[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma-of-the-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma-of-the-skin":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100431035","clinical-benefit-and-biomarker-analysis-of-combination-of-pd-1pd-l1-immune-checkpoint-inhibitors-and-radiotherapy-100431035",false,"NCT04892849","Clinical Benefit and Biomarker Analysis of Combination of PD-1\u002FPD-L1 Immune Checkpoint Inhibitors and Radiotherapy","Clinical Benefit and Biomarker Analysis of Combination of PD-1\u002FPD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors","ST-ICI02","Inclusion Criteria:\n\n* Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or \"other solid tumour\"\n* Indication for system therapy with a PD-1\u002FPD-L1 inhibitor according to clinical standards\n* Patients without or with radiation of one or more metastases\n* Age at least 18 years\n\nExclusion Criteria:\n\n* Melanoma patients\n* Fertile patients who refuse effective contraception during study treatment\n* Persistent drug and\u002For alcohol abuse\n* Patients not able or willing to behave according to study protocol\n* Patients in care\n* Patients that are not able to speak German\n* Patients which are imprisoned according to legal or governmental order\n\nBoth gender are included into the study, a maximum age was not defined.","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Inhibitors of the programmed cell death protein 1 (PD-1)\u002FPD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1\u002FPD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and \"other solid tumors\" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin \\[depending on the current drug approval\\]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects",[25,26,27,28,29,30,31],"HNSCC","NSCLC","Esophageal Cancer","Urothelial Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma of the Skin","Small Cell Bronchial Carcinomas",[33,34],"Immunotherapy","Radiotherapy","RECRUITING","2025-09-10",{"date":38,"type":39},"2025-09-17","ACTUAL",{"date":41,"type":39},"2021-04-30",{"date":43,"type":21},"2030-12-31",{"name":45,"class":46},"University of Erlangen-Nürnberg Medical School","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100378229","phase-2-nivolumab-for-treatment-of-squamous-cell-carcinoma-of-the-skin-100378229","NCT04204837","Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin","Phase II Study of Nivolumab (Group 1) and Nivolumab Plus Relatlimab (Group 2) in Patients With Locally Advanced\u002F Metastatic Squamous Cell Carcinoma of the Skin","Inclusion Criteria:\n\n1. Men and women, 18 years of age and older on day of signing written informed consent\n2. Histologically or cytologically documented locally-advanced and\u002For metastatic squamous cell carcinoma of the skin (stage III\u002FIV AJCC 2010) that is incurable\n3. Archival tumor tissue available for evaluation of PD-L1 and LAG-3 expression\n4. Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n5. Life expectancy of at least 12 weeks\n6. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2\n7. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration:\n\n   * WBC ≥ 2000\u002Fμl\n   * Neutrophils ≥ 1500\u002FμL\n   * Platelets ≥ 100 x103\u002FμL\n   * Hemoglobin \\> 9.0 g\u002FdL\n   * Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (if using the Cockcroft-Gault formula below):\n\n   Female CrCl = (140 - age in years) x weight in kg x 0.85\u002F72 x serum creatinine in mg\u002FdL Male CrCl = (140- age in years) x weight in kg x 1.00\u002F72 x serum creatinine in mg\u002FdL\n   * AST\u002FALT ≤ 3 x ULN\n   * Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n   * Negative pregnancy test and effective contraception (Pearl-Index \\\u003C1) for for women of childbearing potential (WOCBP) if the risk of conception exists\n8. Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration\n9. Prior systemic antibiotic treatment must have been completed at least 30 days prior to stool sample collection\n\nExclusion Criteria:\n\n1. Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n2. Prior therapy with CTLA-4, PD-1 or LAG-3 antibodies\n3. History of myocarditis, regardless of etiology\n4. Troponin T (TnT) or I (TnI) \\> 2× institutional upper limit of normal (ULN). Participants with TnT or TnI levels between \\> 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. If TnT or TnI levels are between \\> 1× to 2× ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit\u002Frisk assessment by the Investigator. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2× ULN, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit\u002Frisk assessment by the Investigator\n5. A condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n6. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n7. Known additional malignancy that is progressing or requires active treatment. Patients with chronic lymphocytic leukemia that is stable under active therapy are eligible for inclusion.\n8. An active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n9. Patients with serious intercurrent illness, requiring hospitalization\n10. Other serious illnesses, e.g. serious infections requiring antibiotics\n11. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n12. Pregnancy (absence to be confirmed by ß-HCG urinary test, minimum sensitivity 25 IU\u002FL or equivalent units of HCG)) or lactation period\n13. Women of childbearing potential (WOCBP): Refusal or inability to use effective means of contraception (Pearl-Index \\\u003C1)\n14. History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n15. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection\n16. 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\n17. Known hypersensitivity reaction to any of the components of study treatment",{"count":56,"type":21},61,"INTERVENTIONAL",[59],"PHASE2","To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in patients with locally advanced\u002Fmetastatic squamous cell carcinoma of the skin using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment (Time Frame Group 2: From first dose up to 5 years)",[30],[63,64],"Nivolumab","Relatlimab","2024-04-17",{"date":67,"type":39},"2024-04-18",{"date":69,"type":39},"2017-03-06",{"date":71,"type":21},"2027-12",{"name":73,"class":46},"Salzburger Landeskliniken",7]