[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565019":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":108,"centralContacts":113,"locations":124,"responsibleParty":154,"collaborators":157,"id":161,"slug":118,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":118,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":118,"enrollmentInfo":169,"targetDuration":118,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":118,"overallStatus":127,"whyStopped":118,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (lovastatin, pembrolizumab)","EXPERIMENTAL","Patients receive lovastatin PO QD and pembrolizumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, and CT, MRI or PET\u002FCT throughout the study.",[13,14,15,16,17,18],"Procedure: Biospecimen Collection","Procedure: Computed Tomography","Drug: Lovastatin","Procedure: Magnetic Resonance Imaging","Biological: Pembrolizumab","Procedure: Positron Emission Tomography",[20,29,44,54,74,95],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9],[26,27,28],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Computed Tomography","Undergo CT or PET\u002FCT",[9],[34,35,36,37,38,39,40,41,42,43],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Lovastatin","Given PO",[9],[50,51,52,53],"Lovastatin Sodium","Mevacor","Mevinolin","Monacolin K",{"type":21,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Magnetic Resonance Imaging","Undergo MRI",[9],[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"BIOLOGICAL","Pembrolizumab","Given IV",[9],[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"BCD-201","GME 751","GME751","Keytruda","Lambrolizumab","MK 3475","MK-3475","MK3475","Pembrolizumab Biosimilar BCD-201","Pembrolizumab Biosimilar GME751","Pembrolizumab Biosimilar QL2107","QL2107","SCH 900475","SCH-900475","SCH900475",{"type":21,"name":96,"description":97,"armGroupLabels":98,"otherNames":99},"Positron Emission Tomography","Undergo PET\u002FCT",[9],[100,101,102,103,104,105,106,107],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",[109],{"name":110,"affiliation":111,"role":112},"Nicole C Schmitt, D, FACS","Emory University Hospital\u002FWinship Cancer Institute","PRINCIPAL_INVESTIGATOR",[114,120],{"name":115,"role":116,"phone":117,"phoneExt":118,"email":119},"Nicole C. Schmitt, MD, FACS","CONTACT","404-778-0278",null,"nicole.cherie.schmitt@emory.edu",{"name":121,"role":116,"phone":122,"phoneExt":118,"email":123},"Nabil F Saba, MD, FACP","404-778-1900","nfsaba@emory.edu",[125,145],{"facility":126,"status":127,"city":128,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":139},"Emory University Hospital Midtown","RECRUITING","Atlanta","Georgia","30308","United States","US",{"type":134,"coordinates":135},"Point",[136,137],-84.38798,33.749,{"lat":137,"lon":136},[140,144],{"name":141,"role":116,"phone":142,"phoneExt":118,"email":143},"Ardith Deshay","404-686-1858","ardith.deshay.deshay@emory.edu",{"name":115,"role":112,"phone":118,"phoneExt":118,"email":118},{"facility":111,"status":127,"city":128,"state":129,"zip":146,"country":131,"countryCode":132,"cosmosGeoPoint":147,"geoPoint":149,"contacts":150},"30322",{"type":134,"coordinates":148},[136,137],{"lat":137,"lon":136},[151,153],{"name":152,"role":116,"phone":142,"phoneExt":118,"email":143},"Ardith C. Deshay",{"name":115,"role":112,"phone":118,"phoneExt":118,"email":118},{"type":112,"investigatorFullName":155,"investigatorTitle":156,"investigatorAffiliation":5,"oldNameTitle":118,"oldOrganization":118},"Nicole Schmitt","Principal Investigator",[158],{"name":159,"class":160},"National Cancer Institute (NCI)","NIH","100565019",false,"NCT06636734","Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial","A Phase II Trial Of Lovastatin And Pembrolizumab In Patients With RM HNSCC (LAPP)","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can be included if human papillomavirus (HPV)-positive\n* PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)\n* Patients must not be under consideration for salvage surgery\n* Measurable disease by RECIST 1.1 criteria\n* Life expectancy of more than 3 months, as determined by the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 from toxicities related to any prior treatments, unless adverse events are clinically non-significant and\u002For stable on supportive therapy\n* For men or women of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of lovastatin\u002Fpembrolizumab administration\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 without colony stimulating factor support\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002FdL\n* Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL\n* Serum albumin ≥ 2.8 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN\n* Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)\n\nExclusion Criteria:\n\n* Patients already taking a statin drug\n* Liver dysfunction precluding the use of statins\n* Radiation to the head and neck or other sites within 4 weeks prior to enrollment\n* Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment\n* Prior treatment with immune checkpoint blocking therapy\n* Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)\n* Pregnancy, lactation, or plan to become pregnant\n* Inability to swallow lovastatin tablets\n* Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab","ALL","18 Years",{"count":170,"type":171},28,"ESTIMATED","INTERVENTIONAL",[174],"PHASE2","This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.",[177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198],"Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Nasopharyngeal Squamous Cell Carcinoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Metastatic Paranasal Sinus Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Nasopharyngeal Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Recurrent Paranasal Sinus Squamous Cell Carcinoma","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Sinonasal Cancer AJCC v8","2026-02-08",{"date":201,"type":202},"2026-02-11","ACTUAL",{"date":204,"type":202},"2024-12-09",{"date":206,"type":171},"2028-12-31",{"name":5,"class":6},2]