[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564090":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":56,"locations":62,"responsibleParty":219,"collaborators":34,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":34,"eligibilityCriteria":227,"healthyVolunteers":223,"sex":228,"minAge":229,"maxAge":34,"enrollmentInfo":230,"targetDuration":34,"studyType":233,"phases":234,"briefSummary":237,"conditions":238,"keywords":243,"overallStatus":65,"whyStopped":34,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Linnaeus Therapeutics, Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"LNS8801 Monotherapy","EXPERIMENTAL","125 mg LNS8801 by mouth every day",[13],"Biological: LNS8801",{"label":15,"type":10,"description":16,"interventionNames":17},"LNS8801 + Pembrolizumab","125 mg LNS8801 by mouth every day plus 200 mg Pembrolizumab by IV infusion once every 3 weeks.",[13,18],"Biological: Pembrolizumab",{"label":20,"type":21,"description":22,"interventionNames":23},"Physician's Choice","ACTIVE_COMPARATOR","patients may receive chemotherapy or immunotherapy as determined by physician.",[24,25,26,27],"Drug: Chemotherapy (dacarbazine or temozolomide)","Biological: Immunotherapy (Pembrolizumab)","Biological: Immunotherapy (nivolumab and relatlimab)","Biological: Immunotherapy (ipilimumab and nivolumab)",[29,35,39,44,48,52],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","LNS8801","G protein-coupled estrogen receptor (GPER) agonist",[15,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Pembrolizumab","Recombinant monoclonal antibody (anti-PD1)",[15],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"DRUG","Chemotherapy (dacarbazine or temozolomide)","chemotherapy (dacarbazine, temozolomide)",[20],{"type":30,"name":45,"description":46,"armGroupLabels":47,"otherNames":34},"Immunotherapy (Pembrolizumab)","pembrolizumab",[20],{"type":30,"name":49,"description":50,"armGroupLabels":51,"otherNames":34},"Immunotherapy (nivolumab and relatlimab)","nivolumab and relatlimab",[20],{"type":30,"name":53,"description":54,"armGroupLabels":55,"otherNames":34},"Immunotherapy (ipilimumab and nivolumab)","ipilimumab and nivolumab",[20],[57],{"name":58,"role":59,"phone":60,"phoneExt":34,"email":61},"Sudha Velayutham","CONTACT","210-563-8441","svelayutham@lumabridge.com",[63,86,103,119,136,150,165,183,201],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"USC Newport Beach","RECRUITING","Newport Beach","California","92663","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-117.92895,33.61891,{"lat":75,"lon":74},[78,82],{"name":79,"role":59,"phone":80,"phoneExt":34,"email":81},"Samantha Kwan","323-365-3399","Samantha.kwan@med.usc.edu",{"name":83,"role":59,"phone":84,"phoneExt":34,"email":85},"Sandy Tran","323-365-3935","sandy.tran@med.usc.edu",{"facility":87,"status":65,"city":88,"state":67,"zip":89,"country":69,"countryCode":70,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"UCSF","San Francisco","94143",{"type":72,"coordinates":91},[92,93],-122.41942,37.77493,{"lat":93,"lon":92},[96,100],{"name":97,"role":59,"phone":98,"phoneExt":34,"email":99},"Katy Tsai","323-865-3000","Katy.Tsai@ucsf.edu",{"name":101,"role":59,"phone":34,"phoneExt":34,"email":102},"Michael Wong","Michael.Wong2@ucsf.edu",{"facility":104,"status":65,"city":104,"state":67,"zip":105,"country":69,"countryCode":70,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Stanford","94305",{"type":72,"coordinates":107},[108,109],-122.16608,37.42411,{"lat":109,"lon":108},[112,116],{"name":113,"role":59,"phone":114,"phoneExt":34,"email":115},"V Dingankar","650-724-5519","vaidehid@stanford.edu",{"name":117,"role":59,"phone":34,"phoneExt":34,"email":118},"Lucie Cutler","luciecut@stanford.edu",{"facility":120,"status":65,"city":121,"state":122,"zip":123,"country":69,"countryCode":70,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"University of Colorado Anschutz","Aurora","Colorado","80045",{"type":72,"coordinates":125},[126,127],-104.83192,39.72943,{"lat":127,"lon":126},[130,133],{"name":131,"role":59,"phone":98,"phoneExt":34,"email":132},"Sapna Patel","Sapna.p.patel@cuanschutz.edu",{"name":134,"role":59,"phone":34,"phoneExt":34,"email":135},"Zackry Morgan","zackry.morgan@cuanschutz.edu",{"facility":137,"status":65,"city":138,"state":122,"zip":139,"country":69,"countryCode":70,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"University of Colorado","Denver","80204",{"type":72,"coordinates":141},[142,143],-104.9847,39.73915,{"lat":143,"lon":142},[146],{"name":147,"role":59,"phone":148,"phoneExt":34,"email":149},"Kathy Prinz","303-724-8822","MelanomaClinicalResearch@olucdenver.onmicrosoft.com",{"facility":151,"status":65,"city":152,"state":153,"zip":154,"country":69,"countryCode":70,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Moffitt Cancer Center","Tampa","Florida","87535",{"type":72,"coordinates":156},[157,158],-82.45843,27.94752,{"lat":158,"lon":157},[161],{"name":162,"role":59,"phone":163,"phoneExt":34,"email":164},"Indra Heron","813-745-4482","Indra.Herron@Moffitt.org",{"facility":166,"status":65,"city":167,"state":168,"zip":169,"country":69,"countryCode":70,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Dana Farber","Boston","Massachusetts","02215",{"type":72,"coordinates":171},[172,173],-71.05977,42.35843,{"lat":173,"lon":172},[176,180],{"name":177,"role":59,"phone":178,"phoneExt":34,"email":179},"Justine Cohen","917.710.6968","justine_cohen@dfci.harvard.edu",{"name":181,"role":59,"phone":34,"phoneExt":34,"email":182},"Linnea Drew","linneam_drew@dfci.harvard.edu",{"facility":184,"status":65,"city":185,"state":186,"zip":187,"country":69,"countryCode":70,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University of New Mexico","Albuquerque","New Mexico","87106",{"type":72,"coordinates":189},[190,191],-106.65114,35.08449,{"lat":191,"lon":190},[194,198],{"name":195,"role":59,"phone":196,"phoneExt":34,"email":197},"Moises Turquie","505-272-4946","MHarariTurquie@salud.unm.edu",{"name":199,"role":59,"phone":34,"phoneExt":34,"email":200},"Mollie K Dedig","mdedig@salud.unm.edu",{"facility":202,"status":65,"city":203,"state":204,"zip":205,"country":69,"countryCode":70,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"UPenn","Philadelphia","Pennsylvania","19107",{"type":72,"coordinates":207},[208,209],-75.16362,39.95238,{"lat":209,"lon":208},[212,216],{"name":213,"role":59,"phone":214,"phoneExt":34,"email":215},"Tara Mitchell","215-662-7908","Tara.Mitchell@pennmedicine.upenn.edu",{"name":217,"role":59,"phone":34,"phoneExt":34,"email":218},"Carrie Bosse","Carrie.Bosse@Pennmedicine.upenn.edu",{"type":220,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100564090","phase-2-a-trial-of-lns8801-with-or-without-pembrolizumab-in-patients-with-refractory-melanoma-100564090",false,"NCT06624644","A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma","A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma","Inclusion Criteria:\n\n* Confirmed unresectable and\u002For metastatic cutaneous melanoma.\n* 2 copies of the fully functional form of GPER protein-coding sequence.\n* Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.\n* Able to swallow tablets.\n* Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.\n* Received an anti-CTLA-4 and\u002For BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and\u002For BRAF therapy prior to and for this study.\n* Measurable disease.\n* Eastern Cooperative Oncology Group Performance Status of 0 to 1.\n\nExclusion Criteria:\n\n* Blue nevus subtype, mucosal, acral lentiginous, or uveal\u002Focular\u002Fchoroidal Melanoma.\n* Previous anti-cancer or investigational drug\u002Fdevice treatment within 4 weeks of the first dose of study drug.\n* Radiotherapy within 2 weeks of starting study drug.\n* Allogeneic tissue\u002Fsolid organ transplant.\n* Unstable autoimmune or immunodeficiency disease.\n* Other concurrent health issues that would make participation or completion of the study difficult.\n* Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":231,"type":232},135,"ESTIMATED","INTERVENTIONAL",[235,236],"PHASE2","PHASE3","The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor.\n\n135 patients will be randomly (like flipping a coin) placed in 3 treatment groups.\n\nIn the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years.\n\nIn the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years.\n\nIn the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab\u002Frelatlimab or nivolumab\u002Fipilimumab) as determined by their treating physician.\n\nHow often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.",[239,240,241,242],"Melanoma (Skin Cancer)","Melanoma Stage IIIB-IV","Cutaneous Melanoma","Unresectable Melanoma",[244],"Melanoma","2026-04-18",{"date":247,"type":248},"2026-04-22","ACTUAL",{"date":250,"type":248},"2025-08-06",{"date":252,"type":232},"2031-02",{"name":5,"class":6},9]