protocolSection identificationModule nctId: NCT06317311, orgStudyIdInfo id: 221968, briefTitle: A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer, acronym: RUBY-J, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2026-07-15, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer, conditionsModule conditions: Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Dostarlimab, interventions name: Carboplatin, interventions name: Paclitaxel, outcomesModule primaryOutcomes measure: Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR), secondaryOutcomes measure: DRR12 per RECIST 1.1, assessed by investigator, secondaryOutcomes measure: Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall response rate (ORR) per RECIST 1.1 assessed by BICR, secondaryOutcomes measure: ORR per RECIST 1.1 assessed by investigator, secondaryOutcomes measure: Disease control rate (DCR) per RECIST 1.1 assessed by BICR, secondaryOutcomes measure: DCR per RECIST 1.1 assessed by investigator, secondaryOutcomes measure: Duration of response (DOR) per RECIST 1.1 assessed by BICR, secondaryOutcomes measure: DOR per RECIST 1.1 assessed by investigator, secondaryOutcomes measure: Maximum concentration (Cmax) for dostarlimab, secondaryOutcomes measure: Minimum concentration (Cmin) for dostarlimab, secondaryOutcomes measure: Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity, secondaryOutcomes measure: Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation, secondaryOutcomes measure: Number of participants with AEs leading to death, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Aichi, zip: 464-8681, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Shiro Suzuki, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.51879, lon: 130.62158, locations facility: GSK Investigational Site, city: Chiba, zip: 260-8717, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Naotake Tanaka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6, lon: 140.11667, locations facility: GSK Investigational Site, city: Ehime, zip: 791-0280, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kazuhiro Takehara, role: 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city: Gunma, zip: 373-8550, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kazuto Nakamura, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.52592, lon: 138.97142, locations facility: GSK Investigational Site, city: Hokkaido, zip: 060-8648, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Hidemichi Watari, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.41104, lon: 142.88878, locations facility: GSK Investigational Site, city: Hyogo, zip: 673-8558, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Satoshi Yamaguchi, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Ibaraki, zip: 305-8576, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Toyomi Sato, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.81641, lon: 135.56828, locations facility: GSK Investigational Site, city: Iwate, zip: 028-3695, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Tsukasa Baba, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Kanagawa, zip: 259-1193, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Takeshi Hirasawa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.58333, lon: 139.91667, locations facility: GSK Investigational Site, city: Okayama, zip: 700-8558, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Shoji Nagao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.65, lon: 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8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mayu Yunokawa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Tokyo, zip: 160-8582, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Wataru Yamagami, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False