[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657735":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":65,"studyPopulation":62,"armGroups":66,"interventions":78,"overallOfficials":92,"centralContacts":96,"locations":102,"responsibleParty":262,"collaborators":264,"id":267,"slug":268,"hasResults":269,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":269,"sex":275,"minAge":276,"maxAge":62,"enrollmentInfo":277,"targetDuration":62,"studyType":280,"phases":281,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":295,"whyStopped":62,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"6-Month Progression-Free Survival Rate (R\u002FM cohort only)","Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. The outcome measure is the proportion of participants who are alive and progression-free 6 months after enrollment.","6 months after enrollment",[14,18,22,26,30,34],{"measure":15,"description":16,"timeFrame":17},"Change in systematic inflammation (Neutrophil-to-Lymphocyte Ratio, NLR)","Percentage of participants achieving normalisation of the neutrophil-to-lymphocyte ratio (NLR) after completion of JAK-inhibition treatment. NLR is calculated as the absolute neutrophil count divided by the absolute lymphocyte count. Participants are considered to have achieved NLR normalisation if the post-treatment NLR meets the protocol-defined threshold for a normal NLR value.","R\u002FM cohort: at screening within 21 days before start of ruxolitinib or at week 6 (baseline) and at week 12. Neoadjuvant cohort: at screening within 21 days before start of ruxolitinib or at week 3 (baseline), at week 5 and at week 12.",{"measure":19,"description":20,"timeFrame":21},"Adherence to Planned JAK-Inhibition Treatment (R\u002FM cohort only)","Proportion of participants who complete the planned JAK-inhibition treatment duration. Participants are considered adherent if they receive JAK-inhibition according to the protocol-defined treatment schedule and duration without premature discontinuation.","From initiation of ruxolitinib treatment to Week 12 (up to 6 weeks of treatment).",{"measure":23,"description":24,"timeFrame":25},"Tumour response (R\u002FM cohort only)","Best tumour response at week 12 by investigator assessment (objective response rate). Rationale: early signal of anti-tumour activity","Week 12",{"measure":27,"description":28,"timeFrame":29},"Overall survival (R\u002FM cohort only)","Overall survival is defined as the time from enrollment to death from any cause. Survival status will be assessed during follow-up and recorded every 6 months.","From enrollment until death from any cause or until the end of study follow-up (up to approximately 5 years).",{"measure":31,"description":32,"timeFrame":33},"Quality of Life Assessed by EORTC QLQ-C30 (R\u002FM cohort only).","Change in quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a 0-100 scale according to the EORTC scoring manual. Higher functional-scale scores indicate better functioning, whereas higher symptom-scale scores indicate greater symptom burden.","At screening, week 12 and week 18",{"measure":35,"description":36,"timeFrame":37},"Quality of Life Assessed by EORTC QLQ-H&N43 (R\u002FM cohort only)","Change in head and neck cancer-specific quality of life measured using the uropean Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-H\\&N43) questionnaire. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. Higher symptom scores indicate greater symptom burden.","At screening, week 12, week 18",[39,43,47,50,53],{"measure":40,"description":41,"timeFrame":42},"Plasma Inflammatory Biomarkers","Change in circulating inflammatory biomarkers, including plasma cytokines and other soluble factors, from before initiation of JAK-inhibition to after completion of JAK-inhibition treatment, measured using multi-analyte plasma assays.","Baseline and after completion of JAK-inhibition treatment.",{"measure":44,"description":45,"timeFrame":46},"≥20% Increase in T Cell Richness or Diversity","Percentage of participants achieving a relative increase of at least 20% in peripheral blood T cell richness or diversity between initiation and completion of JAK-inhibition treatment, measured by T cell receptor next-generation sequencing (TCR-NGS).","Before initiation of ruxolitinib treatment and after completion of ruxolitinib treatment (Week 6 and Week 12 in the R\u002FM cohort; Week 3 and Week 5-6 in the neoadjuvant cohort).",{"measure":48,"description":49,"timeFrame":46},"≥20% Decrease in T Cell Clonality","Percentage of participants achieving a relative decrease of at least 20% in peripheral blood T cell clonality between initiation and completion of JAK-inhibition treatment, measured by T cell receptor next-generation sequencing (TCR-NGS).",{"measure":51,"description":52,"timeFrame":46},"T Cell Richness, Diversity, and Clonality","Levels of peripheral blood T cell richness, diversity, and clonality measured by T cell receptor next-generation sequencing (TCR-NGS) before initiation and after completion of JAK-inhibition treatment.",{"measure":54,"description":55,"timeFrame":56},"Safety and Tolerability","Number of participants experiencing adverse events and serious adverse events. Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0, including Grade 3 to 5 events.","From initiation of ruxolitinib treatment through completion of safety follow-up (Week 6 to Week 18 in the R\u002FM cohort; Week 3 to Week 12 in the neoadjuvant cohort)",{"allocation":58,"interventionModel":59,"interventionModelDescription":60,"primaryPurpose":61,"observationalModel":62,"timePerspective":62,"maskingInfo":63},"NON_RANDOMIZED","SINGLE_GROUP","Multicenter, non-randomized, two-cohort, phase 2 trial","TREATMENT",null,{"masking":64,"maskingDescription":62,"whoMasked":62},"NONE","Head and neck squamous cell carcinoma (HNSCC) remains associated with poor outcomes in a substantial proportion of patients despite the introduction of immune checkpoint inhibitors. An elevated neutrophil-to-lymphocyte ratio (NLR), a marker of systemic inflammation, has been associated with reduced survival in patients receiving immune checkpoint inhibitor therapy and may identify a subgroup of patients at increased risk of poor treatment outcomes.\n\nJanus kinase (JAK) inhibition represents a potential strategy to modulate cancer-associated systemic inflammation and the tumor immune microenvironment. Ruxolitinib, a JAK1\u002F2 inhibitor, has demonstrated anti-inflammatory effects and may enhance the activity of immune checkpoint inhibition by reducing inflammatory signaling pathways that could contribute to treatment resistance.\n\nThis study uses a biomarker-driven treatment approach in patients with PD-L1-positive recurrent, metastatic, or locally advanced HNSCC who have evidence of increased systemic inflammation prior to treatment initiation. The study is designed to investigate the effects of combining pembrolizumab with intermittent ruxolitinib and to evaluate whether this approach can favorably influence systemic inflammation and immune responses while maintaining acceptable tolerability.\n\nPatients with advanced HNSCC are frequently frail and may be unable to tolerate the toxicities associated with conventional chemotherapy-based treatment approaches. Consequently, there is a need for treatment strategies that are both effective and well tolerated in patients with reduced performance status. The present study therefore focuses on a population with an inflammatory high-risk phenotype and seeks to generate clinical and translational evidence to support future treatment development.\n\nIn addition to evaluating the clinical activity and tolerability of the combination regimen, the study will characterize treatment-associated changes in systemic inflammation and adaptive immune responses. The findings are intended to provide a better understanding of the relationship between inflammatory biomarkers, immune modulation, and clinical outcomes in HNSCC, and to inform the design of future randomized studies evaluating JAK inhibition in combination with immune checkpoint blockade.",[67,74],{"label":68,"type":69,"description":70,"interventionNames":71},"R\u002FM cohort","EXPERIMENTAL","Patients with recurrent or metastatic (R\u002FM) HNSCC receiving the immune checkpoint inhibitor pembrolizumab who are found to have an increased pretreatment neutrophil-to-lymphocyte ratio (NLR) receive additional intermittent treatment with ruxolitinib tablets twice daily during weeks 6-12 of pembrolizumab treatment. Pembrolizumab is administered according to local standard of care",[72,73],"Drug: Ruxolitinib","Drug: Pembrolizumab",{"label":75,"type":69,"description":76,"interventionNames":77},"Neoadjuvant Cohort","Patients with curative locally advanced HNSCC receiving the immune checkpoint inhibitor pembrolizumab who are found to have an increased pretreatment neutrophil-to-lymphocyte ratio (NLR) receive additional intermittent treatment with ruxolitinib tablets twice daily from week 3 to week 5 of neoadjuvant pembrolizumab treatment. Pembolizumab will be administered as per standard of care at the local site.",[72,73],[79,86],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"DRUG","Ruxolitinib","Ruxolitinib administered orally on an intermittent schedule in combination with pembrolizumab.",[75,68],[85],"Janus kinase inhibitors",{"type":80,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"Pembrolizumab","Pembrolizumab administered as standard-of-care immune checkpoint inhibitor therapy.",[75,68],[91],"Immune checkpoint inhibitor",[93],{"name":94,"affiliation":5,"role":95},"Anna Brandt, PD Dr.","PRINCIPAL_INVESTIGATOR",[97],{"name":94,"role":98,"phone":99,"phoneExt":100,"email":101},"CONTACT","(0)61 328 49 52","0041","anna.brandt@usb.ch",[103,122,138,154,170,181,197,213,229,246],{"facility":104,"status":62,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Universitätslklinikum Würzburg","Würzburg","Bavaria","97080","Germany","DE",{"type":111,"coordinates":112},"Point",[113,114],9.95121,49.79391,{"lat":114,"lon":113},[117,121],{"name":118,"role":98,"phone":119,"phoneExt":62,"email":120},"Urs Müller-Richter, Prof. Dr.","0049 (0)931 201-72720","mueller_u2@ukw.de",{"name":118,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":123,"status":62,"city":124,"state":125,"zip":126,"country":108,"countryCode":109,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Universitätsmedizin Greifswald","Greifswald","Mecklenburg-Vorpommern","17475",{"type":111,"coordinates":128},[129,130],13.40244,54.08905,{"lat":130,"lon":129},[133,137],{"name":134,"role":98,"phone":135,"phoneExt":62,"email":136},"Markus Blaurock, Dr.","0049 (0)3834 - 86 6202","markus.blaurock@med.uni-greifswald.de",{"name":134,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":139,"status":62,"city":140,"state":141,"zip":142,"country":108,"countryCode":109,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Uniklinik Köln","Cologne","North Rhine-Westphalia","50937",{"type":111,"coordinates":144},[145,146],6.95,50.93333,{"lat":146,"lon":145},[149,153],{"name":150,"role":98,"phone":151,"phoneExt":62,"email":152},"Malte Suchan, Dr.","0049 (0)221 478-4754","malte.suchan@uk-koeln.de",{"name":150,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":155,"status":62,"city":156,"state":141,"zip":157,"country":108,"countryCode":109,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Katholisches Krankenhaus Hagen","Hagen","58097",{"type":111,"coordinates":159},[160,161],7.47168,51.36081,{"lat":161,"lon":160},[164,168],{"name":165,"role":98,"phone":166,"phoneExt":62,"email":167},"Jonas JH Parker, Prof. Dr.","0041 (0)2331 805 5490","hno@kkh-hagen.de",{"name":169,"role":95,"phone":62,"phoneExt":62,"email":62},"Jonas JH Park, Prof. Dr.",{"facility":171,"status":62,"city":172,"state":173,"zip":174,"country":108,"countryCode":109,"cosmosGeoPoint":62,"geoPoint":62,"contacts":175},"Asklepios Klinik St. Georg Hamburg","Hamburg","Schleswig-Holstein","20099",[176,180],{"name":177,"role":98,"phone":178,"phoneExt":62,"email":179},"Silke Tribius, Prof. Dr.","0049 (0)40 1818852368","s.tribius@asklepios.com",{"name":177,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":182,"status":62,"city":183,"state":184,"zip":185,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University Hospital Basel","Basel","Canton of Basel-City","4031","Switzerland","CH",{"type":111,"coordinates":189},[190,191],7.57327,47.55839,{"lat":191,"lon":190},[194,196],{"name":94,"role":98,"phone":195,"phoneExt":62,"email":101},"0041 (0)61 328 78 97",{"name":94,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":198,"status":62,"city":199,"state":200,"zip":201,"country":186,"countryCode":187,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Seeland Cancer Center Biel","Biel\u002FBienne","Canton of Bern","2502",{"type":111,"coordinates":203},[204,205],7.24608,47.13713,{"lat":205,"lon":204},[208,212],{"name":209,"role":98,"phone":210,"phoneExt":62,"email":211},"Marco Siano, PD Dr.","0041 (0)32 327 08 08","seelandcancercenter@hin.ch",{"name":209,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":214,"status":62,"city":215,"state":216,"zip":217,"country":186,"countryCode":187,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"HOCH Health Ostschweiz","Sankt Gallen","Canton of St. Gallen","9007",{"type":111,"coordinates":219},[220,221],9.37477,47.42391,{"lat":221,"lon":220},[224,228],{"name":225,"role":98,"phone":226,"phoneExt":62,"email":227},"Markus Jörger, Prof. Dr.","0041 (0)71 494 29 22","markus.joerger@h-och.ch",{"name":225,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":230,"status":62,"city":231,"state":232,"zip":233,"country":186,"countryCode":187,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Universitätsspital Zürich","Zurich","Canton of Zurich","8091",{"type":111,"coordinates":235},[236,237],8.55,47.36667,{"lat":237,"lon":236},[240,244,245],{"name":241,"role":98,"phone":242,"phoneExt":62,"email":243},"Panagiotis Balermpas, Prof. Dr.","0041 (0)44 255 35 67","panagiotis.balermpas@usz.ch",{"name":62,"role":98,"phone":62,"phoneExt":62,"email":243},{"name":241,"role":95,"phone":62,"phoneExt":62,"email":62},{"facility":247,"status":62,"city":248,"state":249,"zip":250,"country":186,"countryCode":187,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Ente Ospedaliero Cantonale","Bellinzona","Canton Ticino","6500",{"type":111,"coordinates":252},[253,254],9.01703,46.19278,{"lat":254,"lon":253},[257,261],{"name":258,"role":98,"phone":259,"phoneExt":62,"email":260},"Vittoria Espeli, Dr.","0041 (0)91 811 79 00","segretariatoOncologia.OIL@eoc.ch",{"name":258,"role":95,"phone":62,"phoneExt":62,"email":62},{"type":263,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR",[265],{"name":266,"class":6},"Clinical Trial Unit, University Hospital Basel, Switzerland","100657735","phase-2-safety-and-efficacy-of-ruxolitinib-in-patients-with-hnscc-and-high-nlr-treated-with-pembrolizumab---the-phase-2-inflammastop-trial-100657735",false,"NCT07840456","Safety and Efficacy of Ruxolitinib in Patients With HNSCC and High NLR Treated With Pembrolizumab - The Phase 2 InflammaSTOP Trial","Safety and Efficacy of Ruxolitinib in Patients With Head and Neck Squamous Cell Carcinoma and High Neutrophil-to-Lymphocyte Ratio Treated With Pembrolizumab - The Phase 2 InflammaSTOP Trial","InflammaSTOP","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of R\u002FM HNSCC without local treatment options planned for treatment with pembrolizumab monotherapy (R\u002FM cohort) or locally advanced HNSCC planned for perioperative treatment with pembrolizumab (neoadjuvant cohort)\n* PD-L1 CPS≥1\n* ECOG-performance score 0-2\n* NLR \\>4 before start of pembrolizumab treatment\n* Signed and dated written informed consent\n\nExclusion Criteria:\n\n* Participation in another interventional study simultaneously and within the last 30 days prior to inclusion\n* Concurrent malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome\n* Active, known, or suspected autoimmune disease requiring systemic treatment, a concomitant therapy with systemic immune suppression, up to 5 mg\u002Fd prednisolone equivalent is allowed\n* Patients with severely reduced liver function (Child-Pugh Class C)\n* Known allergy or hypersensitivity reaction to ruxolitinib\n* Pregnancy and lactation\n* Any other serious or unstable medical condition that, in the Investigator's judgment, would compromise participant safety or interfere with study conduct; an active infection requiring systemic antimicrobial, antiviral, or antifungal therapy within 14 days before enrolment; or known HIV infection, active hepatitis B (HBsAg positive or detectable HBV DNA), or active hepatitis C (detectable HCV RNA)\n* Thrombocytopenia (platelet count \\\u003C100,000\u002FmicroL) or neutropenia (absolute neutrophil count \\\u003C1000\u002FmcroL)\n* Any condition that would require postponement of the planned curative surgical resection to accommodate the neoadjuvant ruxolitinib period (neoadjuvant cohort)\n* Anticipated inability to observe the minimum treatment-free interval of at least 48 hours between the last ruxolitinib dose and surgery (neoadjuvant cohort)","ALL","18 Years",{"count":278,"type":279},66,"ESTIMATED","INTERVENTIONAL",[282],"PHASE2","The goal of this Phase 2 clinical trial is to learn if adding ruxolitinib to pembrolizumab may improve treatment outcomes in patients with head and neck squamous cell carcinoma (HNSCC) who have increased levels of systemic inflammation before treatment, as measured by the neutrophil-to-lymphocyte ratio (NLR). The investigational drug will be used outside of its approved indication (off-label use) based on its known pharmacologic mechanism and prior clinical experience in patients with myeloproliferative neoplasms and graft-versus-host disease.\n\nThe main questions it aims to answer are:\n\nIs treatment with ruxolitinib in combination with pembrolizumab safe and well tolerated? Can the addition of ruxolitinib improve treatment outcomes compared with historical data? How does ruxolitinib affect the immune system and inflammation when given together with pembrolizumab? How does the combination treatment affect patients' quality of life?\n\nParticipants will:\n\nReceive treatment with pembrolizumab and intermittent ruxolitinib. Undergo blood tests to assess immune responses and inflammation. Attend study visits for safety assessments and treatment monitoring. Complete quality-of-life questionnaires, where applicable.\n\nThe results of this study will help researchers better understand how inflammation and the body's immune system affect treatment outcomes in people with head and neck cancer. The findings may also help improve the design of future studies investigating new treatment combinations for this disease.",[285],"Carcinoma, Squamous Cell of Head and Neck HNSCC",[287,288,289,87,81,290,291,292,293,294],"Head and Neck Squamous Cell Carcinoma","HNSCC","Recurrent and Metastatic Head and Neck Cancer","Janus Kinase Inhibitors","JAK Inhibition","Inflammatory Biomarkers","Immunotherapy","Neutrophil-to-lymphocyte ratio","NOT_YET_RECRUITING","2026-09-18",{"date":298,"type":299},"2026-09-25","ACTUAL",{"date":301,"type":279},"2026-11",{"date":303,"type":279},"2029-02",{"name":5,"class":6},10]