NCT06317311Active, not recruitingPhase 2
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 12 Mar 2024
- Start date
- 7 May 2024
- Primary completion date
- 14 Dec 2026
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Endometrial cancer
- NCT number
- NCT06317311
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 41
- From 7 May 2024 to the primary completion date, 14 Dec 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to the first dose of study intervention, whichever is shorter.
- Participant has received any live vaccine within 30 days of the first dose of study intervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms are not exclusionary.
- Participant is currently participating and receiving study intervention or has participated in a study of an investigational agent and received study intervention or used an investigational device within 4 weeks of the first dose of treatment.
Other illness
- Participant has any medical history of interstitial lung disease or pneumonitis.
- Participant has cirrhosis or current unstable liver or biliary disease.
- Participant has HBsAg positive, or HCV RNA positive.
- Participant is known HIV infection.
Lab values
- Participant has received prior therapy with an anti- Programmed death protein 1 (PD-1), anti- Programmed death ligand 1 (PD-L1), anti- Programmed death ligand 2 (PD-L2), or anti- Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.
Other
- Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant has a diagnosis of immunodeficiency.
- Participant has not recovered adequately from AEs.
- Participant with contraindication to carboplatin and paclitaxel.
Who the study is looking for
- Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
- Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
- Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator's assessment.
- Participant is not pregnant or breastfeeding and agrees to use a highly effective contraceptive method during the study period if a woman of childbearing potential (WOCBP).
- Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1.
- Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Gunma | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Numakunai | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.