[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659084":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":11,"studyPopulation":11,"armGroups":68,"interventions":80,"overallOfficials":91,"centralContacts":95,"locations":11,"responsibleParty":104,"collaborators":11,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":11,"enrollmentInfo":116,"targetDuration":11,"studyType":119,"phases":120,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":128,"whyStopped":11,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":11},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,15,18,21],{"measure":10,"description":11,"timeFrame":12},"Part 1: Serum Trough Concentration (Ctrough) After First Dose of Dostarlimab",null,"Up to 42 days",{"measure":14,"description":11,"timeFrame":12},"Part 1: Area Under the Concentration-time Curve (AUC) of Dostarlimab",{"measure":16,"description":11,"timeFrame":17},"Part 2: Observed Ctrough of Dostarlimab","Up to 168 days",{"measure":19,"description":11,"timeFrame":20},"Part 2: Model-predicted (MP) AUC of Dostarlimab","Up to 21 days",{"measure":22,"description":11,"timeFrame":17},"Part 2: MP AUC of Dostarlimab",[24,26,28,30,32,35,37,41,44,47,50,52,54,56,58,60],{"measure":25,"description":11,"timeFrame":12},"Part 1: Ctrough of Dostarlimab",{"measure":27,"description":11,"timeFrame":12},"Part 1: AUC of Dostarlimab",{"measure":29,"description":11,"timeFrame":12},"Part 1: Maximum Observed Concentration (Cmax) of Dostarlimab",{"measure":31,"description":11,"timeFrame":12},"Part 1: Time to Peak Drug Concentration (Tmax) of Dostarlimab",{"measure":33,"description":11,"timeFrame":34},"Parts 1 and 2: Number of Participants Experiencing Adverse Events (AEs), Serious AEs (SAEs), Treatment-emergent AEs (TEAEs) and Immune-mediated AEs (imAEs)","Up to 39 months",{"measure":36,"description":11,"timeFrame":34},"Parts 1 and 2: Number of Participants with TEAEs Leading to Infusion or Injection Interruption, Dose Modifications, Trial Intervention Discontinuation, or Death",{"measure":38,"description":39,"timeFrame":40},"Parts 1 and 2: Confirmed Overall Response Rate (ORR)","Confirmed ORR is defined as the percentage of participants reaching confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1 by blinded independent central review (BICR) and investigator assessment","Up to 3 years",{"measure":42,"description":43,"timeFrame":40},"Parts 1 and 2: Duration of Response (DoR)","DoR per RECIST 1.1 by BICR and investigator assessment is defined as the time from the date of first documented objective response of CR or PR that is subsequently confirmed until the date of first documented progressive disease (PD) or death due to any cause, whichever comes first",{"measure":45,"description":46,"timeFrame":40},"Parts 1 and 2: Progression-free Survival (PFS)","PFS is defined as the time from the date of randomization to the date of first documented objective tumor progression per RECIST 1.1 by BICR and investigator assessment or death due to any cause, whichever comes first",{"measure":48,"description":49,"timeFrame":40},"Parts 1 and 2: Overall Survival (OS)","OS is defined as the time from the date of randomization to the date of death due to any cause",{"measure":51,"description":11,"timeFrame":34},"Part 1: Number of Participants with Antidrug Antibody (ADAs) against Dostarlimab",{"measure":53,"description":11,"timeFrame":40},"Part 2: Number of Participants with ADAs against Dostarlimab",{"measure":55,"description":11,"timeFrame":17},"Part 2: MP Ctrough of Dostarlimab",{"measure":57,"description":11,"timeFrame":17},"Part 2: MP Ctrough at Steady State of Dostarlimab",{"measure":59,"description":11,"timeFrame":17},"Part 2: MP AUC at Steady State of Dostarlimab",{"measure":61,"description":11,"timeFrame":17},"Part 2: MP Cmax of Dostarlimab",{"allocation":63,"interventionModel":64,"interventionModelDescription":11,"primaryPurpose":65,"observationalModel":11,"timePerspective":11,"maskingInfo":66},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":67,"maskingDescription":11,"whoMasked":11},"NONE",[69,76],{"label":70,"type":71,"description":72,"interventionNames":73},"Part 1 (Phase 1b) SC dostarlimab and IV dostarlimab","EXPERIMENTAL","Participants will receive SC dostarlimab in Cohorts 1, 2, 4, 5 and 6, at different doses, to determine the doses of SC dostarlimab that will yield drug exposures comparable to approved IV dosing regimens. Participants in Cohort 3 will receive IV dostarlimab. Participants in all cohorts will receive carboplatin and paclitaxel. After 6 cycles, all participants will receive IV dostarlimab for up to 3 years until progression, death, or intolerable toxicities.",[74,75],"Biological: Dostarlimab","Drug: Carboplatin and paclitaxel",{"label":77,"type":71,"description":78,"interventionNames":79},"Part 2 (Phase 3): SC dostarlimab (experimental) or IV dostarlimab (standard of care)","Eligible participants will be randomly assigned to receive either SC dostarlimab or IV dostarlimab (standard of care arm) in a 1:1 ratio. Participants randomized to the experimental arm will receive SC dostarlimab in combination with carboplatin and paclitaxel for 6 cycles, followed by SC dostarlimab monotherapy for up to 3 years of treatment in total. Participants randomized to the standard of care arm will receive IV dostarlimab in combination with carboplatin and paclitaxel for 6 cycles, followed by IV dostarlimab monotherapy for up to 3 years of treatment in total.",[74,75],[81,86],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":11},"BIOLOGICAL","Dostarlimab","Dostarlimab will be administered as SC injection and IV infusion",[70,77],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":11},"DRUG","Carboplatin and paclitaxel","Carboplatin and paclitaxel will be administered as an IV infusion",[70,77],[92],{"name":93,"affiliation":5,"role":94},"GSK Clinical Trials","STUDY_DIRECTOR",[96,101],{"name":97,"role":98,"phone":99,"phoneExt":11,"email":100},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":102,"role":98,"phone":103,"phoneExt":11,"email":100},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":105,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659084","phase-1-two-part-phase1b-phase3-trial-of-subcutaneous-dostarlimab-plus-carboplatin-paclitaxel-in-participants-with-primary-advanced-or-recurrent-endometrial-cancer-100659084",false,"NCT07860450","Two Part (Phase1b\u002F Phase3) Trial of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer","An Open-label, Multicenter, 2-Part Study: A Phase 1b Dose Selection Followed by a Randomized Phase 3 to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel Versus Intravenous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer (SAPPHIRE)","SAPPHIRE","Inclusion Criteria:\n\n* Participant is at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of signing the Informed Consent Form (ICF).\n* Participant has primary Stage III or Stage IV disease or first recurrent EC.\n* Participant must have a documented Mismatch repair (MMR)\u002FMicrosatellite Instability (MSI) status.\n* Participant is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 for Part 1 and an ECOG performance status of 0 or 1 for Part 2.\n* Participant has adequate organ function.\n\nExclusion Criteria:\n\n* Participant has history of or active autoimmune disease that has required systemic treatments within the 2 years prior to screening.\n* Participant has a history of severe allergic and\u002For anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known hypersensitivity to carboplatin, paclitaxel or dostarlimab components or excipients.\n* Participant has received prior therapy with anti-programmed death protein 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-PD-L2 agent.\n* Participant has known uncontrolled brain or central nervous system (CNS) metastases.","FEMALE","18 Years",{"count":117,"type":118},380,"ESTIMATED","INTERVENTIONAL",[121,122],"PHASE1","PHASE2","This is an open-label study, meaning both the researchers and participants will know which treatment is being given.\n\nThe study has two parts. In Part 1, researchers will identify the most suitable SC dose. In Part 2, participants will be randomly assigned by chance to receive dostarlimab as either an SC injection or an IV infusion. All participants will also receive carboplatin and paclitaxel. Treatment may continue for up to 3 years, with participants closely monitored throughout the study.",[125],"Endometrial Carcinoma",[125,83,127],"Carboplatin-Paclitaxel","NOT_YET_RECRUITING","2026-09-30",{"date":131,"type":132},"2026-10-06","ACTUAL",{"date":134,"type":118},"2026-11-12",{"date":136,"type":118},"2032-11-05",{"name":5,"class":6}]