nctId: NCT06317311 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2026-07-15 date: 2027-08-31 date: 2024-03-19 date: 2024-03-19 name: GlaxoSmithKline class: INDUSTRY 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 conditions: Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Dostarlimab name: Carboplatin name: Paclitaxel measure: Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR) measure: DRR12 per RECIST 1.1, assessed by investigator measure: Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator measure: Overall survival (OS) measure: Overall response rate (ORR) per RECIST 1.1 assessed by BICR measure: ORR per RECIST 1.1 assessed by investigator measure: Disease control rate (DCR) per RECIST 1.1 assessed by BICR measure: DCR per RECIST 1.1 assessed by investigator measure: Duration of response (DOR) per RECIST 1.1 assessed by BICR measure: DOR per RECIST 1.1 assessed by investigator measure: Maximum concentration (Cmax) for dostarlimab measure: Minimum concentration (Cmin) for dostarlimab measure: Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity measure: Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation measure: Number of participants with AEs leading to death sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Aichi zip: 464-8681 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shiro Suzuki role: PRINCIPAL_INVESTIGATOR lat: 32.51879 lon: 130.62158 facility: GSK Investigational Site city: Chiba zip: 260-8717 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Naotake Tanaka role: PRINCIPAL_INVESTIGATOR lat: 35.6 lon: 140.11667 facility: GSK Investigational Site city: Ehime zip: 791-0280 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuhiro Takehara role: PRINCIPAL_INVESTIGATOR lat: 33.63163 lon: 132.76886 facility: GSK Investigational Site city: Fukuoka zip: 811-1395 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuya Ariyoshi role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Fukuoka zip: 830-0011 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shin Nishio role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Gunma zip: 373-8550 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuto Nakamura role: PRINCIPAL_INVESTIGATOR lat: 36.52592 lon: 138.97142 facility: GSK Investigational Site city: Hokkaido zip: 060-8648 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Hidemichi Watari role: PRINCIPAL_INVESTIGATOR lat: 43.41104 lon: 142.88878 facility: GSK Investigational Site city: Hyogo zip: 673-8558 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Satoshi Yamaguchi role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Ibaraki zip: 305-8576 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Toyomi Sato role: PRINCIPAL_INVESTIGATOR lat: 34.81641 lon: 135.56828 facility: GSK Investigational Site city: Iwate zip: 028-3695 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Tsukasa Baba role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Kanagawa zip: 259-1193 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Takeshi Hirasawa role: PRINCIPAL_INVESTIGATOR lat: 37.58333 lon: 139.91667 facility: GSK Investigational Site city: Okayama zip: 700-8558 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shoji Nagao role: PRINCIPAL_INVESTIGATOR lat: 34.65 lon: 133.93333 facility: GSK Investigational Site city: Osaka zip: 541-8567 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shoji Kamiura role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: GSK Investigational Site city: Osaka zip: 569-8686 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Satoe Fujiwara role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: GSK Investigational Site city: Saitama zip: 350-1298 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kosei Hasegawa role: PRINCIPAL_INVESTIGATOR lat: 35.90807 lon: 139.65657 facility: GSK Investigational Site city: Shizuoka zip: 411-8777 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yasuyuki Hirashima role: PRINCIPAL_INVESTIGATOR lat: 34.98333 lon: 138.38333 facility: GSK Investigational Site city: Tochigi zip: 329-0498 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yuji Takei role: PRINCIPAL_INVESTIGATOR lat: 36.38333 lon: 139.73333 facility: GSK Investigational Site city: Tokyo zip: 104-0045 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuki Sudo role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 135-8550 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mayu Yunokawa role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 160-8582 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Wataru Yamagami role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 hasResults: False