[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659929":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":41,"interventions":59,"overallOfficials":99,"centralContacts":34,"locations":34,"responsibleParty":103,"collaborators":34,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":34,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":34,"enrollmentInfo":114,"targetDuration":34,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":34,"overallStatus":124,"whyStopped":34,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":34},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":34},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Number of Participants Who Experience a Dose-limiting Toxicity (DLT) as Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 6.0","A DLT is defined as any drug-related AE observed during the DLT evaluation period that meet criteria specified in the protocol. DLTs will be evaluated until 21 days after the first fixed dose during fixed-dose escalation and until 21 days after the first target dose during step-up dose escalation and dose interval extension.","Up to 21 days at each dose level",{"measure":14,"description":15,"timeFrame":16},"Number of participants who experience one or more 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. The number of participants that experience AEs will be reported.","Up to approximately 56 months",{"measure":18,"description":19,"timeFrame":16},"Number of participants who discontinue study intervention due to an 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. The number of participants that discontinue study intervention due to an AE will be reported.",[21,25,28,31],{"measure":22,"description":23,"timeFrame":24},"Area Under the Serum Concentration-Time Curve (AUC) of MK-6255","AUC is defined as the measure of overall drug exposure over time after administration. Blood samples will be collected to determine the AUC of MK-6255.","At designated timepoints (up to approximately 2 weeks postdose)",{"measure":26,"description":27,"timeFrame":24},"Minimum Serum Concentration (Cmin) of MK-6255","Cmin is defined as the lowest observed concentration of a drug after administration. Blood samples will be collected to determine the Cmin of MK-6255.",{"measure":29,"description":30,"timeFrame":24},"Maximum Serum Concentration (Cmax) of MK-6255","Cmax is defined as the highest observed concentration of a drug after administration. Blood samples will be collected to determine the Cmax of MK-6255.",{"measure":32,"description":33,"timeFrame":24},"Time to Maximum Serum Concentration (Tmax) of MK-6255","Tmax is defined as the time at which the maximum observed concentration of a drug occurs after administration. Blood samples will be collected to determine the Tmax of MK-6255.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE",[42,55],{"label":43,"type":44,"description":45,"interventionNames":46},"Dose Escalation","EXPERIMENTAL","Participants receive MK-6255 once every week (QW).",[47,48,49,50,51,52,53,54],"Biological: MK-6255","Other: CD8 PET Tracer","Drug: Acetaminophen","Drug: Diphenhydramine","Drug: Dexamethasone","Biological: Tocilizumab","Biological: Tocilizumab biosimilar","Biological: Siltuximab",{"label":56,"type":44,"description":57,"interventionNames":58},"Dose Interval Extension","Participants receive MK-6255 at extended interval dosing.",[47,48,49,50,51,52,53,54],[60,65,73,78,82,86,90,96],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":34},"BIOLOGICAL","MK-6255","During initial dose escalation, participants will receive MK-6255 one weekly (QW). During Dose Interval Extension, participants will receive target doses every 3 weeks (Q3W).",[43,56],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"OTHER","CD8 PET Tracer","Participants may receive an optional CD8 PET tracer for exploratory imaging assessments.",[43,56],[71,72],"GEH200520","GEH200521 (18F)",{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":34},"DRUG","Acetaminophen","Participants will receive acetaminophen (or similar antipyretic) as premedication.",[43,56],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":34},"Diphenhydramine","Participants will receive diphenhydramine (or similar antihistamine) as premedication.",[43,56],{"type":74,"name":83,"description":84,"armGroupLabels":85,"otherNames":34},"Dexamethasone","Participants will receive dexamethasone as premedication.",[43,56],{"type":61,"name":87,"description":88,"armGroupLabels":89,"otherNames":34},"Tocilizumab","Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.",[43,56],{"type":61,"name":91,"description":88,"armGroupLabels":92,"otherNames":93},"Tocilizumab biosimilar",[43,56],[94,95],"Avtozma®","Tyenne®",{"type":61,"name":97,"description":88,"armGroupLabels":98,"otherNames":34},"Siltuximab",[43,56],[100],{"name":101,"affiliation":5,"role":102},"Medical Director","STUDY_DIRECTOR",{"type":104,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100659929","phase-1-a-clinical-trial-of-mk-6255-to-treat-endometrial-and-ovarian-cancer-mk-6255-001-100659929",false,"NCT07870278","A Clinical Trial of MK-6255 to Treat Endometrial and Ovarian Cancer (MK-6255-001)","A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-6255 Monotherapy in Advanced Solid Tumors","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has one of the following diagnoses:\n\n  * Recurrent, pathologically documented epithelial OC, primary peritoneal cancer, or fallopian tube cancer that is either (1) platinum resistant or (2) platinum sensitive, with progression during prior treatment with poly-adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi)\n  * Histologically confirmed well, moderately, or poorly differentiated (ie, Grade 1 to Grade 3) serous or endometrioid EC that has progressed after at least 1 line of platinum-based therapy in any setting\n* Has received all protocol-required and available standard of care (SOC) therapies, unless ineligible for or intolerant to the therapies\n* Has provided archival tumor tissue or a recently obtained biopsy before treatment start\n* If living with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy (ART)\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral - therapy for at least 4 weeks\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has adequate organ function\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of any 1 of the following: Primary platinum-refractory OC; neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas; carcinosarcoma; EC that is amenable to curative-intent surgery or curative-intent radiotherapy; or EC that requires recurrent drainage of effusions\n* Has a history of serious cardiovascular and cerebrovascular diseases\n* Has a history or presence of clinically relevant central nervous system (CNS) diseases\n* Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before start of study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Is living with HIV and has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications","FEMALE","18 Years",{"count":115,"type":116},80,"ESTIMATED","INTERVENTIONAL",[119],"PHASE1","Researchers are looking for new ways to treat advanced and recurrent endometrial cancer (EC) and ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Recurrent means the cancer came back after treatment.\n\nMK-6255 is a trial medicine designed to treat advanced and recurrent EC and OC. This trial is the first time that researchers will give MK-6255 to people.\n\nThe goals of this trial are to learn about:\n\n* The safety of MK-6255 and if participants tolerate it. Tolerate means participants will receive the trial medicine unless they need to stop it due to health problems.\n* What happens to different dose levels (amounts) of MK-6255 in the body over time.",[122,123],"Ovarian Neoplasms","Endometrial Neoplasms","NOT_YET_RECRUITING","2026-10-06",{"date":127,"type":128},"2026-10-13","ACTUAL",{"date":130,"type":116},"2026-11-13",{"date":132,"type":116},"2031-07-07",{"name":5,"class":6}]