[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654016":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":51,"interventions":95,"overallOfficials":150,"centralContacts":154,"locations":160,"responsibleParty":244,"collaborators":43,"id":246,"slug":247,"hasResults":248,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":43,"eligibilityCriteria":252,"healthyVolunteers":248,"sex":253,"minAge":254,"maxAge":43,"enrollmentInfo":255,"targetDuration":43,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":43,"overallStatus":265,"whyStopped":43,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":43},[9,13,15,19],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Adverse Events (AEs)","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.","Up to approximately 24 months",{"measure":14,"description":11,"timeFrame":12},"Number of Participants Who Discontinue Study Treatment Due to an AE",{"measure":16,"description":17,"timeFrame":18},"Number of Participants Who Experience Dose-Limiting Toxicity (DLT)","DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.","Up to approximately 28 days",{"measure":20,"description":21,"timeFrame":12},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.",[23,27,31,34,37,40],{"measure":24,"description":25,"timeFrame":26},"Duration of Response (DOR)","For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.","Up to approximately 48 months",{"measure":28,"description":29,"timeFrame":30},"Area Under the Curve From Time 0 to Last (AUC0-last) of MK-2010","Blood samples will be collected to determine the AUC0-last of MK-2010.","Predose and at designated time points up to approximately 24 months",{"measure":32,"description":33,"timeFrame":30},"Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of MK-2010","Blood samples will be collected to determine the AUC0-tau of MK-2010.",{"measure":35,"description":36,"timeFrame":30},"Trough Concentration (Ctrough) of MK-2010","Blood samples will be collected to determine Ctrough of MK-2010.",{"measure":38,"description":39,"timeFrame":30},"Maximum Concentration (Cmax) of MK-2010","Blood samples will be collected to determine Cmax of MK-2010.",{"measure":41,"description":42,"timeFrame":30},"Incidence of Antidrug Antibodies (ADAs) to MK-2010","Blood samples will be collected to determine ADAs of MK-2010.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"NON_RANDOMIZED","PARALLEL","For the MK-2010 + FOLFOX and Pembrolizumab + FOLFOX treatment arms, participants will be randomized in a 1:1 ratio to either MK-2010 + FOLFOX or Pembrolizumab + FOLFOX. For all other treatment arms, participants will be allocated to their respective treatment arm.","TREATMENT",{"masking":50,"maskingDescription":43,"whoMasked":43},"NONE",[52,62,68,72,77,83,90],{"label":53,"type":54,"description":55,"interventionNames":56},"MK-2010 + FOLFOX","EXPERIMENTAL","Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).",[57,58,59,60,61],"Biological: MK-2010","Drug: 5-Fluorouracil","Drug: Leucovorin or Levoleucovorin","Drug: Oxaliplatin","Drug: Epinephrine",{"label":63,"type":64,"description":65,"interventionNames":66},"Pembrolizumab + FOLFOX","ACTIVE_COMPARATOR","Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).",[67,58,59,60,61],"Biological: Pembrolizumab",{"label":69,"type":54,"description":70,"interventionNames":71},"MK-2010 Monotherapy","Participants receive MK-2010 intravenously as monotherapy.",[57,61],{"label":73,"type":54,"description":74,"interventionNames":75},"MK-2010 + Belzutifan","Participants receive MK-2010 intravenously in combination with oral Belzutifan.",[57,76,61],"Drug: Belzutifan",{"label":78,"type":54,"description":79,"interventionNames":80},"MK-2010 + Gemcitabine\u002FCisplatin","Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy.",[57,81,82,61],"Drug: Gemcitabine","Drug: Cisplatin",{"label":84,"type":54,"description":85,"interventionNames":86},"MK-2010 + Carboplatin and Paclitaxel\u002FNab-paclitaxel","Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy.",[57,87,88,89,61],"Drug: Carboplatin","Drug: Paclitaxel","Drug: Nab-paclitaxel",{"label":91,"type":54,"description":92,"interventionNames":93},"MK-2010 + Pemetrexed and Cisplatin\u002FCarboplatin","Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy.",[57,82,87,94,61],"Drug: Pemetrexed",[96,103,109,116,119,122,128,131,134,137,140,143,146],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"BIOLOGICAL","MK-2010","Administered as an intravenous (IV) infusion.",[73,84,53,78,91,69],[102],"LM-299",{"type":97,"name":104,"description":105,"armGroupLabels":106,"otherNames":107},"Pembrolizumab","Administered intravenously as 400 mg every 6 weeks.",[63],[108],"MK-3475, Keytruda",{"type":110,"name":111,"description":112,"armGroupLabels":113,"otherNames":114},"DRUG","5-Fluorouracil","Administered intravenously per approved product label.",[53,63],[115],"5-FU, Fluorouracil",{"type":110,"name":117,"description":112,"armGroupLabels":118,"otherNames":43},"Leucovorin or Levoleucovorin",[53,63],{"type":110,"name":120,"description":112,"armGroupLabels":121,"otherNames":43},"Oxaliplatin",[53,63],{"type":110,"name":123,"description":124,"armGroupLabels":125,"otherNames":126},"Belzutifan","Administered orally as 120 mg daily.",[73],[127],"MK-6482, PT2977",{"type":110,"name":129,"description":112,"armGroupLabels":130,"otherNames":43},"Gemcitabine",[78],{"type":110,"name":132,"description":112,"armGroupLabels":133,"otherNames":43},"Cisplatin",[78,91],{"type":110,"name":135,"description":112,"armGroupLabels":136,"otherNames":43},"Carboplatin",[84,91],{"type":110,"name":138,"description":112,"armGroupLabels":139,"otherNames":43},"Paclitaxel",[84],{"type":110,"name":141,"description":112,"armGroupLabels":142,"otherNames":43},"Nab-paclitaxel",[84],{"type":110,"name":144,"description":112,"armGroupLabels":145,"otherNames":43},"Pemetrexed",[91],{"type":110,"name":147,"description":148,"armGroupLabels":149,"otherNames":43},"Epinephrine","Administered per approved product label as rescue medication.",[73,84,53,78,91,69,63],[151],{"name":152,"affiliation":5,"role":153},"Medical Director","STUDY_DIRECTOR",[155],{"name":156,"role":157,"phone":158,"phoneExt":43,"email":159},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[161,178,190,203,216,231],{"facility":162,"status":43,"city":163,"state":164,"zip":165,"country":166,"countryCode":167,"cosmosGeoPoint":168,"geoPoint":173,"contacts":174},"New Jersey Cancer Care ( Site 7002)","Belleville","New Jersey","07109","United States","US",{"type":169,"coordinates":170},"Point",[171,172],-74.15014,40.79371,{"lat":172,"lon":171},[175],{"name":176,"role":157,"phone":177,"phoneExt":43,"email":43},"Study Coordinator","973-751-8880",{"facility":179,"status":43,"city":180,"state":164,"zip":181,"country":166,"countryCode":167,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"START Astera, LLC ( Site 0220)","East Brunswick","08816",{"type":169,"coordinates":183},[184,185],-74.41598,40.42788,{"lat":185,"lon":184},[188],{"name":176,"role":157,"phone":189,"phoneExt":43,"email":43},"732-426-4750",{"facility":191,"status":43,"city":192,"state":193,"zip":194,"country":166,"countryCode":167,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Taylor Cancer Research Center ( Site 9500)","Maumee","Ohio","43537",{"type":169,"coordinates":196},[197,198],-83.65382,41.56283,{"lat":198,"lon":197},[201],{"name":176,"role":157,"phone":202,"phoneExt":43,"email":43},"567-402-4502",{"facility":204,"status":43,"city":205,"state":206,"zip":207,"country":166,"countryCode":167,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001)","Eugene","Oregon","97401",{"type":169,"coordinates":209},[210,211],-123.08675,44.05207,{"lat":211,"lon":210},[214],{"name":176,"role":157,"phone":215,"phoneExt":43,"email":43},"541-683-5001",{"facility":217,"status":43,"city":218,"state":219,"zip":220,"country":221,"countryCode":222,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Cantonal Hospital St.Gallen ( Site 1100)","Sankt Gallen","Canton of St. Gallen","9007","Switzerland","CH",{"type":169,"coordinates":224},[225,226],9.37477,47.42391,{"lat":226,"lon":225},[229],{"name":176,"role":157,"phone":230,"phoneExt":43,"email":43},"+41714941111",{"facility":232,"status":43,"city":233,"state":234,"zip":235,"country":221,"countryCode":222,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"CHUV (centre hospitalier universitaire vaudois) ( Site 1101)","Lausanne","Canton of Vaud","1011",{"type":169,"coordinates":237},[238,239],6.63282,46.516,{"lat":239,"lon":238},[242],{"name":176,"role":157,"phone":243,"phoneExt":43,"email":43},"+41213140155",{"type":245,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100654016","phase-2-a-clinical-trial-of-mk-2010-alone-and-with-other-treatments-in-participants-with-advanced-solid-tumors-mk-2010-002-100654016",false,"NCT07793942","A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)","A Phase 2, Open-label Clinical Study to Evaluate the Safety and Efficacy of MK-2010 as Monotherapy and in Combination","Inclusion Criteria:\n\n* Has radiographically measurable disease per protocol\n* If to receive oral study treatment, has the ability to swallow and retain oral medication and does not have gastrointestinal abnormalities that may alter absorption\n* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if diagnosed with HIV\n* Has adequate organ function per protocol\n\nExclusion Criteria:\n\n* Has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease if diagnosed with HIV\n* Has a history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder\n* Has hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis\n* Has a history of confirmed inflammatory bowel disease\n* Has a serious active nonhealing wound, ulcer, and\u002For bone fracture\n* Has a history of myocarditis or cardiomyopathy\n* Has a history of or current severe cardiovascular and cerebrovascular diseases\n* Is currently receiving any anticoagulants\n* Has a diagnosis of immunodeficiency\n* Has a known additional malignancy that is progressing or required active treatment within the past 3 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that required systemic treatment in the past 2 years (hormonal supplementation \\[eg, thyroxine, insulin, or physiologic corticosteroid\\] is allowed)\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or from central venous access device placement, or has ongoing surgical complications","ALL","18 Years",{"count":256,"type":257},480,"ESTIMATED","INTERVENTIONAL",[260],"PHASE2","Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced means the cancer has spread nearby or to other parts in the body and cannot be removed with surgery.\n\nIn this trial, researchers want to learn if the trial medicine called MK-2010, given alone or with other treatments, can treat advanced solid tumors. MK-2010 is designed to help the immune system fight cancer.\n\nThe goals of this trial are to learn:\n\n* About the safety of MK-2010 as monotherapy and in combinations and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.\n* How many participants who receive MK-2010 as monotherapy and in combination respond to treatment. Respond means the cancer gets smaller or goes away.",[263,264],"Malignant Neoplam","Advanced Solid Tumors","NOT_YET_RECRUITING","2026-10-06",{"date":268,"type":269},"2026-10-08","ACTUAL",{"date":271,"type":257},"2026-10-27",{"date":273,"type":257},"2030-07-28",{"name":5,"class":6},6]