology and radiation oncology.\n* Patients in the experimental group must be eligible for systemic treatment with chemoimmunotherapy followed by radiation treatment as determined by the geriatric oncology team.\n* Age ≥ 65 years.\n* ECOG performance status ≤ 2\n* Adequate organ and marrow function as defined below:\n\nAbsolute neutrophil count ≥1.0 x 109\u002FL Platelets \\>100,000\u002Fmm3 Total bilirubin \\\u003C1.5 x ULN Aspartate aminotransferase (ast\u002Fsgot) \\\u003C3 x ULN Alanine aminotransferase (alt\u002Fsgpt) \\\u003C3 x ULN Creatinine clearance ≥ 40 mL\u002Fmin as determined by Cockcroft Gault (using actual body weight) or \\\u003C1.5 x Upper limit of normal\n\nMales:\n\nCLcr (mL\u002Fmin) = \"\\[140 - age (years)\\] × weight (kg)\" \u002F\"72 × serum creatinine (mg\u002FdL)\"\n\nFemales:\n\n(CLcr (mL\u002Fmin) = \"\\[140 - age (years)\\] × weight (kg)\" \u002F\"72 × serum creatinine (mg\u002FdL)\" × 0.85\n\n* Patients receiving pembrolizumab must meet standard institutional criteria for immunotherapy including no history of severe autoimmune disease.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with metastases, including treated brain metastases, are not eligible for enrollment.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who have previously received systemic chemoimmunotherapy for H\u002FN cancer.\n* Patients with uncontrolled intercurrent illness.","65 Years",{"count":593,"type":22},20,[286],"This is a study conducted in patients with a diagnosis of stage IB-IVA squamous cell carcinoma of the head and neck. Patients will have a comprehensive geriatric assessment (CGA) as part of standard assessments. The patients classified as frail, with a CGA score of 3-5, will then be treated with a novel reduced intensity regimen. The regimen will be tailored based on the programmed cell death ligand 1 combined positive score (PD-L1 CPS) and will involve 4 cycles of systemic chemotherapy and\u002For immunotherapy followed by radiation treatment.",[33],[598,599],"Squamous cell carcinoma of the head and neck","Geriatric population","2025-12-28",{"date":577,"type":71},{"date":603,"type":71},"2025-08-27",{"date":605,"type":22},"2027-06-01",{"name":607,"class":155},"Brown University",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":156},"100586185","phase-1-dose-finding-study-of-zanzalintinib-with-pembrolizumab-and-cetuximab-in-head-and-neck-scc-100586185","NCT06912087","Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC","A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and\u002For Metastatic Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n* Histologically or cytologically confirmed recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC), which is considered incurable by local therapies.\n* Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible.\n* Age: Participants must be at least 18 years old.\n* ECOG Performance Status: Must be 0-1.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.\n* For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing.\n* Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R\u002FM disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy.\n* Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from any adverse events (AEs), including immune-related AEs from prior treatments.\n* Adequate organ and marrow function, including:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n* Platelets ≥ 100,000\u002Fmm3.\n* Hemoglobin ≥ 9 g\u002FdL.\n* Normal liver and kidney function.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Contraception: Sexually active fertile subjects must agree to use a highly effective method of contraception during the study and for 2 months after the last dose of cetuximab and 4 months after the last dose of pembrolizumab.\n\nExclusion Criteria:\n\n* Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors.\n* More than two prior lines of systemic therapy in the recurrent\u002Fmetastatic setting.\n* Relapsed disease within 3 months of definitive therapy.\n* Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment).\n* Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks.\n* Concomitant anticoagulation with oral anticoagulants or platelet inhibitors, unless on stable doses of acceptable anticoagulants.\n* Active infection requiring systemic treatment or significant cardiovascular, gastrointestinal, or other serious health issues that may affect study participation.\n* Known or suspected autoimmune disease, except for specific conditions like type I diabetes or controlled skin disorders.\n* Pregnancy or breastfeeding: Women must not be pregnant or breastfeeding at screening.\n* Other malignancies within the past 2 years (except for certain low-grade cancers like localized skin cancers).",{"count":616,"type":22},36,[25],"This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).",[33,34,620,621,622,623],"Neoplasm Recurrence, Local","Neoplasm Metastasis","Recurrent Squamous Cell Carcinoma","Metastatic Squamous Cell Carcinoma","2025-12-01",{"date":626,"type":71},"2025-12-02",{"date":628,"type":71},"2025-09-29",{"date":630,"type":22},"2027-06-05",{"name":272,"class":155},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":638,"enrollmentInfo":639,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":640,"conditions":641,"keywords":644,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":156},"100539387","nidcd-otolaryngology-clinical-protocol-biospecimen-bank-100539387","NCT06303180","NIDCD Otolaryngology Clinical Protocol Biospecimen Bank","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Ability to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.\n* Ability of subject (or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Have a hearing, balance, smell, taste, voice, speech or language condition for which the subject is under clinical care or research purposes under a separate Review Board (IRB) approved protocol; OR be a healthy volunteer aged at least 3 years, enrolled on an approved research protocol.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction\n* Have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the subjects risk in participating. This will be determined at the discretion of the principal investigator.","99 Years",{"count":103,"type":22},"Background:\n\nMany disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.\n\nObjective:\n\nTo collect biological samples for a repository that will be used for research.\n\nEligibility:\n\nPeople of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.\n\nDesign:\n\nPart 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.\n\nPart 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.\n\nParticipants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.\n\nSamples may be used for genetic testing.",[642,33,643,110],"Hearing Loss","Hearing Disorders",[645,646,647,648,649,114,112,115],"Hearing","Balance","Speech","Taste","SMELL","2025-11-13",{"date":652,"type":71},"2025-11-14",{"date":654,"type":71},"2024-03-04",{"date":656,"type":22},"2033-12-30",{"name":658,"class":127},"National Institute on Deafness and Other Communication Disorders (NIDCD)",{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":23,"phases":667,"briefSummary":669,"conditions":670,"keywords":673,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":681,"leadSponsor":683,"locationsCount":485},"100605103","phase-4-dpyd-pharmacogenomics-and-fluoropyrimidine-fp-dose-adjustment-100605103","NCT07158164","DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment","Inclusion Criteria:\n\n* Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine.\n* DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Clinic or other certified laboratory) with results available before starting chemotherapy.\n* DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine:\n* Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).\n* Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose.\n\n  --FOLFOX regimen (N=50)\n* ECOG Performance Status 0-2.\n* Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens.\n\nExclusion Criteria:\n\n* Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of the treating physician.\n* Patients with two DPYD variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) should not receive 5-FU or Capecitabine and are therefore excluded from the study.\n* Pregnant Women and Children",{"count":666,"type":22},100,[668],"PHASE4","To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.",[203,671,33,672],"Breast Neoplasms","Gastro-Intestinal Intraepithelial Neoplasia",[674,675,263,676,677],"colorectal cancer","breast cancer","Gastro-Intestinal cancer","chemotherapy toxicity","2025-11-11",{"date":650,"type":71},{"date":603,"type":71},{"date":682,"type":22},"2029-07-07",{"name":684,"class":155},"Rutgers, The State University of New Jersey",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":23,"phases":694,"briefSummary":695,"conditions":696,"keywords":705,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":716,"locationsCount":593},"100395472","phase-1-study-of-safety-and-tolerability-of-bca101-monotherapy-and-in-combination-therapy-in-patients-with-egfr-driven-advanced-solid-tumors-100395472","NCT04429542","Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors","First-in-Human, Phase 1\u002F1b, Open-label, Multicenter Study of Bifunctional EGFR\u002FTGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors","Inclusion Criteria:\n\n* Patient must have measurable disease amendable to biopsy and be willing to undergo both a pre-treatment and on-treatment biopsy, as well as provide archival tumor if available from the primary tumor (a paraffin embedded tumor tissue block sufficient to obtain at least 10 sections of 4 to 5 micrometer thickness).\n* Patient must have a performance status of ≤1 on the Eastern Cooperative Oncology Group Performance Scale.\n* Patients must have evaluable or measurable disease (computed tomography \\[CT\\]\u002Fmagnetic resonance imaging \\[MRI\\] scans performed within 21 days before the screening visit are acceptable) demonstrating measurable disease, i.e., at least 1 unidimensional measurable lesion as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST).\n* Tumor eligibility:\n\nPART B (Cohort expansion):\n\n1. Single agent BCA101 - patients with the following tumor type will be eligible:\n\n   • Expansion Cohort 1: Cutaneous Squamous Cell Carcinoma (CSCC) - i. patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting.\n\n   ii. No prior history of treatment with anti-EGFR antibodies in the unresectable\u002Fmetastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).\n2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:\n\n   • Expansion Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test. Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).\n\n   i. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed \\>6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (\\>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).\n\n   ii. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.\n\n   iii. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer\n   * Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced\u002Funresectable or metastatic.\n\n     i. Patients must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy and received no more than 2 prior lines of systemic treatments for treatment of unresectable and\u002For metastatic disease. No prior history of immune checkpoint inhibitors.\n   * Expansion Cohort 5: Squamous Non-Small Cell Lung Cancer (SqNSCLC) i. Patients must have a histologically or cytologically confirmed diagnosis of stage IV (AJCC 8th edition) squamous NSCLC. Patients with mixed histology (e.g., adenosquamous) are not allowed.\n\n   ii. Patients must have progressed on one prior systemic therapy in the metastatic setting.\n\n   iii. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.\n\n   • Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.\n3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab • Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.\n\nExclusion Criteria:\n\n* For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of study drug.\n* Prior treatment with any anti-TGFβ therapy.\n* Prior history of Grade ≥ 2 intolerance or hypersensitivity reaction to cetuximab or other anti-EGFR therapy or other murine proteins or prior discontinuation of therapy in the setting of toxicity related to treatment.\n* Pregnant or breastfeeding women.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study drug, with the exception of topical, intranasal, intrabronchial, or ocular steroids.\n* Known history of a hematologic malignancy (or solid tumor other than the ones indicated for this study), unless the patient has undergone potentially curative therapy with no evidence of that disease for 2 years. Does not include tumors with a negligible risk of metastasis or death (e.g. adequately treated basal or squamous cell carcinoma, stage 1 prostate cancer, or carcinoma in situ of the cervix or carcinoma in situ of the breast). Subjects enrolling in the CSCC cohort may have chronic lymphocytic leukemia as long as the patient is not on active treatment.\n* Known cases of human immunodeficiency virus (HIV) are excluded if patients have a CD4+ T-cell (CD4+) count \\\u003C250 cells\u002FuL. To ensure that effective antiretroviral therapy (ART) is tolerated and that toxicities are not confused with investigational drug toxicities, trial participants should be on established ART for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment.\n* Patients with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment\n* Patients with a known history of hepatitis C who have not completed curative antiviral treatment or have a HCV viral load above the limit of quantification",{"count":693,"type":22},292,[25],"The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.",[259,697,698,699,700,701,702,703,33,34,704],"Squamous Cell Carcinoma of Anal Canal","Colorectal Cancer","Squamous Cell Carcinoma of the Lung","EGFR Amplification","Epithelial Ovarian Cancer","Pancreas Cancer","Cutaneous Squamous Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck",[706,707,708,709],"TGFβ","EGFR","pembrolizumab","ficerafusp alfa","2025-08-14",{"date":712,"type":71},"2025-08-15",{"date":714,"type":71},"2020-06-01",{"date":605,"type":22},{"name":717,"class":78},"Bicara Therapeutics",{"id":719,"slug":720,"hasResults":12,"nctId":721,"briefTitle":722,"officialTitle":723,"acronym":4,"eligibilityCriteria":724,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":725,"targetDuration":4,"studyType":23,"phases":727,"briefSummary":728,"conditions":729,"keywords":740,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":746,"lastUpdatePostDateStruct":747,"startDateStruct":749,"completionDateStruct":751,"leadSponsor":753,"locationsCount":755},"100511807","phase-1-htl0039732-in-participants-with-advanced-solid-tumours-100511807","NCT05944237","HTL0039732 in Participants With Advanced Solid Tumours","A Cancer Research UK Phase I\u002FIIa Trial of HTL0039732, Given Orally as Monotherapy and in Combination With Immunotherapy or Other Approved Therapies in Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product administration and follow-up.\n2. Phase 1, dose escalation phase\n\n   Part A (HTL0039732 monotherapy):\n   * Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the potential participant.\n   * At least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy, or at least one assessable lesion e.g. pleural or peritoneal thickening that does not fulfil RECIST v1.1 criteria for measurable disease.\n\n     a. Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n   * Consent to access and analysis of any available archival tissue or a fresh tumour sample at baseline, if archival tissue is unavailable.\n   * Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n\n   Phase 1 Part B:\n\n   \\- Histologically proven advanced solid tumour where PGE2\u002FEP4 signalling is believed to be more prevalent or significant (such as microsatellite stable colorectal cancer (MSS CRC), gastro-esophageal cancer, head and neck squamous cell carcinoma (HNSCC), mCRPC, pancreatic cancer, lung cancer, bladder cancer, mesothelioma, cervical cancer, renal cancer, sarcoma, pheochromocytoma and cancers with PI3K\u002FAKT\u002FmTOR pathway activating mutations using a clinically-validated assay).\n\n   Phase 2a:\n\n   \\- Histologically proven advanced solid tumour, in line with indications listed below, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the potential participant:\n   1. MSS CRC with PIK3CA or HER2 mutation, and\u002For other driver mutation as agreed with the Sponsor (genomic alteration to have been previously identified using a validated next-generation sequencing method performed on either tumour tissue or circulating tumour DNA \\[ctDNA\\]);\n   2. Gastric or gastroesophageal junction (GOJ) adenocarcinoma;\n   3. Clear cell renal cell carcinoma;\n   4. mCRPC\n\n   Phase 1 Part B and Phase 2a:\n   * Consent to access and analysis of any available archival tissue.\n   * Consent for fresh tumour biopsy samples at baseline and on treatment. However, the following exceptions will be permitted if archival tissue is available at the recruiting site:\n\n     1. Patients with mCRPC: biopsies are not required for those whose only safely accessible lesions are bone metastases that lack an accessible soft tissue component.\n     2. For the first 12 participants in each indication: the on-trial biopsy is optional; and the baseline biopsy is mandatory if there is a safely accessible lesion but may be omitted for patients who have no safely accessible lesion, to permit their inclusion in the study. This will continually be assessed through the study.\n   * Disease refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the participant.\n   * Except for mCRPC, at least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy. Potential participants with mCRPC may instead have had PD according to PCWG3 criteria.\n\n     1. Previously irradiated lesions cannot be counted as target lesions unless clearly progressed after the radiotherapy.\n     2. Lesions that are intended to be biopsied should not be counted as target lesions (those undergoing biopsy must have at least one target lesion that is not intended to be biopsied).\n   * For indications where anti-PD-1\u002FPD-L1 therapy is standard of care (such as clear cell renal cell carcinoma, or gastric or GOJ adenocarcinoma with elevated PD-L1 expression), patients must have received that therapy and must be considered to have had progressive disease by the Investigator either on, or within 6 months after, that treatment.\n3. Life expectancy of at least 12 weeks.\n4. Eastern Cooperative Oncology Group performance status of 0 or 1.\n5. Haematological and biochemical indices within the protocol specified ranges.\n6. Stable thyroid function tests. Stable doses of thyroxine replacement are permitted.\n7. Aged 18 years or over at the time consent is given.\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative reasons), chemotherapy, non chemotherapy systemic anti-cancer therapy (apart from life-long hormone suppression such as luteinising hormone-releasing agents in participants with mCRPC) or investigational medicinal products during the 4 weeks prior to enrolment; or first dose of an immunotherapy during the previous 12 weeks before first dose of HTL0039732.\n2. Ongoing toxic manifestations of previous treatments that are Grade \\>1 per CTCAE v5.0.\n3. Any central nervous system metastases (unless potential participants have had local therapy and are asymptomatic, radiologically stable and have been off steroids for ≥4 weeks prior to enrolment).\n4. Women of child-bearing potential (or who are already pregnant or lactating). Exceptions apply.\n5. Men with partners of childbearing potential. Exceptions apply.\n6. Major thoracic or abdominal surgery from which the potential participant has not yet recovered.\n7. At high medical risk because of non-malignant systemic disease, including active uncontrolled infection.\n8. Known history of current or latent tuberculosis, HIV or Hepatitis B or C infection.\n9. Prior treatment with EP4 inhibitor.\n10. Treatment with selective cyclooxygenase-2 inhibitor in the 8 weeks prior to enrolment.\n11. Known hypersensitivity or intolerance to hydroxypropyl methylcellulose.\n12. Use of systemic immunosuppressive agent in the 2 weeks prior to enrolment. Exceptions apply.\n13. Significant cardiovascular disease.\n14. Known active peptic ulcer disease, or symptoms of gastritis, dyspepsia or gastro-esophageal reflux disease (one or more episodes per week).\n15. Current or planned participation in another interventional clinical trial, whilst taking part in this trial of HTL0039732.\n16. Limited ability to swallow or absorb oral medications.\n17. Any other condition that, in the Investigator's opinion, would mean that the trial is not in the best interests of the potential participant.\n\n    Phase 1 Part B and Phase 2a:\n18. Any live vaccines in the 4 weeks prior to enrolment.\n19. Diagnosis of immunodeficiency.\n20. Active autoimmune disease requiring systemic treatment in the 2 years prior to enrolment.\n21. History or clinical suspicion of interstitial lung disease, history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n22. Hypersensitivity to atezolizumab or any of its excipients.\n23. Prior adverse reaction to cancer immunotherapy that required steroid or other immunosuppressive treatment or led to discontinuation of that treatment.",{"count":726,"type":22},150,[25,26],"The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.",[197,730,731,732,33,203,202,733,734,735,736,737,738,739],"Prostatic Neoplasms, Castration-Resistant","Stomach Neoplasms","Esophageal Neoplasms","Lung Neoplasms","Urinary Bladder Neoplasms","Mesothelioma, Malignant","Uterine Cervical Neoplasms","Kidney Neoplasms","Sarcoma","Pheochromocytomas",[741,742,743,744,745],"EP4 antagonist","Anti-PD-1\u002FPD-L1 agents","PGE2","EP4","COX inhibitor","2025-06-05",{"date":748,"type":71},"2025-06-08",{"date":750,"type":71},"2023-07-13",{"date":752,"type":22},"2027-06",{"name":754,"class":155},"Cancer Research UK",5]