[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643662":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":26,"locations":11,"responsibleParty":32,"collaborators":11,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":11,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":11},{"fullName":5,"class":6},"Centre Antoine Lacassagne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Residual Pembrolizumab Exposure Assessment","EXPERIMENTAL",null,[13,14],"Biological: Blood sampling","Procedure: Tumor biopsies for biobank establishment (optional)",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"BIOLOGICAL","Blood sampling","Patients will be followed according to standard clinical care. Biological samples collected include: (1) pharmacokinetic and extracellular vesicle analyses: 10 mL blood samples in EDTA tubes at 21±3, 35±3, 49±3, and 63±3 days after the last pembrolizumab administration (P1-P4); (2) pharmacogenetic analysis: one baseline 5 mL EDTA blood sample; (3) cytokine and immune cell analyses: at P1 and P4, collection of 2×4 mL lithium heparin tubes, 1×10 mL EDTA tube, and 1×5 mL dry tube.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"PROCEDURE","Tumor biopsies for biobank establishment (optional)","Depending on feasibility of the procedure, and at the discretion of the investigator, two biopsies will be performed in 20 consenting patients:\n\n* Biopsy B1: between the last administration of pembrolizumab (Day 0) and before initiation of standard salvage chemotherapy,\n* Biopsy B2: after initiation of salvage chemotherapy, at Day 63 ± 7 days after the last administration of pembrolizumab. If chemotherapy is discontinued prematurely, Biopsy B2 may only be performed if the patient has received at least 3 weeks of chemotherapy exposure.\n\nDue to logistical constraints, these biopsies will be proposed to patients followed at CAL. They will be performed primarily in the interventional radiology department of CAL.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Marine SIRVENT","CONTACT","+33 4 92 03 17 78","DRCI-Promotion@nice.unicancer.fr",{"type":33,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100643662","phase-4-pharmacokinetic-study-of-pembrolizumab-and-its-impact-on-immunity-and-the-tumor-microenvironment-which-may-explain-the-efficacy-of-post-immunotherapy-chemotherapy-100643662",false,"NCT07633613","Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.","CPI","Inclusion Criteria:\n\n\\- Patients over 18 years of age\n\n\\- Patients diagnosed with :\n\n1. Non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma.\n2. Head and neck squamous cell carcinoma, p16-negative for oropharyngeal tumors.\n\n   * Recurrent and\u002For metastatic tumor not amenable to curative locoregional treatment.\n   * Disease progression under Pembrolizumab immunotherapy, administered at the standard dose of 200 mg every 3 weeks, as first-line treatment for metastatic disease, regardless of the number of cycles received, either as monotherapy or in combination with chemotherapy, as defined below:\n\n     • For pulmonary adenocarcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) and Pemetrexed\n\n   ii. Maintenance therapy with Pembrolizumab, with or without Pemetrexed.\n\n   • For pulmonary squamous cell carcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin) and Paclitaxel\n\n   +\u002F- ii. Maintenance therapy with Pembrolizumab alone.\n\n   • For head and neck squamous cell carcinomas : i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) ± 5-Fluorouracil (5-FU) or Paclitaxel\n\n   +\u002F- ii. Maintenance therapy with Pembrolizumab alone.\n   * Eligibility for salvage chemotherapy within standard care:\n\n     • For pulmonary adenocarcinomas: weekly Paclitaxel, with or without Bevacizumab.\n     * For pulmonary squamous cell carcinomas: Gemcitabine monotherapy.\n     * For head and neck squamous cell carcinomas: weekly Paclitaxel and\u002For Cetuximab. Standard salvage chemotherapy may be initiated between Day 18 and Day 35 following the last Pembrolizumab injection, at standard doses.\n   * Measurable disease according to RECIST 1.1 criteria.\n   * Performance status (PS) 0 to 2.\n   * Baseline laboratory results meeting the usual criteria permitting initiation of salvage chemotherapy.\n   * Patients who has voluntarily agreed to participate in the study (including additional blood sampling) and has signed the informed consent form.\n   * For the subpopulation with accessible tissue biopsy:\n\n     * Patient agrees to undergo biopsy,\n     * INR \\\u003C 1.5, Platelets \\> 50000\u002FμL.\n   * Patients covered by a social security health insurance scheme.\n\n   Exclusion Criteria:\n   * History of cancer, except for cancers in complete remission for more than 3 years, fully resected cutaneous basal cell carcinomas, or treated carcinoma in situ or cervical intraepithelial neoplasia (in situ cervical epithelioma),\n   * Patients participating in another clinical trial for which an exclusion period is specified,\n   * Minor patients,\n   * For the subpopulation with accessible tissue biopsy, patients receiving:\n\n     • Clopidogrel (hydrogen sulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) without the possibility of discontinuation for 5 days,\n\n     • Low-molecular-weight heparin (LMWH) without the possibility of dose suspension prior to the procedure,\n\n     • Or Fondaparinux without the possibility of discontinuation,\n\n     • Or Abciximab without the possibility of discontinuation for 24 hours and aPTT \\\u003C 50s and ACT \\\u003C 150s,\n\n     • Or Eptifibatide or Tirofiban hydrochloride monohydrate or Argatroban without the possibility of discontinuation 4 hours before the procedure,\n     * Or Bivalirudin without the possibility of discontinuation 2-3 hours before the procedure if CrCL \\> 50 mL\u002Fmin, or 3-5 hours if CrCL \\\u003C 50 mL\u002Fmin,\n     * Or Dabigatran etexilate without the possibility of discontinuation 2-3 days before the procedure if CrCL \\> 50 mL\u002Fmin, or 3-5 days if CrCL \\\u003C 50 mL\u002Fmin.\n   * Vulnerable persons as defined in Articles L1121-5 to L1121-8 :\n\n     • Pregnant women, women in labour, and breastfeeding mothers,\n     * Persons deprived of liberty by judicial or administrative decision, and persons hospitalized without consent under Articles L3212-1 and L3213-1 who do not fall under the provisions of Article L1121-8,\n     * Persons admitted to a health or social care institution for purposes other than research,\n     * Adults under legal protection measures or unable to express their consent.","ALL","18 Years",{"count":44,"type":45},110,"ESTIMATED","INTERVENTIONAL",[48],"PHASE4","This is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and\u002For metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative local treatment.",[51,52],"Non-Small Cell Lung Carcinoma (NSCLC)","Metastatic Head and Neck Squamous Cell Carcinoma",[54,55,56,57],"Pembrolizumab","immunotherapy","salvage chemotherapy","pharmacokinetics","NOT_YET_RECRUITING","2026-06-04",{"date":61,"type":62},"2026-06-08","ACTUAL",{"date":64,"type":45},"2026-07",{"date":66,"type":45},"2028-12",{"name":5,"class":6}]