[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,45,69,99,128,161,181,213,245,289,320,367,396,424,457,475,509,533,561,589,619,657,688,707,727],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100639699","phase-1-combining-neo-adjuvant-atr-inhibition-with-nodal-sbrt-for-early-stage-resectable-hpv-opsccs-100639699",false,"NCT07578467","Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","A Phase Ib\u002FII Study Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","Inclusion Criteria:\n\n* Age ≥ 18\n* Patients that have been diagnosed with HPV-positive throat cancer (OPSCC) at an early stage (stage I or II), confirmed by a biopsy.\n* Patients' blood calcium level is within a safe range\n* Patients' blood, kidney, and liver health are strong enough, shown through specific medical test results\n* If a participant is female, she must not be pregnant or breastfeeding.\n* If a participant is male, he must agree to use highly effective birth control from the start of the study until a short period after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients with late-stage tumors (Stage III or IV)\n* If the cancer has already spread to distant parts of the body (M1) when first diagnosed\n* Prior advanced head and neck cancer requiring radiation or major surgery\n* Patients whose original tumor site cannot be identified\n* Patients that have a known additional malignancy that is progressing or requires active treatment\n* Patients that had a surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119. This does not include procedures that are used to diagnose or determine extent of study disease (such as biopsies).\n* Patients taking medications that strongly affect how the body processes certain drugs (CYP enzymes) at the same time as the study treatment.\n* Patients with active infections and\u002For receiving systemic antibiotics or anti-viral medications.\n* Patients with uncontrolled HIV or active hepatitis B or C are usually not eligible. However, those whose infections are well-controlled on treatment for at least a month and meet certain viral load limits can participate\n* Current or past diagnosis of leukemia within the past 5 years.\n* Patients with a history of non-malignant gastrointestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.\n* Patient has uncontrolled hypertension at time of enrollment.\n* Patients who recently had serious kidney problems or kidney disease.\n* Patients cannot have taken another experimental drug within 30 days-or within a period equal to five times that drug's half-life-before starting this study\n* Medical illness that, in the opinion of the Investigator, may impact the safety of the patient\n* Patients who use recreational drugs or have mental health conditions that might make it hard to follow study visits, based on the doctor's judgment.\n* Known hypersensitivity to ATRN-119 or its ingredients\n* Patients with serious liver disease or liver problems that could affect how the body processes the study drug\n* Patients who are fairly limited in daily activities (ECOG score of 2 or higher)\n* Patients with serious other health problems that the doctor thinks could prevent them from completing the study\n* Pregnancy or lactation\n* Inability to provide informed consent","ALL","18 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This research study is testing whether a new study drug (called ATRN-119) is safe and effective when combined with a single, highly targeted dose of radiation therapy (called stereotactic body radiation therapy or SBRT) to treat early-stage throat cancer that is caused by HPV.\n\nThe goal of this study is to treat cancer effectively while reducing side effects and helping patients maintain a better quality of life over the long term. Researchers hope that this approach will be just as successful-or possibly more successful-than current treatments, which already have high cure rates.\n\nParticipants will:\n\n* Take 800mg of ATRN-119 every day for 10 days\n* Receive 1 treatment (called a \"fraction\") of SBRT to the neck on day 3 of ATRN-119 dosing.\n* Keep a short diary to track ATRN-119 dosing. The diary will be provided by study team\n* Receive standard of care treatment after treatment with ATRN-119 + SBRT including TransOral Robotic Surgery (TORS) to remove the primary tumor with Neck Dissection and adjuvant therapy (if indicated)\n* Receive additional safety checkups and tests by researchers during routine visits with their cancer doctor for 2 years after study treatment",[28,29,30,31,32],"HPV Positive Oropharyngeal Squamous Cell Carcinoma","Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","HPV Associated Cancers","Oropharyngeal HPV Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":21},"2026-05-31",{"date":41,"type":21},"2030-05-31",{"name":43,"class":44},"Abramson Cancer Center at Penn Medicine","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100632415","phase-2-omission-of-postoperative-radiation-in-hpv-associated-oropharyngeal-cancer-using-cthpvdna-surveillance-operation-100632415","NCT07513389","Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)","Omission of Immediate Postoperative Radiation in Patients With Intermediate Pathological Risk Features and Negative Two-Week Post-Operative ctHPVDNA (OPERATION Trial)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, ≥ 18 years of age (no upper age limit).\n* Biopsy proven squamous cell carcinoma.\n* p16 positive (diffuse ≥ 70% tumor cell expression, with at least moderate (2\u002F3+ staining intensity).\n* NavDx positive, HPV16 TTMV only.\n* AJCC 8th edition cT0-2 N1 M0.\n* Well lateralized tonsil (\\>1 cm from midline, tonsil, base of tongue, glossotonsillar sulcus primary tumors.\n* ≤ 2 lymph nodes, each ≤ 3cm, -OR- 1 lymph node \\>3 but \\\u003C 6 cm.\n* ≤10 pack-years of cigarette smoking or no cigarette smoking for ≥ 5 years (regardless of pack years).\n* Anatomically (e.g. adequate exposure) and physically amenable to TORS per the judgement of the operating surgeon.\n* Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to surgery; at a minimum CT imaging of the chest. PET\u002FCT is acceptable.\n* ECOG Performance Status 0-1.\n* CBC with differential obtained within 8 weeks prior to surgery, with adequate bone marrow function defined as follows:\n\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g\u002Fdl is acceptable. Transfusion must be completed within 2 to 4 weeks prior to enrollment.)\n* Adequate renal and hepatic function within 8 weeks prior to surgery, defined as follows:\n\n  * Serum creatinine \\\u003C 2.0 mg\u002Fdl.\n  * Total bilirubin ≤ 1.5 x the institutional ULN.\n* Negative pregnancy test within 2 weeks prior to surgery for women of childbearing potential.\n* Eligible for platinum chemotherapy. Chemotherapy drugs allowed: cisplatin, carboplatin\u002Fpaclitaxel, carboplatin\u002Fabraxane, per treating physician (cisplatin preferred, 2nd preference carboplatin\u002Fpaclitaxel or carboplatin\u002Fabraxane).\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional year after surgery per MD discretion. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and\u002For implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).\n\nExclusion Criteria:\n\n* Prior history of surgery to the head and neck that in the opinion of the investigators would modify prognostic significance of pathology results.\n* Prior history of radiation therapy to the head and neck, with the exception of skin cancer treated with a small (≤ 9cm3) field with 6 - 9 MeV electron beam or 50 - 250 kVp photon beam.\n* Prior history within 5 years of cancer with the exception of:\n\n  * Basal cell carcinoma of the skin\n  * Squamous cell carcinoma of the skin, stage 1-2\n  * Prostate cancer without distant metastases (stage M0)\n  * Thyroid cancer without distant metastases (stage M0)\n* Prior history of squamous cell carcinoma of a mucosal site in the head or neck treated with surgery alone.\n* Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.\n* Current smoker or tobacco user.\n\n  * Severe, active co-morbidity, defined as one or more of the following:\n  * Unstable angina and\u002For congestive heart failure requiring inpatient 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 (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n\n    \\--- Note, however, coagulation parameters are not required for entry into this protocol.\n  * Evidence of active systemic lupus or scleroderma.\n  * Psoriatic arthritis.\n* Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population.\n\n  \\-- Note: HIV testing at the time of enrollment is not required.\n* Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for the immediate post-op period (1-2 weeks). Females will be determined to be not of child-bearing potential with a history of hysterectomy or with postmenopausal status of \\>12 months.\n* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting one month prior to screening and for one year after surgery per MD discretion.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.",{"count":53,"type":21},36,[25],"This single-arm Phase II trial evaluates whether omission of postoperative radiotherapy is feasible and oncologically safe in select patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). Eligible patients undergo transoral robotic surgery (TORS) and are observed without adjuvant radiation if they demonstrate low or intermediate pathological risk features and have negative circulating tumor HPV DNA (ctHPVDNA) two weeks post-operatively. Patients are followed with standard clinical surveillance combined with serial ctHPVDNA testing (NavDx®) to facilitate early detection of recurrence and prompt salvage therapy as needed.",[29,57,58],"Human Papilloma Virus (HPV)","Oropharyngeal Squamous Cell Carcinoma (OPSCC)","RECRUITING","2026-06-29",{"date":34,"type":37},{"date":63,"type":21},"2026-10-01",{"date":65,"type":21},"2030-07-01",{"name":67,"class":44},"Medical University of South Carolina",1,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":68},"100611515","vitamin-d-effects-on-immune-microenvironment-of-nonmelanoma-skin-cancer-after-photodynamic-therapy-pdt-100611515","NCT07241585","Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)","Inclusion Criteria:\n\n* Must be an adult participant (\\> 18 yrs) who is scheduled to undergo Mohs surgery or ED\\&C within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic.\n* Must have at least one BCC or SCC tumor eligible for removal by Mohs surgery.\n* The original tumor size prior to biopsy must be \\>1.0 cm (in the longest diameter).\n* Participants of any ethnic group are eligible for this trial.\n* Must provide informed consent to participate in the trial.\n* Participant must live in Ohio (Groups 2 \\& 3), because Research Pharmacy cannot ship the study drugs outside of the state.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Currently being treated for other cancers with medical or radiation therapy\n* Known hypersensitivity to 5-aminolevulinic acid\n* History of a photosensitivity disease, e.g., porphyria cutanea tarda",{"count":76,"type":21},54,[78],"NA","This research study is for people who have been diagnosed with a nonmelanoma skin cancer (either basal cell carcinoma or squamous cell carcinoma) and are planning to receive either Mohs surgery or ED\\&C (electrodessication \\& curettage) as part of clinical care. The purpose of this study is to understand how photodynamic therapy (PDT) with or without Vitamin D can promote an immune response to skin cancer.\n\nFor this study, participants will be randomized (randomly assigned) and asked to take Vitamin D or placebo for 6 days and come to the clinic for a single PDT treatment 1-14 days prior to their surgery. At this visit, photographs of participant's skin cancer will be taken, and participants will undergo PDT treatment. The study team will also take photos on the day of Mohs surgery or ED\\&C. There will be up to two blood draws for research.\n\nIf participants do not want to come in for a PDT treatment prior to their Mohs surgery or ED\\&C, they will have the option to participate by only allowing the study team to collect data about their skin cancer and their tissue from Mohs surgery or ED\\&C.",[81,82,29],"Nonmelanoma Skin Cancer","Basal Cell Carcinoma",[84,85,86,87,88,89],"Mohs surgery","Electrodessication & curettage","ED&C","Photodynamic therapy","PDT","Vitamin D","2026-06-17",{"date":92,"type":37},"2026-06-18",{"date":94,"type":37},"2026-02-25",{"date":96,"type":21},"2027-08",{"name":98,"class":44},"Case Comprehensive Cancer Center",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100563397","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-scc-for-immunocompromised-patients-100563397","NCT06615635","Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients","A Pivotal, Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma","DaRT","Inclusion Criteria:\n\n* 1\\. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.\n\n  4\\. Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye) as decided by treating physician and sponsor.\n\n  8\\. Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male\u002F female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 1 year after the DaRT insertion visit.\n\n  14\\. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.\n\n  15\\. Blood tests values:\n  * Platelets ≥100,000 mm3,\n  * Total bilirubin ≤ 1.5xULN,\n  * AST ≤2.5xULN,\n  * SGOT ≤2.5xULN,\n  * SGPT ≤2.5xULN,\n  * Alkaline Phosphatase ≤2.5xULN.\n  * Creatinine Clearance ≥30 ml\u002Fmin.\n  * INR or Prothrombin time ≤1.5xULN.\n\nExclusion Criteria:\n\n* 1\\. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).\n\n  2\\. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. Patients receiving any of the following within 4 weeks of enrollment:\n  1. Antineoplastic systemic chemotherapy or biological therapy\n  2. Immunotherapy\n  3. Investigational agents other than the study intervention\n  4. Radiation therapy\n  5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.\n\n     10\\. Longest tumor diameter \\>7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.\n\n     14\\. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.\n\n     15\\. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and\u002For interpretation of treatment safety or effectiveness.\n\n     16\\. High probability of protocol non-compliance (in opinion of investigator). 17. Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n\n     18\\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n\n     19\\. Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 1 year after the DaRT insertion visit.\n\n     20\\. Breastfeeding or pregnant women 21. Tattoos scars, body jewelry (e.g., nose rings) or other identifying marks which cannot be adequately hidden on digital photos or other identifying marks which cannot be adequately hidden on digital photos",{"count":108,"type":21},28,[78],"This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:\n\n1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.\n2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.\n3. Assess Local control up to 12 months after DaRT insertion.",[29,112,113,114,115,116],"Alpha Radiation","Immunocompromised","Carcinoma, Squamous","Skin Cancer","Brachytherapy","2026-06-15",{"date":119,"type":37},"2026-06-16",{"date":121,"type":37},"2026-01-01",{"date":123,"type":21},"2026-12",{"name":125,"class":126},"Alpha Tau Medical LTD.","INDUSTRY",11,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":146,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":68},"100447298","spectroscopic-analysis-of-tongue-tumor-samples-100447298","NCT05104619","Spectroscopic Analysis of Tongue Tumor Samples.","Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy","SpecTum","Inclusion Criteria:\n\n* age : 18 years and older\n* squamous cell carcinoma of the tongue\n* surgical resection as first-line treatment\n* tumor classification T1 to T4.\n\nExclusion Criteria:\n\n* metastatic disease\n* neoadjuvant therapies",{"count":137,"type":21},33,"OBSERVATIONAL","In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.\n\nTechniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.\n\nBased on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.",[141,142,143,29,144,145],"Mass Spectroscopy","Molecular Profile","Surgical Margins","Oral Cavity","Tongue",[147,148,149,150,151,152],"mass spectroscopy","molecular profile","surgical margins","squamous cell carcinoma","oral cavity","tongue","2026-06-12",{"date":117,"type":37},{"date":156,"type":37},"2021-03-10",{"date":158,"type":21},"2026-10",{"name":160,"class":44},"Centre Hospitalier Universitaire, Amiens",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":68},"100642363","phase-1-phase-1-study-of-trop2-caril-15-tgfbr2-ko-nk-cell-in-patients-with-oral-premalignant-lesions-100642363","NCT07631013","Phase 1 Study Of TROP2 CAR\u002FIL-15 TGFBR2 KO NK Cell In Patients With Oral Premalignant Lesions","Phase 1 Dose Escalation And Expansion Study Of Intralesional TROP2-CAR\u002F IL15 TGFBR2 KO Engineered Cord Blood-Derived NK Cells In Patients With Diffused Or Multifocal Oral Premalignant Lesions","Inclusion Criteria:\n\n1. Subjects with diffuse or multifocal oral premalignant lesions are eligible for this study and must have a confirmed histologic diagnosis of oral epithelial dysplasia or oral intraepithelial neoplasia. Diffuse disease is defined as a single lesion measuring 2 cm in greatest dimension, and multifocal disease is defined as the presence of two or more spatially distinct premalignant lesions within the oral cavity. Patients with a history of histologically confirmed head and neck squamous cell carcinoma, including oral cavity squamous cell carcinoma, are eligible provided there is no evidence of active invasive malignancy at the time of enrollment. For patients without a prior history of oral cavity squamous cell carcinoma, eligible lesions must demonstrate high-risk histology, including moderate dysplasia, severe dysplasia, or carcinoma in situ; in patients with a prior history of oral cavity squamous cell carcinoma, dysplasia of any grade identified on prior resection specimens or surveillance biopsies is acceptable. Histologic evidence of oral epithelial dysplasia identified on prior oral cancer resection specimens or surveillance biopsies is acceptable. A visible, clinically measurable oral lesion, such as leukoplakia, erythroplakia, or other clinically apparent premalignant mucosal abnormality, must be present and accessible for intralesional injection and clinical assessment.\n2. Age ≥18 years\n3. Patient tumors must demonstrate TROP2 expression of 1+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories\n4. ≥2 weeks from the last cytotoxic chemotherapy, ≥3 days from last TKI or other targeted therapies, and ≥3 months from any cell therapy for any malignancy at the time of consent.\n5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Life expectancy ≥3 months per PI or treating physician's discretion.\n7. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 72 hours prior to initiation of lymphodepleting chemotherapy. If the urine pregnancy test cannot be confirmed as negative, a serum β-hCG test must be performed and must be negative prior to treatment initiation.\n\n   1. A WOCBP is defined (in Appendix 1) as a female who has experienced menarche (as early as 8 years of age) and has not undergone successful surgical sterilization or is not postmenopausal (defined as ≥12 consecutive months of amenorrhea without an alternative medical cause). Women will be considered not of childbearing potential if they have undergone hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation, or other permanent sterilization procedures, or have ovarian failure with follicle-stimulating hormone (FSH) and estradiol levels in the menopausal range, including those who have received whole pelvic radiation therapy. Due to the unknown effects of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell therapy on a developing fetus, and because radiation therapy is contraindicated during pregnancy, women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception prior to study entry, for the duration of study participation, and for 6 months following TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell injection. Acceptable methods of contraception include hormonal contraceptives (oral, injectable, implantable, transdermal, or vaginal ring), intrauterine devices (IUDs), surgical sterilization (tubal ligation or hysterectomy), partner vasectomy, or barrier methods (e.g., condoms) used with spermicide. Complete abstinence is acceptable if consistent with the participant's lifestyle; however, periodic abstinence, the rhythm method, and withdrawal are not acceptable.\n   2. Participants must agree to notify the treating physician immediately if pregnancy is suspected or confirmed during the study. Male participants must also notify the investigator if they father a child during the study period.\n8. Male patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 1 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell injection.\n9. Patients must have measurable disease as defined above in 4.1.1. Patients must have adequate organ function as defined below Table 1. Adequate Organ Function Laboratory Values Systemic Function Test Laboratory Value Hematologic ANC ≥1500\u002FµL Platelets ≥100,000\u002FµL Hemoglobin ≥9.0 g\u002FdLa Renal Creatinine ≤1.5 × ULNb OR CrCl by Cockcroft-Gault ≥45 mL\u002Fmin for patients with creatinine formula \\>1.5 × ULNb Hepatic Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\>1.5 × ULN AST and ALT ≤2.5 × ULN (≤5 × ULN for patients with liver metastases) Coagulation PT\u002FINR ≤1.5 × ULN unless patient is receiving aPTT anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT=alanine aminotransferase; ANC=absolute neutrophil count; aPTT=activated partial thromboplastin time; AST=aspartate aminotransferase; CrCl=creatinine clearance; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal.\n\n   1. Criteria must be met without erythropoietin dependency (and without packed red blood cell transfusion within last 2 weeks of the screening test) defined as an initiation or dose increase within 12 weeks prior to screening.Patients on a stable dose for \\>\u002F= 12 weeks are permitted...\n   2. Serum creatinine and CrCl should be interpreted and calculated per institutional standard.\n10. Left ventricular ejection fraction \\>50%.\n11. Adequate respiratory reserve defined as dyspnea Grade 0 or 1 and saturated oxygen \\>92% in room air. See Table 2 for a grading scale of dyspnea per the CTCAE v6.0.\n\n    Table 2. Dyspnea grading scale. Grade 0 - No shortness of breath Grade 1 - Shortness of breath with moderate exertion Grade 2 - Shorness of breath with minimal exertion; limiting instrumental ADL Grade 3 - Shortness of breath at rest; liniting self-care ADL Grade 4 - Life-threatening consequences; urgent intervention indicated Grade 5 - Death\n12. Prior treatment with TROP2-targeted therapy will be allowed.\n13. Willing to undergo mandatory blood collections and biopsies as required by the study.\n14. Willing to sign consent for long-term follow-up on protocol PA17-0483.\n15. Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell injection.\n16. 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.\n17. 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.\n18. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months post TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell injection.\n2. Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline.\n3. Patients with ≤Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the principal investigator (PI)\u002Fco-PIs. If a patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the start of lymphodepleting chemotherapy.\n4. If patients receive RT within 2 weeks of the start of treatment, they must not require corticosteroids and must not have had radiation pneumonitis. Of note, patients with prior RT to the esophagus or with RT plans predicted to expose the esophagus to RT are excluded.\n5. Has received a live vaccine within 6 weeks prior to TROP2 CAR\u002FIL-15 TGFBR2 KO NK injection and agrees to not receive live vaccine for at least 24 months post-injection. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n6. Prior CAR T or NK cell or other genetically modified T or NK cell therapy.\n7. Receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent).\n8. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate if they completed radiation therapy, are clinically stable, and without requirement of steroid treatment for at least 2 weeks prior to study enrollment.\n9. History of interstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD.\n10. Active infection requiring systemic therapy.\n11. Known human immunodeficiency virus (HIV) infection.\n12. Known active or chronic hepatitis B or hepatitis C virus infection.\n13. Known history of active tuberculosis (Mycobacterium tuberculosis).\n14. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n15. Clinically significant cardiovascular disease within 12 months prior to the start of lymphodepleting chemotherapy, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular event, or cardiac arrhythmia associated with hemodynamic instability. NOTE: medically controlled arrhythmia would be permitted.\n16. Patients with bleeding or thrombotic disorders or at risk for severe hemorrhage. Patients with known deep vein thrombosis\u002Fpulmonary embolism who are on appropriate anticoagulation treatment are eligible.\n17. Patients with a history of ≥Grade 3 stomatitis or mucositis with prior therapy.",{"count":53,"type":21},[24],"This is a phase 1, single-arm, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of TGFBR2 TROP2 CAR\u002FIL15 NK cells in patients with high-risk oral premalignant lesions.",[29],"2026-06-09",{"date":174,"type":37},"2026-06-11",{"date":176,"type":21},"2026-12-31",{"date":178,"type":21},"2030-06-30",{"name":180,"class":44},"M.D. Anderson Cancer Center",{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":68},"100219375","phase-2-t-cell-receptor-immunotherapy-for-patients-with-metastatic-non-small-cell-lung-cancer-100219375","NCT02133196","T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer","A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen","* INCLUSION CRITERIA:\n\n  1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.)\n  2. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n  3. All patients must have had at least one appropriate first line systemic therapy and progressed.\n  4. Clinical performance status of ECOG 0 or 1.\n  5. Age \\>= 18 years of age and \\\u003C= 72 years of age.\n  6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child.\n  7. Willing to sign a durable power of attorney\n  8. Able to understand and sign the Informed Consent Document\n\nI. Hematology:\n\n* Absolute neutrophil count \\> 1000\u002Fmm\\^3 without support of filgrastim\n* Normal WBC (\\>= 2500\u002Fmm\\^3).\n* Hemoglobin \\> 8.0 g\u002Fdl. Subjects may be transfused to reach this cut-off.\n* Platelet count \\>= 80,000\u002Fmm\\^3\n\n  j. Serology:\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  k. Chemistry:\n* Serum ALT\u002FAST \\\u003C= 2.5 times the upper limit of normal.\n* Serum creatinine \\\u003C= 1.6 mg\u002Fdl.\n* Total bilirubin \\\u003C= 2 mg\u002Fdl, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C= 3 mg\u002Fdl.\n\n  l. IOCBP must have a negative pregnancy test or evidence that they are not pregnant (e.g., ultrasound or serial HCG measurements) prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\n  m. Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks, as long as related major organ toxicities have recovered to grade 1 or less.\n\nn. More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient's toxicities must have recovered to a grade 1 or less.\n\no. Subjects must be co-enrolled in protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.\n2. Ongoing need for pharmacological immunosuppression, including steroids\n3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses\n4. Major bronchial occlusion or bleeding not amenable to palliation.\n5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency\n\n   Disease and AIDS).\n6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \\\u003C= 45%.\n9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \\\u003C= 50%\n10. Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:\n\n    * Greater than 2 invasive thoracic procedures\n    * Poor exercise tolerance\n    * Greater than 66 years of age\n    * Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose.\n11. Patients who are receiving any other investigational agents.","72 Years",{"count":190,"type":21},85,[25],"Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with NSCLC who have a tumor that can be safely removed.\n\nDesign:\n\n* Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed\n* Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n* Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.}\n* Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.",[194,29,195,196,197],"Advanced Non-Small Cell Lung Cancer","Advanced NSCLC","Adenosquamous Carcinoma","Adenocarcinoma",[199,200,201,202],"Metastatic","Non-Small Cell Lung Cancer","NSCLC","Lung Cancer","2026-06-05",{"date":205,"type":37},"2026-06-08",{"date":207,"type":37},"2014-10-23",{"date":209,"type":21},"2027-10-23",{"name":211,"class":212},"National Cancer Institute (NCI)","NIH",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":68},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":21},[222],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[197,82,29,225,226,227,228,229,230,231,232,233,234,235,236],"Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Rhabdomyosarcoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":203,"type":37},{"date":240,"type":37},"2026-05-01",{"date":242,"type":21},"2028-05-01",{"name":244,"class":44},"University of California, Irvine",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":263,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100509238","phase-1-a-phase-ibii-study-of-an-anti-her3-antibody-hmbd-001-with-cetuximab---docetaxel-in-advanced-squamous-cell-cancers-100509238","NCT05910827","A Phase Ib\u002FII Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +\u002F- Docetaxel in Advanced Squamous Cell Cancers","A Phase Ib\u002FII Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Ability to understand and be willing to sign an informed consent form\n\n  * Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is \\> 18 years of age)\n  * Eastern Cooperative Oncology Group (ECOG) status of 0 to 1\n  * Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable\n  * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,\n  * Have an estimated life expectancy of at least 3 months\n  * Participants must be willing to provide a fresh tumor biopsy sample\n  * Have adequate organ function\n  * Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal\n  * Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion\n\nExclusion Criteria:\n\n* Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C\n\n  * Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and\u002For KRAS G12C mutation\n  * Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \\>2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and\u002For impact the study results e.g., alopecia\n  * Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment\n  * Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline\n  * Evidence of abnormal cardiac function\n  * History of uncontrolled allergic reactions and\u002For known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into\n  * Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n  * Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment\n  * Known Human Immunodeficiency Virus (HIV) infection\n  * Active hepatitis B or hepatitis C infection\n  * Pregnant or breast feeding\n  * COVID 19 infection within 3 months prior to the first dose of the study drug\n  * COVID 19 vaccination within 14 days prior to the first dose of the study drug\n  * Treatment with strong inhibitors or inducers of CYP3A4",{"count":253,"type":21},398,[24,25],"This is a Phase Ib\u002FII multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers",[257,258,259,260,261,262,29],"Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Esophageal Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Advanced Cutaneous Squamous Cell Carcinoma","Nasopharyngeal Cancinoma (NPC)",[201,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278],"Non-small Cell Lung Cancer","sqNSCLC","Lung","Squamous","HER3","ErbB3","Docetaxel","Cetuximab","cervical squamous cell carcinoma","HNSCC","CSCC","ESCC","advanced squamous cell cancer","NPC","SCC","2026-05-24",{"date":281,"type":37},"2026-05-27",{"date":283,"type":37},"2024-02-05",{"date":285,"type":21},"2027-12",{"name":287,"class":126},"Hummingbird Bioscience",20,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":309,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":68},"100638760","phase-1-a-study-of-idp-001-in-advanced-or-metastatic-solid-tumors-100638760","NCT07602842","A Study of IDP-001 in Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options\n* Satisfy requirements for prior treatments per tumor type as outlined in the protocol\n* Measurable disease per RECIST v1.1\n* Participant willing to provide tumor biopsies\n* Adequate organ function\n* Agree to contraception requirements as outlined in the protocol\n* Life expectancy greater than 12 weeks\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Any clinically significant corneal disorder\n* Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.\n* Active significant neurologic disorders\n* Requires home oxygen\n* Active autoimmune disease\n* History or active skin disease requiring frequent treatment\n* History of major immunologic reaction to prior immunoglobulin G-containing agent\n* Clinically significant ascites or liver disease\n* Uncontrolled diabetes or diabetic neuropathy\n* Active bleeding disorders\n* Participation in a concurrent clinical study in the treatment period\n* Pregnant or lactating or planning to become pregnant\n* Known hypersensitivity to IDP-001 or any of its ingredients\n* Unresolved toxicities from previous anticancer therapy\n* Has had a seizure prior to Screening\n* Prior solid organ transplant or allogeneic stem cell transplant\n* Current endocrinopathy\n* History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis\n* History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids\n* Stroke or transient ischemic attack prior to Screening\n* Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.\n\nNote: Other inclusion and exclusion criteria may apply.",{"count":297,"type":21},132,[24,25],"This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).",[301,302,303,304,305,306,307,308,29],"Advanced Solid Tumor","Metastatic Solid Tumor","Head and Neck Squamous Cell Carcinoma","Cutaneous Squamous Cell Carcinoma","Squamous Cell Carcinoma of the Cervix","Non Squamous Non Small Cell Lung Cancer","Squamous Cell Carcinoma of the Esophagus","Squamous Cell Carcinoma of the Anus",[201,310],"Squamous NSCLC","2026-05-19",{"date":313,"type":37},"2026-05-22",{"date":315,"type":21},"2026-06",{"date":317,"type":21},"2028-12",{"name":319,"class":126},"InduPro, Inc.",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":68},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":328,"type":21},27,[25],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[332,82,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,232,349,350,351,352,353,354,355,356,29,357],"Amyloidosis","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":360,"type":37},"2026-05-18",{"date":362,"type":37},"2025-12-18",{"date":364,"type":21},"2026-12-18",{"name":366,"class":44},"Mayo Clinic",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":395},"100639254","ai-assisted-endoscopy-for-upper-aerodigestive-tract-lesions-100639254","NCT07596355","AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions","Head&Neck Application of Novel Computer-assisted Endoscopy","H&NANCE","Inclusion Criteria:\n\n* Age \\> 18 years\n* Injury originating from the upper aero-digestive tract\n* Recording of the video-endoscopic examination\n* Patient known to undergo a biopsy of the lesion or clinical follow-up for lesion with known biopsy (e.g. laryngeal papillomatosis) or suffering from Reinke's edema (in this pathology, in fact, biopsy is not necessary since the diagnosis is clinical)\n* Or patients undergoing transoral lesion excision\n\nExclusion Criteria:\n\n* Submucosal lesion\n* Patients with previous operations on the upper aero-digestive tract\n* Patients with previous radiotherapy of the head and neck district\n* Poor compliance on endoscopic examination\n* Unavailability of CADe\u002FCADx or CASe data logging note",{"count":376,"type":21},283,"This is a prospective observational clinical study designed to evaluate the performance of artificial intelligence (AI) algorithms applied to upper aerodigestive tract (UADT) video-endoscopy. The study assesses three main tasks: lesion detection (localization), classification (benign vs malignant), and segmentation of tumor margins.\n\nAI algorithms will be applied to endoscopic video data acquired during routine clinical practice without influencing clinical decision-making. The system will process images in real time and store data for subsequent analysis. AI outputs will be compared with physician assessment and reference standard histopathology to evaluate diagnostic performance.",[379,380,381,29,382,383,384,385,386],"Upper Aerodigestive Tract Neoplasms","Upper AerodigestiveTract Cancer","Upper Aero-digestive Tract (UADT) Neoplasm","Leukoplakia","Head and Neck Cancer (H&N)","Vocal Cord Disease","Vocal Fold Polyp","Vocal Fold Nodules","2026-05-12",{"date":311,"type":37},{"date":390,"type":21},"2026-05",{"date":392,"type":21},"2028-02",{"name":394,"class":44},"Istituto Italiano di Tecnologia",3,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":412,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":68},"100573523","phase-1-intratumoral-lidocaine-injection-before-oropharyngeal-cancer-surgery-100573523","NCT06747390","Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery","A Phase I Randomized Controlled Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma","856397","Inclusion Criteria:\n\nPatients 18 years older or more.\n\nHistologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.\n\nClinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).\n\nAny clinical N stage disease (per AJCC 8th Ed).\n\nPatients must be undergoing direct laryngoscopy +\u002F- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.\n\nPatients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.\n\nAbility to understand and the willingness to provide written informed consent.\n\n\\---\n\nExclusion Criteria:\n\nPrior external beam radiation therapy to the head and neck.\n\nPrior chemotherapy for head and neck cancer.\n\nTumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).\n\nPresence of distant metastatic disease.\n\nUncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nKnown history of hypersensitivity to lidocaine or other amide local anesthetics.\n\nPregnant or breastfeeding.",{"count":405,"type":21},30,[24],"Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.",[409,410,411,29],"Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Human Papilloma Virus",[413,414,410,411,29,415],"TransOral Robotic Surgery (TORS)","Oropharyngeal Squamous Cell Carcinoma","Lidocaine","2026-05-10",{"date":387,"type":37},{"date":419,"type":37},"2025-04-23",{"date":421,"type":21},"2028-11-01",{"name":423,"class":44},"Ryan Carey",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":432,"minAge":433,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":444,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":454,"locationsCount":456},"100595184","screening-for-anal-cancer-in-men-who-have-sex-with-men-using-pre-exposure-prophylaxis-100595184","NCT07029152","Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis","Screening for Anal Cancer in MSM Using PrEP","SCOPE","Inclusion Criteria:\n\n* HIV-uninfected MSM (men who have sex with men) aged 35 years or older.\n* participants must have been using PrEP for at least 3 months.\n* Dutch, English or French speaking and writing\n\nExclusion Criteria:\n\n* Any intervention in the (peri-)anal region within the past 3 months\n* Enema usage within 2 h before sampling\n* Currently undergoing peri-anal topical HPV-treatment\n* HRA in the last year (anal swab or HRA prior to the last year is no exclusion)","MALE","35 Years",{"count":435,"type":21},296,[78],"This study aims to learn more about anal cancer risk in men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) to prevent HIV. Specifically, we want to check how common High-Grade Squamous Intraepithelial Lesions (HSIL) are in this group, how well anal swabs can screen for these lesions, and how having HSIL affects their quality of life. We'll also test if DNA methylation testing can give us extra information about the lesions.\n\nThe main questions the study aims to answer are:\n\n* How common are HSIL in MSM using PrEP?\n* How accurate are anal swabs for detecting HSIL in this group?\n* How does having HSIL affect the quality of life of MSM using PrEP?\n* Can DNA methylation testing help improve our understanding of HSIL in these individuals?\n\nParticipants will:\n\n* Answer questions about their health and quality of life.\n* Have an anal smear collected for testing.\n* Undergo High-Resolution Anoscopy (HRA) to check for HSIL and get a biopsy if deemed necessary.",[439,440,441,442,443,29],"Anal Cancer","Squamous Intraepithelial Lesions","HSIL, High Grade Squamous Intraepithelial Lesions","LSIL, Low-Grade Squamous Intraepithelial Lesions","HPV",[445,446,447,448],"HIV prevention","men who have sex with men","pre-exposure prophylaxis (PrEP)","anal cancer","2026-04-30",{"date":240,"type":37},{"date":452,"type":37},"2025-09-23",{"date":123,"type":21},{"name":455,"class":44},"Universitair Ziekenhuis Brussel",8,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":68},"100545670","raman-spectroscopy-and-skin-cancer-100545670","NCT06384924","Raman Spectroscopy and Skin Cancer","Pilot Study of Raman Spectroscopic Imaging for Skin Cancer","Inclusion Criteria:\n\n* Histologically confirmed skin cancer (either basal cell carcinoma or squamous cell carcinoma)\n* Participants must plan to receive brachytherapy treatment for the skin cancer at the study site.\n* Ability to provide consent to the study.\n\nExclusion Criteria:\n\n* Patient belongs to a vulnerable population (Minors (under 18 years old), Adults unable to consent, prisoners).\n* Lesions on the eyelid or in close proximity to the eye\n* Pregnant women, or women of childbearing age who refuse pregnancy testing.\n* Patient has pacemaker.",{"count":288,"type":21},"The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:\n\n-Can Raman Spectroscopy help figure out how far a tumor spreads?\n\nThis study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin.",[115,82,29],{"date":468,"type":37},"2026-05-07",{"date":470,"type":37},"2025-02-13",{"date":472,"type":21},"2027-02-13",{"name":474,"class":44},"Tiezhi Zhang",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":494,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":68},"100609025","phase-2-neoadjuvant-chemotherapy-and-programmed-cell-death-protein-1pd-1-inhibition-for-head-and-neck-cancer-treatment-de-escalation-neoscorch-hn-100609025","NCT07209189","Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","Neoadjuvant Chemotherapy and PD-1 Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","(NeoScorch HN)","Inclusion:\n\n* Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined.\n* HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted surgery.\n* HPV-associated HNSCC with radiographic extranodal extension (cT1-cT3 tonsil or lateralized base of tongue, N0-N1, up to 4 nodes with rENE).\n* Sinonasal\u002Fskull base tumors, including: sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).\n* HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.\n* At least 8 unstained 5-µm slides must be available. If unavailable, a new biopsy is required unless waived by the PI.\n* Appropriate candidates for curative-intent therapy.\n* American Joint Committee on Cancer (AJCC) 7th edition: Stage III-IV, excluding N2c or bulky N2b\u002Fc (N3 equivalent) and bulky T4 (≥30cc).\n* AJCC 8th edition: Stage I with N1, Stage II, or Stage III, excluding N2 disease, bulky nodal disease (N3 equivalent), or bulky T4 (≥30cc).\n* Surgical arm: Candidates must be operable based on upfront imaging\u002Fexam. Patients with Grade 1 rENE may proceed to surgery; Grade 2\u002F3 rENE are excluded.\n* Measurable disease per RECIST 1.1.\n* No prior systemic therapy, radiotherapy, or investigational agents for the current cancer.\n* No complete surgical resection within 8 weeks of enrollment (biopsy or excision with residual disease acceptable).\n* Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky ≥70%.\n* Platelets ≥100,000\u002FµL.\n* Absolute Neutrophil Count (ANC) ≥1,500\u002FµL.\n* Hemoglobin ≥9 g\u002FdL (without recent transfusion\u002FEPO).\n* Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) \\\u003C2.5 × ULN.\n* Albumin ≥2.5 mg\u002FdL.\n* Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total \\>1.5 × ULN (Upper Limit of Normal).\n* Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault or measured GFR).\n* International Normalized Ratio (INR)\u002F Prothrombin Time (PT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Must sign and understand a study-specific informed consent form.\n* Women of childbearing potential (WOCBP): Negative pregnancy test within 72 hours prior to first dose.\n* WOCBP must not be breastfeeding and must agree to use highly effective contraception during therapy and for 120 days after last dose.\n* Men: Must use adequate contraception during treatment and for 120 days after last dose; condom use required in addition to highly effective methods.\n* Azoospermic men and WOCBP not heterosexually active are exempt from contraception but must still undergo pregnancy testing.\n* Counseling on pregnancy prevention is mandatory.\n* Highly effective methods (\\\u003C1% failure rate with consistent use) must be used\n\nExclusion:\n\n* WOCBP with a positive urine pregnancy test within 72 hours before treatment allocation; if positive or inconclusive, a confirmatory serum pregnancy test is required.\n* Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.\n* Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., Cytotoxic T-lymphocyte antigen 4 (CTLA-4), OX40 (Tumor Necrosis Factor Receptor Superfamily Member 4), CD137).\n* Prior systemic anti-cancer therapy or radiotherapy for the current cancer. Surgery is allowed if adequately recovered from complications.\n* Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-Central Nervous System (CNS), non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.\n* Live or live-attenuated vaccines within 30 days of first study dose (including live Corona Virus Disease (COVID-19) vaccines). Inactivated, Messenger ribonucleic acid (mRNA), and peptide vaccines are allowed.\n* Concurrent treatment with other investigational agents.\n* Participation in another investigational drug or device study within 4 weeks before first study dose, unless in follow-up phase only.\n* Diagnosis of immunodeficiency, or receiving chronic systemic steroids at doses \\>10 mg prednisone equivalent daily, or other immunosuppressive therapy within 7 days before study drug.\n* Active autoimmune disease requiring systemic treatment in the past 2 years. Physiologic replacement therapy (thyroxine, insulin, low-dose steroids for adrenal or pituitary insufficiency) is allowed.\n* History of severe hypersensitivity (≥Grade 3) to Toripalimab, its excipients, or other anti-PD-1 agents.\n* Additional active malignancy requiring treatment within 2 years, except basal\u002Fsquamous cell skin cancers, in situ cancers, low-grade tumors unlikely to affect survival within 3 years, or cancers treated with curative therapy.\n* Active CNS metastases or carcinomatous meningitis. Intracranial extension of the primary tumor is allowed. Patients with previously treated brain metastases may enroll if radiologically stable ≥4 weeks, clinically stable, and off steroids ≥14 days before study drug.\n* History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis\u002FInterstitial Lung Disease (ILD).\n* Active infection requiring systemic therapy.\n* Known HIV infection.\n* Known active Hepatitis B (HBsAg positive) or active Hepatitis C (HCV RNA positive). Patients with cleared or eradicated Hepatitis B (HBV) or HCV are eligible.\n* Any condition, therapy, or abnormality that could confound study results, interfere with participation, or be judged by the investigator as not in the participant's best interest.\n* Known psychiatric illness or substance abuse that could interfere with study compliance. Stable chronic managed disorders are acceptable.\n* History of allogeneic tissue or solid organ transplant.\n* Significant cardiovascular disease, including congestive heart failure (NYHA Class III or IV), unstable angina, serious uncontrolled arrhythmia, myocardial infarction within 6 months, or prior myocarditis.",{"count":484,"type":21},75,[25],"The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.",[488,29,489,410,490,491,30,492,493],"Head and Neck Cancer","Oral Cavity Cancer","Laryngeal Cancer","Sinonasal Squamous Cell Carcinoma","Skull Base Tumors","HPV 16 Positive Oropharyngeal Tumors (OPC)",[495,496,497,498,499,150],"head and neck cancer","oral cancer","oropharyngeal cancer","laryngeal cancer","HPV associated","2026-04-21",{"date":502,"type":37},"2026-04-23",{"date":504,"type":37},"2026-02-18",{"date":506,"type":21},"2030-12-01",{"name":508,"class":44},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":532},"100572335","phase-2-impact-of-col7a1-gene-therapy-on-scc-recurrence-in-rdeb-skin-100572335","NCT06731933","Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin","Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin","Inclusion Criteria:\n\n1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations\n2. Presence of biopsy proven squamous cell carcinoma (SCC)\n3. Ability to understand and the willingness to provide written informed consent.\n4. US based participants are willing to use beremagene geperpavec (BVEC)\n5. Subject is 18 years or older\n6. participant willingness to use an effective method of contraception\n\nExclusion Criteria:\n\n1. Inability to travel to site for study visit\n2. Subject is pregnant\n3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.",{"count":517,"type":21},16,[25],"The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence.\n\nPrevention of SCC's in the RDEB subjects will increase their life span.",[29],[522],"gene therapy","2026-04-15",{"date":525,"type":37},"2026-04-20",{"date":527,"type":37},"2025-03-28",{"date":529,"type":21},"2027-02",{"name":531,"class":44},"Stanford University",2,{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":68},"100620708","phase-2-cyclophosphamide-and-etoposide-as-a-metronomic-therapy-in-advanced-head-and-neck-squamous-cell-cancer-100620708","NCT07361133","Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer","Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Adult participants, age = or \\> 18 years\n* Participants with recurrent head and neck squamous cell carcinoma after failure on first line chemotherapy.\n* Participants with advanced progressed, resistant, metastatic head and neck squamous cell carcinoma.\n\nExclusion Criteria:\n\n* Adjuvant and Neoadjuvant head and neck squamous cell carcinoma patients.",{"count":541,"type":21},120,[25],"The goal of this clinical trial is to learn if drugs as cyclophosphamide (C) and etoposide (E) work to treat advanced head and neck cancer in adults. It will also learn about the safety of both drugs. The main questions it aims to answer are:\n\nDo drugs C and E work to treat advanced head and neck cancer, after failure on first line chemotherapy? What medical problems do participants have when taking drugs C and E? Researchers will compare drugs C and E in combination to a placebo (a look-alike substance that contains no drug) to see if these 2 drugs works to treat advanced head and neck cancer.\n\nParticipants will:\n\nTake drug C every 3 weeks and drug E every 4 weeks or a placebo every week for 6 months.\n\nVisit the clinic once every 3 weeks for checkups and tests. Keep a diary of their symptoms.",[29,545],"Advanced Head and Neck Cancer",[547,548,549,199,550,551],"Cyclophosphamide","Etoposide","Head and neck squamous cell carcinoma","Advanced","Recurrent","2026-04-13",{"date":554,"type":37},"2026-04-16",{"date":556,"type":21},"2026-04",{"date":558,"type":21},"2026-09",{"name":560,"class":44},"National Cancer Institute, Egypt",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":22,"phases":571,"briefSummary":572,"conditions":573,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":68},"100610118","phase-2-patient-preference-for-subcutaneous-vs-intravenous-immune-therapy-100610118","NCT07223424","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","PSI-Immune","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document.\n* Able to read and write in English.\n* Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.\n* Prior and concurrent therapy criteria\n\n  o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).\n* Locally advanced or advanced\u002Fmetastatic solid tumor for which nivolumab OR pembrolizumab is on-label.\n\n  * NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric\u002FGEJ).\n  * NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, gastric\u002FGEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC).\n* Cohort-specific criteria.\n\n  * Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer.\n  * Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer.\n  * NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced\u002Fmetastatic melanoma, ccRCC, MSI-H\u002FdMMR mCRC.\n  * NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA).\n  * NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate.\n\nExclusion Criteria:\n\n* Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.\n* Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and\u002For any of its excipients.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":570,"type":21},880,[25],"The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.",[356,574,232,575,344,576,577,29,578,579,580,581],"Non Small Cell Lung Cancer","Colo-rectal Cancer (dMMR\u002FMSI-H CRC)","Ulcerative Colitis","Esophageal Cancer","Gastric\u002FGEJ","Cervical Cancer","Gastro-Esophageal Adenocarcinoma","Esophageal Adenocarcinoma",{"date":554,"type":37},{"date":584,"type":37},"2025-11-04",{"date":586,"type":21},"2030-11-30",{"name":588,"class":44},"Diwakar Davar",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":22,"phases":597,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":68},"100219048","phase-2-radiotherapy-with-cisplatin-vs-docetaxel-cetuximab-in-hnscc-ercc1-biomarker-enrichment-and-interaction-design-100219048","NCT02128906","Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design","A Randomized, Phase II Study of Definitive Radiotherapy With Concurrent Cisplatin vs. Docetaxel-cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma: an ERCC1 Biomarker Enrichment and Interaction Design","Inclusion Criteria:\n\n* Pathologically confirmed squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma of the oropharynx, larynx, or hypopharynx with no evidence of distant metastasis. Biopsy sampling of primary tumor with pathology report documenting diagnostic tissue type is required.\n* Patients must have stage III, IVa or IVb disease as determined by imaging studies and complete head and neck exam. Staging evaluation should be in accordance with the American Joint Committee on Cancer Staging Manual, 7th edition.\n* Patients with oropharyngeal squamous cell carcinoma may have p16(+) or p16(-) disease; in these patients, p16 status must be known prior to randomization. Assessment of p16 status may occur locally or centrally. Note: The definition of p16(+) disease is diffuse nuclear and cytoplasmic staining in ≥ 70% of tumor cells.\n* Patients must be untreated with curative-intent surgery for current diagnosis of Stage III, IVa, or IVb disease. Diagnostic biopsy of primary tumor and\u002For nodal sites is permitted.\n* Diagnostic simple tonsillectomy is permitted, provided patient has RECIST-measurable residual tumor and\u002For nodal disease.\n* Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy\u002Fradiotherapy), and has not recurred.\n* Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible.\n* No prior systemic treatment (chemotherapy or biologic\u002Fmolecular targeted therapy) or radiation treatment for head and neck cancer.\n* Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed.\n* Patients must be untreated with radiation above the clavicles.\n* Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least 2 years except for carcinoma-in-situ of cervix, non-melanomatous skin cancer, or T1-2, N0, M0 resected differentiated thyroid carcinoma.\n* Diagnostic primary tumor tissue must be available for ERCC1 staining\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 (See Appendix 8)\n* Age ≥ 18\n* Patients must have measurable disease according to RECIST 1.1\n* Patients must have the following laboratory values measured within 14 days of registration:\n* Absolute neutrophil count (ANC) \\> 1500\u002Fmm3\n* Hemoglobin (Hb) \\> 8.0 g\u002FdL\n* Platelet count (PLT) \\> 100,000\u002Fmm3\n* Creatinine clearance ≥ 45 ml\u002Fmin determined by 24-hour collection or estimated by the Cockraft-Gault formula:\n\nCalculated Creatinine Clearance = \\[(140-age) X (actual body weight in kg) X (0.85 if female)\\]\u002F(72 X serum creatinine)\n\n* Serum bilirubin \\\u003C 2 mg\u002FdL\n* AST (aspartate aminotransferase) and ALT (alanine aminotransferase) \\\u003C 3 times upper limit of normal (ULN)\n* The following assessments are required within 14 days prior to registration: Na, K, Cl, glucose, Ca, Mg, and albumin. The following metabolic values will exclude patients from study enrollment:\n* Serum calcium (ionized or adjusted for albumin) \\\u003C 7 mg\u002Fdl (1.75 mmol\u002FL) or \\> 12.5 mg\u002Fdl (\\> 3.1 mmol\u002FL) despite intervention to normalize levels\n* Magnesium \\\u003C 0.9 mg\u002Fdl (\\\u003C 0.4 mmol\u002FL) or \\> 3 mg\u002Fdl (\\> 1.23 mmol\u002FL) despite intervention to normalize levels\n* Potassium \\\u003C 3.5 mmol\u002FL or \\> 6 mmol\u002FL despite intervention to normalize levels\n* Sodium \\\u003C 130 mmol\u002FL or \\> 155 mmol\u002FL despite intervention to normalize levels Note: Patients with an initial magnesium \\\u003C 0.5 mmol\u002FL (1.2 mg\u002Fdl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and\u002For oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion.\n* No prior severe infusion reaction to a monoclonal antibody\n* Written informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.\n* Informed consent must be obtained from all patients prior to beginning therapy, including consent for mandatory tissue submission for ERCC1 staining (and p16 staining if not locally conducted). Patients should have the ability to understand and the willingness to sign a written informed consent document.\n* No unstable angina or myocardial infarction within the prior 6 months; no symptomatic congestive heart failure; no serious cardiac arrhythmia requiring medication; no cerebrovascular ischemia or stroke within the past 6 months.\n* No uncontrolled intercurrent illness including active infection, uncontrolled diabetes, uncontrolled hypertension, or uncontrolled psychiatric illness which in the investigator's opinion would limit compliance with study requirements or compromise patient safety.\n* Women must not be pregnant or breast feeding because chemotherapy and\u002For cetuximab may be harmful to the fetus or the nursing infant. Pregnant women are excluded from this study because chemotherapy and\u002For cetuximab have the potential for teratogenic or abortifacient effects.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately. All females of childbearing potential must have a blood test or urine study within 14 days of registration to rule out pregnancy.\n* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible drug interactions with study drugs. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. Note: HIV testing is not required for entry into this protocol.\n* Patients may not be receiving any other anti-neoplastic investigational agents.",{"count":541,"type":21},[25],"The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied.\n\nThis study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status and the presence of ERCC-1 \\[4F9\\] in the tumor prior to randomization. The study will evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 \\[4F9\\] is expressed in a tumor.",[29],[601,602,603,604,605,606,607,608,609,610,611],"ERCC1","oropharynx","larynx","hypopharynx","p16","radiotherapy","docetaxel","cetuximab","cisplatin","EGFR","head and neck",{"date":554,"type":37},{"date":614,"type":37},"2013-12-23",{"date":616,"type":21},"2031-12-16",{"name":618,"class":44},"Christopher Wilke",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":626,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":641,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":68},"100573965","electrochemotherapy-ect-in-patients-with-primary-visceral-tumors-andor-secondary-visceral-localizations-of-any-histotype-100573965","NCT06753136","Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype","Treatment of Visceral Localizations With Electrochemotherapy in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype: Monocenter, Single Arm, Clinical Investigation","Inclusion Criteria:\n\n* Male\u002FFemale ≥ 18 years\n* Ability to understand the proposed treatment and express an informed acceptance by signing the informed consent\n* Diagnosis of primary and\u002For secondary visceral localizations of any histotype\n* Patients who are not eligible for standard curative procedures\n\nExclusion Criteria:\n\n* Absolute contraindications to invasive procedures\n* Concomitant presence of brain, lung, bone metastases\n* Uncorrectable coagulation changes\n* Bleomycin allergy\n* Absolute contraindications to taking Bleomycin\n* Poor respiratory function or pulmonary fibrosis\n* Acute lung infections\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study","99 Years",{"count":628,"type":21},24,[78],"This is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. Electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes.\n\nAlthough still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. The investigators therefore propose a clinical investigation with a Medical Device according to EU Regulation 745\u002F2017, using electrochemotherapy (Cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.",[632,633,634,635,232,636,637,638,349,29,639,640],"Primary Visceral Tumors of Any Histotype","Visceral Lesions","Liver Cancer","Liver Metastasis Colon Cancer","Primary Pancreatic Tumor","Retroperitoneal Sarcoma","Abdominal and\u002For Peritoneal Localizations","Secondary Visceral Localizations of Any Histotype","Non-melanoma Skin Cancer",[642,643,644,645,646,647,648],"electrochemotherapy","visceral lesions","Laparoscopic procedure","Laparotomic procedure","Percutaneous procedure","bleomycin","medical device","2026-04-09",{"date":552,"type":37},{"date":652,"type":37},"2025-07-23",{"date":654,"type":21},"2030-02-28",{"name":656,"class":44},"Istituto Oncologico Veneto IRCCS",{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":22,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":687},"100550264","phase-1-a-study-of-vet3-tgi-in-patients-with-solid-tumors-100550264","NCT06444815","A Study of VET3-TGI in Patients With Solid Tumors","A Phase 1\u002F1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors","STEALTH-001","Key Inclusion Criteria:\n\n* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.\n* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab\u002FPDL1 antibodies), and chemotherapy\n* Measurable disease as per RECIST 1.1 criteria\n* At least one tumor amenable to safe ITu injections and\u002For biopsies\n* ECOG performance status 0 or 1\n* Demonstrate adequate organ function\n* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions\n\nAdditional Inclusion criteria exist\n\nKey Exclusion Criteria:\n\n* Prior systemic therapy washout (dependent upon the therapy)\n* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.\n* CNS metastases and\u002For carcinomatous meningitis that have not been completely resected or completely irradiated.\n* Prior history of myocarditis\n* Known HIV\u002FAIDS, active HBV or HCV infection.\n* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).\n\nAdditional Exclusion criteria exist",{"count":666,"type":21},60,[24],"VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).",[670,671,303,579,672,356,673,674,675,264,676,677,29],"Solid Tumor, Adult","Microsatellite Stable Colorectal Cancer","Kidney Cancer","Melanoma Stage IV","Merkel Cell Carcinoma of Skin","Mesothelioma","Cutaneous Squamous Cell Carcinoma (CSCC)","Urothelial Carcinoma Bladder","2026-04-01",{"date":680,"type":37},"2026-04-07",{"date":682,"type":37},"2024-09-16",{"date":684,"type":21},"2027-12-31",{"name":686,"class":126},"KaliVir Immunotherapeutics",7,{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":4,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":695,"targetDuration":4,"studyType":22,"phases":696,"briefSummary":697,"conditions":698,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":701,"completionDateStruct":703,"leadSponsor":705,"locationsCount":68},"100526632","phase-2-phase-2-trial-of-adaptive-radiotherapy-boost-for-hnscc-100526632","NCT06137274","Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCC","Phase 2 Trial of Adaptive Radiotherapy Boost for Head and Neck Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* ECOG performance status of 0, 1\n* Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck.\n* Patients with measurable disease, either at primary site or neck per RECIST 1.1.\n* For patients planned to receive chemotherapy, adequate hematologic, hepatic and renal function as outlined in protocol.\n* International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history.\n* Negative serum pregnancy test within before starting study treatment in woman with childbearing potential.\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer.\n* Patients who had undergone definitive surgery for the index cancer.\n* Patients with distant metastatic disease\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":20,"type":21},[25],"The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.",[29,488],"2026-03-31",{"date":678,"type":37},{"date":702,"type":37},"2023-12-14",{"date":704,"type":21},"2027-05",{"name":706,"class":44},"H. Lee Moffitt Cancer Center and Research Institute",{"id":708,"slug":709,"hasResults":12,"nctId":710,"briefTitle":711,"officialTitle":711,"acronym":4,"eligibilityCriteria":712,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":713,"targetDuration":4,"studyType":22,"phases":714,"briefSummary":715,"conditions":716,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":719,"lastUpdatePostDateStruct":720,"startDateStruct":722,"completionDateStruct":724,"leadSponsor":726,"locationsCount":68},"100441382","phase-2-immunotherapy-with-chemotherapy-and-chemoradiation-for-advanced-squamous-cancer-of-nasal-cavity--paranasal-sinuses-i-napa-100441382","NCT05027633","Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity \u002F Paranasal Sinuses (I-NAPA)","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and\u002For cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.\n* Male participants:\n\nA male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n-Female participants:\n\nA female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.\n\n   * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n   * Have measurable disease based on RECIST 1.1.\n   * Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n   * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Patients must not have received prior systemic anti-cancer therapy including investigational agents or radiation therapy for PNS SCC but could have received treatment for prior cancers if greater than 2 years (refer to Item 8 for further details).",{"count":20,"type":21},[25],"This is a single arm phase II study that will evaluate the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as single treatment modality in patients with stage II-IVb (T2-4, any N, M0) squamous cell carcinoma of the nasal cavity\u002Fparanasal sinuses (PNS SCC).",[29,717,718],"the Nasal Cavity","Paranasal Sinuses","2026-03-18",{"date":721,"type":37},"2026-03-20",{"date":723,"type":37},"2021-11-02",{"date":725,"type":21},"2028-03-30",{"name":180,"class":44},{"id":728,"slug":729,"hasResults":12,"nctId":730,"briefTitle":731,"officialTitle":732,"acronym":733,"eligibilityCriteria":734,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":735,"targetDuration":737,"studyType":138,"phases":4,"briefSummary":738,"conditions":739,"keywords":744,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":747,"lastUpdatePostDateStruct":748,"startDateStruct":750,"completionDateStruct":752,"leadSponsor":754,"locationsCount":756},"100592655","prospective-data-collection-initiative-on-thoracic-malignancies-100592655","NCT06996249","Prospective Data Collection Initiative on Thoracic Malignancies","Prospective Data Collection Initiative on Thoracic Malignancies - a Prospective Observational Cohort Study","DuTOC","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histo\u002Fcytopathological proof of a thoracic malignancy, or a strong suspicion (after imaging and multidisciplinary board);\n* Informed consent for longitudinal observational data collection;\n\nExclusion Criteria:\n\n* Mentally challenged patients that are unable to provide conscientious informed consent as determined by the investigator.\n* Inability to provide a written or electronic informed consent.",{"count":736,"type":21},12000,"50 Years","Survival after cancer diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of molecular factors, biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage. It is however still unclear which, how, and to what extent these factors will influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) thoracic malignancies such as lung cancer.\n\nAlthough the results from prospective clinical trials will remain the backbone of evidence-based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of patients with cancer do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications:\n\n1. It is highly desirable to validate the results from clinical trials in the general patient population. This is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters.\n2. There is an ever increasing number of therapeutic interventions available for which its efficacy depends on known and unknown tumor-specific, clinical, demographic and other patient characteristics. Large numbers of patients are required to test the relevance of these variables.\n3. As a result of rapid technical and drug developments, new minimally invasive treatment options such as stereotactic irradiation or ablation techniques or sublobar resections and new targeted and immunotherapeutic treatments have entered the clinic. These interventions have potentially less side effects compared to the conventional treatments. Still, these new interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) in a real world setting.\n4. Many hypotheses related to further optimization of personalized medicine can currently not be tested as they require a large prospective cohort of patients, and a less time-consuming and costly research infrastructure.\n\nA prospective observational cohort study has the potential to fill the gap between prospective randomized trials (efficacy) and patients treated in general practice (effectiveness) and it will enable accrual of clinical trials (innovation).",[202,740,741,197,29,742,743,675],"Thoracic Cancer","Lung Cancer, Nonsmall Cell","Large Cell Lung Cancer","Thymus Cancer",[745,746],"Dutch lung cancer cohort","lung cancer cohort","2026-03-02",{"date":749,"type":37},"2026-03-03",{"date":751,"type":37},"2025-08-15",{"date":753,"type":21},"2030-01-01",{"name":755,"class":44},"Dutch Society of Physicians for Pulmonology and Tuberculosis",10]