[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-squamous-cell-carcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,80,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100639751","phase-2-effects-of-infusion-timing-on-treatment-response-in-solid-tumors-100639751",false,"NCT07630168","Effects of Infusion Timing on Treatment Response in Solid Tumors","Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors","TIMED","Inclusion Criteria:\n\nCohort 1A and 1B:\n\n* Participants with metastatic non-small cell lung cancer (NSCLC).\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nCohort 2A and 2B:\n\n* Participants with resectable head and neck squamous cell carcinoma (HNSCC)\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement\n* of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nExclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)\n\n* Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.\n* Prior ICI (PD-1\u002FPD-L1\u002FCTLA4) treatment received less than 6 months from the time of screening.\n* Subject is participating in another treatment clinical trial.","ALL","18 Years",{"count":20,"type":21},238,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.",[27,28,29,30,31,32,33],"Lung Cancer","Non-small Cell Lung Cancer","Metastatic Lung Cancer","Head and Neck Cancer","Metastatic Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Resectable Head and Neck Squamous-cell Carcinoma",[35,36],"programmed cell death protein 1","programmed death-ligand 1","NOT_YET_RECRUITING","2026-06-01",{"date":40,"type":41},"2026-06-05","ACTUAL",{"date":38,"type":21},{"date":44,"type":21},"2033-01-01",{"name":46,"class":47},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100625194","phase-2-5-fluorouracil-response-and-optimization-study-the-frost-trial-100625194","NCT07419464","5-Fluorouracil Response and Optimization STudy (The FROST Trial)","The 5-Fluorouracil Response and Optimization STudy (The FROST Trial): A Randomized Phase II Trial of Two Dosage Regimens (2D-Q2W vs 4D-Q3W) of 5-Fluorouracil (5-FU) in Patients With Platinum and PD-1 Inhibitor Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed:\n\n  * RM-HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx, OR\n  * p16+ (HPV-related) level 2-3 neck node and unknown primary site, OR\n  * Second primary HNSCC in a previously radiated field not amenable to curative-intent surgery and\u002For re-radiation.\n* Measurable disease per RECIST 1.1.\n* Previously treated with platinum-based chemotherapy, RM disease within 6 months of definitive cisplatin + radiation therapy (DCisRT) or post-operative adjuvant cisplatin + radiation therapy (POACisRT) OR progressive disease on or after or intolerance to platinum agent given for RM disease.\n* Previously treated with PD-1 inhibitor, RM disease within 6 months of PD-1 inhibitor given as part of curative-intent therapy OR progressive disease on or after PD-1 inhibitor given for RM disease OR intolerance to prior PD-1 inhibitor in the curative or metastatic setting.\n* At least 18 years of age\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease ≤ 3 x IULN)\n  * AST(SGOT)\u002FALT(SGPT)\u002FAlkaline Phosphatase (ALP) ≤ 3.0 x IULN. For subjects with documented bone metastasis, ALP ≤ 5.0 x IULN.\n  * Serum creatinine \\\u003C3 mg\u002FdL or creatinine clearance \\> 30 mL\u002Fmin by Cockcroft- Gault.\n* The effects of 5-FU on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after last dose of 5-FU\n* Recovery to baseline or ≤ grade 1 from AEs due to prior therapy, unless AEs are clinically nonsignificant and\u002For stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ grade 2 hypomagnesemia, or ≤ grade 2 neuropathy are permitted.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior 5-FU given to treat RM-HNSCC.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving any other investigational agents.\n* RM or incurable second primary SCC of cutaneous, nasopharynx, paranasal\u002Fnasal\u002Fsinus origin.\n* DPYD deficiency (poor or intermediate metabolizer) as determined by next generation sequencing through blood or saliva (results of historical testing are accepted).\n* Severe hepatic impairment (Child-Pugh C) or history of hepatitis B or C.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-FU or other agents used in the study.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 14 days of study registration.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.",{"count":57,"type":21},46,[24],"This randomized phase II trial will characterize the efficacy, adverse event (AE) profile, and safety of two regimens of 5-FU given as 2L+ treatment to patients with RM-HNSCC. Eligible patients for this trial will have previously received platinum and PD-1 inhibitor therapy. The experimental regimen (Arm 1) will comprise the two days every two weeks (2D-Q2W) regimen of 5-FU. The standard regimen (Arm 2) will consist of the four days every three weeks (4D-Q3W) regimen of 5-FU. The primary hypotheses is that each regimen of 5-FU will result in an ORR of 10% of greater assessed by RECIST v1.1 criteria. The study will also describe treatment-related AEs assessed by CTCAE v5.0, dose interruptions, discontinuations, and modifications in each regimen.",[61,31,62],"Squamous Cell Carcinoma of Head and Neck","Recurrent Squamous Cell Carcinoma of the Head and Neck",[64,65,66,67,68,69,70],"5-FU","HNSCC","RM-HNSCC","Oral cavity","Oropharynx","Larynx","Hypopharynx","RECRUITING","2026-04-21",{"date":74,"type":41},"2026-04-27",{"date":72,"type":41},{"date":77,"type":21},"2031-07-31",{"name":79,"class":47},"Washington University School of Medicine",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":48},"100586185","phase-1-dose-finding-study-of-zanzalintinib-with-pembrolizumab-and-cetuximab-in-head-and-neck-scc-100586185","NCT06912087","Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC","A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and\u002For Metastatic Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n* Histologically or cytologically confirmed recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC), which is considered incurable by local therapies.\n* Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible.\n* Age: Participants must be at least 18 years old.\n* ECOG Performance Status: Must be 0-1.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.\n* For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing.\n* Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R\u002FM disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy.\n* Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from any adverse events (AEs), including immune-related AEs from prior treatments.\n* Adequate organ and marrow function, including:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n* Platelets ≥ 100,000\u002Fmm3.\n* Hemoglobin ≥ 9 g\u002FdL.\n* Normal liver and kidney function.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Contraception: Sexually active fertile subjects must agree to use a highly effective method of contraception during the study and for 2 months after the last dose of cetuximab and 4 months after the last dose of pembrolizumab.\n\nExclusion Criteria:\n\n* Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors.\n* More than two prior lines of systemic therapy in the recurrent\u002Fmetastatic setting.\n* Relapsed disease within 3 months of definitive therapy.\n* Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment).\n* Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks.\n* Concomitant anticoagulation with oral anticoagulants or platelet inhibitors, unless on stable doses of acceptable anticoagulants.\n* Active infection requiring systemic treatment or significant cardiovascular, gastrointestinal, or other serious health issues that may affect study participation.\n* Known or suspected autoimmune disease, except for specific conditions like type I diabetes or controlled skin disorders.\n* Pregnancy or breastfeeding: Women must not be pregnant or breastfeeding at screening.\n* Other malignancies within the past 2 years (except for certain low-grade cancers like localized skin cancers).",{"count":88,"type":21},36,[90],"PHASE1","This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).",[93,94,95,96,97,31],"Head and Neck Neoplasms","Carcinoma, Squamous Cell","Neoplasm Recurrence, Local","Neoplasm Metastasis","Recurrent Squamous Cell Carcinoma","2025-12-01",{"date":100,"type":41},"2025-12-02",{"date":102,"type":41},"2025-09-29",{"date":104,"type":21},"2027-06-05",{"name":106,"class":47},"University of Chicago",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100431152","phase-2-combination-of-spartalizumab-mdcf-and-radiotherapy-in-patients-with-metastatic-squamous-cell-anal-carcinoma-100431152","NCT04894370","Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma","Spartalizumab, mDCF (Docetaxel, Cisplatin and 5-fluorouracil) and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma. A Phase IIA Study","SPARTANA","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years,\n2. Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,\n3. Histologically proven metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA)\n4. Presence of a evaluable lesion on CT-scan\u002FMRI assessed by RECIST v1.1 criteria,\n5. Patient eligible to the mDCF regimen\n6. CT scan performed within 30 days prior inclusion,\n7. PET scan performed within 30 days prior inclusion\n8. Life expectancy ≥12 months,\n9. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:\n\n   * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (≥ 1.5 GI\u002FL) without granulocyte colony-stimulating factor support.\n   * White blood cell count ≥ 2500\u002Fmm3 (≥ 2.5 GI\u002FL).\n   * Platelets ≥ 100,000\u002Fmm3 (≥ 100 GI\u002FL) without transfusion.\n   * Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL).\n   * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN with documented liver metastases.\n   * Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).\n   * Serum albumin ≥ 2.8 g\u002Fdl.\n   * Calculated creatinine clearance ≥ 60 mL\u002Fmin (using the MDRD formula):\n   * Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1 g\u002Fg\n10. Signed and dated informed consent, to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study\n11. Patient affiliated to or beneficiary of French social security system\n12. Ability to comply with the study protocol, in the Investigator's judgment\n\nExclusion Criteria:\n\n1. HIV positive patient , CD4 count \\\u003C 400 cells\u002Fmm3 (HIV test mandatory before inclusion)\n2. Diagnosis of additional malignancy within 2 years prior to the inclusion with the exception for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy,\n3. Any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,\n4. Current participation in a study of an investigational agent or in the period of exclusion,\n5. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment,\n6. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible,\n7. Pregnancy, breast-feeding or absence\u002Frefusal of adequate contraception for fertile patients during the period of treatment and for 6 months from the last treatment administration,\n8. Patient under guardianship, curatorship or under the protection of justice.\n9. Inability to perform radiotherapy\n10. Untreated or symptomatic central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 2 weeks\n11. Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior start of study treatment. If erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.\n12. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment\n13. Elevated Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) elevation \\> 2x ULN\n14. Systemic chronic steroid therapy (\\> 10mg\u002Fday prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment.\n\n    Note: Topical, inhaled, nasal and ophthalmic steroids are allowed. For patients with adrenal insufficiency, replacement dose of prednisone \\> 10 mg\u002F day or equivalent are permitted\n15. Active, known or suspected autoimmune disease or a documented history of autoimmune disease Note: Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted.\n16. Allogenic bone marrow or solid organ transplant\n17. History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction\n18. Pre-existing neuropathy, hearing problem, or cardiorespiratory pathology, which prevent the administration of cisplatin.\n19. clinically significant active heart disease or myocardial infarction within 6 months\n20. recent or concomitant treatment with brivudine\n21. persistent toxicities related to prior treatment of grade greater than 1\n22. History or current interstitial lung disease or non-infectious pneumonitis\n23. History of major surgery within 28 days before treatment\n24. Active infection\n25. Active Hepatitis B infection (HBsAg positive)\n26. Active hepatitis C (HCV RNA positive)\n27. Pregnant or nursing (lactating) women confirmed by a positive hCG laboratory test within 72 hours prior to initiating study treatment.\n\n    Note: Low levels of hCG may also be considered a tumor marker, therefore if low hCG levels are detected, another blood sample at least 4 days later must be taken to assess the kinetics of the increase and transvaginal ultrasound must be performed to rule out pregnancy.\n28. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7.5 months after stopping treatment with Spartalizumab.\n29. Complete or partial deficit in dihydropyrimidine dehydrogenase (DPD) activity\n30. Active inflammatory bowel disease Note: In case of a history of inflammatory bowel disease, it is advisable to take the advice of the referring gastroenterologist of the patient to ensure the absence of the evolution of inflammatory bowel disease (inflammatory thrust in progress) before the initiation of docetaxel treatment",{"count":116,"type":21},34,[24],"This study evaluates the feasibility of the combination of radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and spartalizumab (anti-PD-1 therapy) in patients with metastatic squamous cell anal carcinoma",[120,31],"Squamous Cell Anal Carcinoma",[122,123,124,125],"immunotherapy","chemotherapy","radiotherapy","anti-PD1","2023-12-21",{"date":128,"type":41},"2023-12-22",{"date":130,"type":41},"2022-06-09",{"date":132,"type":21},"2026-11-01",{"name":134,"class":47},"Centre Hospitalier Universitaire de Besancon",5]