[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06961006":3,"trial-entities:NCT06961006":524,"trial-summary:NCT06961006":528},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":53,"secondary_outcomes":58,"sex":77,"minimum_age":78,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":100,"locations":103,"central_contacts":507,"overall_officials":512,"references":516,"see_also_links":517},"NCT06961006","V940-012","A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012\u002FINTerpath-012)","A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)","RECRUITING","2031-09-05","2026-07","2026-07-02","2025-05-29","Merck Sharp & Dohme LLC","INDUSTRY",false,"Researchers want to learn if intismeran autogene with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Intismeran autogene is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy.\n\nThe goal of this study is to learn if people who receive intismeran autogene with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.",null,[19],"Malignant Melanoma",[21,22,23],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},160,"ESTIMATED",[32,41,49],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"BIOLOGICAL","Intismeran autogene","IM injection",[37],"Intismeran autogene + Pembrolizumab",[39,40],"mRNA-4157","V940",{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"Pembrolizumab","IV infusion",[37,45],"Placebo + Pembrolizumab",[47,48],"MK-3475","KEYTRUDA®",{"type":50,"name":51,"description":35,"armGroupLabels":52},"OTHER","Placebo",[45],[54],{"measure":55,"description":56,"timeFrame":57},"Progression-free Survival (PFS)","PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by investigator assessment or death due to any cause, whichever occurs first. Progressive disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 as assessed by investigator will be presented.","Up to approximately 36 months",[59,63,66,69,73],{"measure":60,"description":61,"timeFrame":62},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR per RECIST 1.1 as assessed by investigator will be presented.","Up to approximately 6 years",{"measure":64,"description":65,"timeFrame":62},"Duration of Response (DOR)","For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.",{"measure":67,"description":68,"timeFrame":62},"Overall Survival (OS)","OS is defined as time from randomization to death due to any cause.",{"measure":70,"description":71,"timeFrame":72},"Number of Participants With ≥1 Adverse Event (AE)","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported.","Up to approximately 27 months",{"measure":74,"description":75,"timeFrame":76},"Number of Participants Discontinuing From Study Therapy Due to AE","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported.","Up to approximately 24 months","ALL","18 Years",{"inclusion":80,"exclusion":89,"raw_text":99},[81,82,83,84,85,86,87,88],"Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.","Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein \\[CTLA-4\\], anti-programmed cell death 1 protein \\[PD-1\\] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation.","Have documentation of serine\u002Fthreonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible).","Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator\u002Fradiology assessment.","Provides tumor tissue (preferably from a metastatic site and, if not available, from the primary tumor) that is suitable for next generation sequencing and biomarker analysis as required for this study.","Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral therapy (ART).","Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.","Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.",[90,91,92,93,94,95,96,97,98],"Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator.","HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.","Has ocular or mucosal melanoma.","Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the Screening blood sample (including the blood sample for V940 generation).","Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, lymphocyte activation gene 3 \\[LAG-3\\], tumor necrosis factor receptors \\[OX-40 or CD137\\]), with some exceptions.","Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.","Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.","Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.","Received prior treatment with another universal or personalized cancer vaccine.","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein \\[CTLA-4\\], anti-programmed cell death 1 protein \\[PD-1\\] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation.\n* Have documentation of serine\u002Fthreonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible).\n* Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator\u002Fradiology assessment.\n* Provides tumor tissue (preferably from a metastatic site and, if not available, from the primary tumor) that is suitable for next generation sequencing and biomarker analysis as required for this study.\n* Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral therapy (ART).\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has ocular or mucosal melanoma.\n* Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the Screening blood sample (including the blood sample for V940 generation).\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, lymphocyte activation gene 3 \\[LAG-3\\], tumor necrosis factor receptors \\[OX-40 or CD137\\]), with some exceptions.\n* Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.\n* Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Received prior treatment with another universal or personalized cancer vaccine.",[101,102],"ADULT","OLDER_ADULT",[104,118,129,140,151,162,174,184,195,207,217,229,240,250,262,273,284,294,304,316,323,333,344,354,364,374,386,396,406,416,427,439,450,462,469,479,490,497],{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":109,"contacts":110,"geoPoint":115},"Highlands Oncology Group ( Site 4042)","Springdale","Arkansas","72762","United States",[111],{"name":112,"role":113,"phone":114},"Study Coordinator","CONTACT","479-872-8130",{"lat":116,"lon":117},36.18674,-94.12881,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":109,"contacts":123,"geoPoint":126},"UCSF Medical Center at Mission Bay ( Site 4044)","San Francisco","California","94158",[124],{"name":112,"role":113,"phone":125},"877-827-3222",{"lat":127,"lon":128},37.77493,-122.41942,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":109,"contacts":134,"geoPoint":137},"John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047)","Hackensack","New Jersey","07601",[135],{"name":112,"role":113,"phone":136},"551-996-1777",{"lat":138,"lon":139},40.88593,-74.04347,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":109,"contacts":145,"geoPoint":148},"Inova Schar Cancer Institute ( Site 4046)","Fairfax","Virginia","22031",[146],{"name":112,"role":113,"phone":147},"571-472-0237",{"lat":149,"lon":150},38.84622,-77.30637,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":109,"contacts":156,"geoPoint":159},"Fred Hutchinson Cancer Center ( Site 4041)","Seattle","Washington","98109",[157],{"name":112,"role":113,"phone":158},"206-606-7341",{"lat":160,"lon":161},47.60621,-122.33207,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":167,"contacts":168,"geoPoint":171},"Blacktown Hospital ( Site 2001)","Blacktown","New South Wales","2148","Australia",[169],{"name":112,"role":113,"phone":170},"+61298818000",{"lat":172,"lon":173},-33.76667,150.91667,{"facility":175,"status":8,"city":176,"state":165,"zip":177,"country":167,"contacts":178,"geoPoint":181},"Melanoma Institute Australia ( Site 2000)","Wollstonecraft","2065",[179],{"name":112,"role":113,"phone":180},"+61299117200",{"lat":182,"lon":183},-33.8328,151.18981,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":167,"contacts":189,"geoPoint":192},"One Clinical Research ( Site 2002)","Nedlands","Western Australia","6009",[190],{"name":112,"role":113,"phone":191},"+61 8 6279 9466",{"lat":193,"lon":194},-31.98184,115.8073,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":200,"contacts":201,"geoPoint":204},"William Osler Health System (Brampton Civic Hospital) ( Site 2023)","Brampton","Ontario","L6R 3J7","Canada",[202],{"name":112,"role":113,"phone":203},"6472054387",{"lat":205,"lon":206},43.68341,-79.76633,{"facility":208,"status":8,"city":209,"state":198,"zip":210,"country":200,"contacts":211,"geoPoint":214},"Sunnybrook Research Institute ( Site 2022)","Toronto","M4N 3M5",[212],{"name":112,"role":113,"phone":213},"4164804757",{"lat":215,"lon":216},43.70643,-79.39864,{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":222,"contacts":223,"geoPoint":226},"Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2042)","Nice","Alpes-Maritimes","06202","France",[224],{"name":112,"role":113,"phone":225},"+33492036667",{"lat":227,"lon":228},43.70313,7.26608,{"facility":230,"status":8,"city":231,"state":232,"zip":233,"country":222,"contacts":234,"geoPoint":237},"Hôpital Saint-Louis ( Site 2041)","Paris","Île-de-France Region","75010",[235],{"name":112,"role":113,"phone":236},"+33142499961",{"lat":238,"lon":239},48.85341,2.3488,{"facility":241,"status":8,"city":242,"state":232,"zip":243,"country":222,"contacts":244,"geoPoint":247},"Gustave Roussy ( Site 2040)","Villejuif","94800",[245],{"name":112,"role":113,"phone":246},"+33142114211",{"lat":248,"lon":249},48.7939,2.35992,{"facility":251,"status":8,"city":252,"state":253,"zip":254,"country":255,"contacts":256,"geoPoint":259},"NCT ( Site 2065)","Heidelberg","Baden-Wurttemberg","69120","Germany",[257],{"name":112,"role":113,"phone":258},"+496221568562",{"lat":260,"lon":261},49.40768,8.69079,{"facility":263,"status":8,"city":264,"state":265,"zip":266,"country":255,"contacts":267,"geoPoint":270},"Universitätsklinikum Frankfurt Goethe-Universität ( Site 2063)","Frankfurt am Main","Hesse","60590",[268],{"name":112,"role":113,"phone":269},"+496963015311",{"lat":271,"lon":272},50.11552,8.68417,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":255,"contacts":278,"geoPoint":281},"Universitaetsklinikum Koeln ( Site 2064)","Cologne","North Rhine-Westphalia","50937",[279],{"name":112,"role":113,"phone":280},"00491737057524",{"lat":282,"lon":283},50.93333,6.95,{"facility":285,"status":8,"city":286,"state":276,"zip":287,"country":255,"contacts":288,"geoPoint":291},"Universitaetsklinikum Essen ( Site 2061)","Essen","45147",[289],{"name":112,"role":113,"phone":290},"00492017232431",{"lat":292,"lon":293},51.45657,7.01228,{"facility":295,"status":8,"city":296,"zip":297,"country":255,"contacts":298,"geoPoint":301},"Universitaetsklinikum Hamburg-Eppendorf ( Site 2060)","Hamburg","20251",[299],{"name":112,"role":113,"phone":300},"00494074100",{"lat":302,"lon":303},53.55073,9.99302,{"facility":305,"status":8,"city":306,"state":307,"zip":308,"country":309,"contacts":310,"geoPoint":313},"General Hospital of Athens \"Laiko\" ( Site 2080)","Athens","Attica","115 27","Greece",[311],{"name":112,"role":113,"phone":312},"0030 2132060954",{"lat":314,"lon":315},37.98376,23.72784,{"facility":317,"status":8,"city":306,"state":307,"zip":318,"country":309,"contacts":319,"geoPoint":322},"Metropolitan Hospital ( Site 2082)","18547",[320],{"name":112,"role":113,"phone":321},"0030 2104809739",{"lat":314,"lon":315},{"facility":324,"status":8,"city":325,"zip":326,"country":309,"contacts":327,"geoPoint":330},"European Interbalkan Medical Center ( Site 2081)","Thessaloniki","570 01",[328],{"name":112,"role":113,"phone":329},"0030 2310400213",{"lat":331,"lon":332},40.64072,22.93493,{"facility":334,"status":8,"city":335,"zip":336,"country":337,"contacts":338,"geoPoint":341},"HaEmek Medical Center ( Site 3003)","Afula","1834111","Israel",[339],{"name":112,"role":113,"phone":340},"+972-4-6494000",{"lat":342,"lon":343},32.60907,35.2892,{"facility":345,"status":8,"city":346,"zip":347,"country":337,"contacts":348,"geoPoint":351},"Hadassah Medical Center ( Site 3001)","Jerusalem","9112001",[349],{"name":112,"role":113,"phone":350},"+97226777333",{"lat":352,"lon":353},31.76904,35.21633,{"facility":355,"status":8,"city":356,"zip":357,"country":337,"contacts":358,"geoPoint":361},"Rabin Medical Center ( Site 3002)","Petah Tikva","4941492",[359],{"name":112,"role":113,"phone":360},"+97239377377",{"lat":362,"lon":363},32.08707,34.88747,{"facility":365,"status":8,"city":366,"zip":367,"country":337,"contacts":368,"geoPoint":371},"Sheba Medical Center ( Site 3000)","Ramat Gan","5265601",[369],{"name":112,"role":113,"phone":370},"+97235303030",{"lat":372,"lon":373},32.08227,34.81065,{"facility":375,"status":8,"city":376,"state":377,"zip":378,"country":379,"contacts":380,"geoPoint":383},"Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 3021)","Milan","Milano","20133","Italy",[381],{"name":112,"role":113,"phone":382},"0223902557",{"lat":384,"lon":385},45.46427,9.18951,{"facility":387,"status":8,"city":388,"zip":389,"country":379,"contacts":390,"geoPoint":393},"Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3020)","Naples","80131",[391],{"name":112,"role":113,"phone":392},"+3908117770810",{"lat":394,"lon":395},40.85216,14.26811,{"facility":397,"status":8,"city":398,"zip":399,"country":379,"contacts":400,"geoPoint":403},"Istituto Oncologico Veneto IRCCS ( Site 3022)","Padova","35128",[401],{"name":112,"role":113,"phone":402},"0498215609",{"lat":404,"lon":405},44.38225,11.14261,{"facility":407,"status":8,"city":408,"zip":409,"country":379,"contacts":410,"geoPoint":413},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 3023)","Roma","00168",[411],{"name":112,"role":113,"phone":412},"+390630155202",{"lat":414,"lon":415},44.99364,11.10642,{"facility":417,"status":8,"city":418,"zip":419,"country":420,"contacts":421,"geoPoint":424},"Harbour Cancer & Wellness ( Site 3040)","Auckland","1023","New Zealand",[422],{"name":112,"role":113,"phone":423},"+6492203333",{"lat":425,"lon":426},-36.84853,174.76349,{"facility":428,"status":8,"city":429,"state":430,"zip":431,"country":432,"contacts":433,"geoPoint":436},"Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3061)","Poznan","Greater Poland Voivodeship","50 659","Poland",[434],{"name":112,"role":113,"phone":435},"+48611019893",{"lat":437,"lon":438},52.40692,16.92993,{"facility":440,"status":8,"city":441,"state":442,"zip":443,"country":432,"contacts":444,"geoPoint":447},"Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3060)","Warsaw","Masovian Voivodeship","02-781",[445],{"name":112,"role":113,"phone":446},"+48225462540",{"lat":448,"lon":449},52.22977,21.01178,{"facility":451,"status":8,"city":452,"state":453,"zip":454,"country":455,"contacts":456,"geoPoint":459},"Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4002)","Lisbon","Lisbon District","1449-005","Portugal",[457],{"name":112,"role":113,"phone":458},"+351210431000",{"lat":460,"lon":461},38.72509,-9.1498,{"facility":463,"status":8,"city":452,"zip":464,"country":455,"contacts":465,"geoPoint":468},"Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 4001)","1649-035",[466],{"name":112,"role":113,"phone":467},"+351210519790",{"lat":460,"lon":461},{"facility":470,"status":8,"city":471,"zip":472,"country":455,"contacts":473,"geoPoint":476},"Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 4000)","Porto","4200-072",[474],{"name":112,"role":113,"phone":475},"+351225084000",{"lat":477,"lon":478},41.1485,-8.61097,{"facility":480,"status":8,"city":481,"zip":482,"country":483,"contacts":484,"geoPoint":487},"Hospital Universitari Vall d'Hebron ( Site 3081)","Barcelona","08035","Spain",[485],{"name":112,"role":113,"phone":486},"+34932746000",{"lat":488,"lon":489},41.38879,2.15899,{"facility":491,"status":8,"city":481,"zip":492,"country":483,"contacts":493,"geoPoint":496},"Hospital Clínic Barcelona ( Site 3080)","08036",[494],{"name":112,"role":113,"phone":495},"+34932275402",{"lat":488,"lon":489},{"facility":498,"status":8,"city":499,"zip":500,"country":483,"contacts":501,"geoPoint":504},"Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 3082)","Madrid","28034",[502],{"name":112,"role":113,"phone":503},"+34913368263",{"lat":505,"lon":506},40.4165,-3.70256,[508],{"name":509,"role":113,"phone":510,"email":511},"Toll Free Number","1-888-577-8839","Trialsites@msd.com",[513],{"name":514,"affiliation":13,"role":515},"Medical Director","STUDY_DIRECTOR",[],[518,521],{"label":519,"url":520},"Merck Clinical Trials Information","https:\u002F\u002Fwww.merckclinicaltrials.com\u002F",{"label":522,"url":523},"Plain Language Summary","https:\u002F\u002Fwww.trialsummaries.com\u002FStudy\u002FStudyDetails?id=27190&tenant=MT_MSD_9011",{"nct_id":4,"conditions":525,"biomarkers":527},[526],"Cutaneous Melanoma",[],{"nct_id":4,"found":529,"summary":530,"prompt_version":540},true,{"design":531,"status":532,"heading":533,"summary":534,"follow_up":535,"word_count":536,"commitments":537,"compensation":538,"drugs_mentioned":539},"This interventional study plans to enroll 160 participants. It compares Intismeran autogene plus Pembrolizumab to a placebo plus Pembrolizumab.","completed","Clinical Study of Intismeran Autogene and Pembrolizumab for Melanoma","This study is testing if a combination of Intismeran autogene and Pembrolizumab (an immunotherapy that helps your immune system fight cancer) can stop advanced melanoma (a type of skin cancer that has spread and can't be surgically removed) from growing or spreading. Researchers want to see if people receiving Intismeran autogene with Pembrolizumab live longer without their cancer progressing compared to those receiving a placebo (an inactive substance) with Pembrolizumab. You could be eligible if you have unresectable Stage III or IV cutaneous melanoma and are at least 18 years old. The study aims to enroll 160 participants.","Participants will be followed for progression-free survival (how long they live without the cancer growing or spreading) for up to approximately 36 months.",98,"Not specified in the trial record.","Not stated in the trial record.",[34,42,51],"v2"]