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Neoplasms, EndometrialPhase 2NCT07108270

A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)

A Phase 2 study testing Dostarlimab, Carboplatin and Paclitaxel in people with Neoplasms, Endometrial, run by GlaxoSmithKline at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to see how well dostarlimab works when administered with the chemotherapy drugs carboplatin and paclitaxelin in treating EC in Chinese participants. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Endometrial
What is being tested?
Dostarlimab, Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
27 Nov 2025to 31 Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has histologically or cytologically proven EC with recurrent or advanced disease.
  • Participant has molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention.
  • Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one target lesion per RECIST 1.1 based on Investigator's assessment and meet at least 1 of the following criteria:
  • Has primary Stage III to IV disease and is naive to systemic anticancer therapy for EC;
  • Has first recurrent disease and is naïve to systemic anticancer therapy for EC;
  • Had received prior neo-adjuvant/adjuvant anticancer therapy and had a recurrence or PD ≥6 months after completing treatment (first recurrence only).
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  • Participant has adequate archive tumor tissue sample for MMR/MSI status testing. If no archival tissue is available, tissue sample must be obtained before study intervention.
  • 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.

Who cannot join

  • 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 any medical history of interstitial lung disease or pneumonitis.
  • Participant has cirrhosis or current unstable liver or biliary disease.
  • Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
  • Participant has a diagnosis of immunodeficiency.
  • 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.
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  • Participant has not recovered adequately from AEs.
  • Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days prior to the first dose of study intervention.
  • 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 has Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C virus (HCV) Ribonucleic acid (RNA) positive at screening or within 3 months prior to the first dose of study intervention.
  • Participant is known human immunodeficiency virus (HIV) infection.
  • 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.
  • Participant with contraindication to carboplatin and paclitaxel.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

China1 site, 1 recruiting

  • GSK Investigational Site

    Jinan, Shandong, 250117

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Participants With dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer in China (China RUBY)

The goal of this clinical trial is to see how well dostarlimab works when administered with the chemotherapy drugs carboplatin and paclitaxelin in treating EC in Chinese participants. The study aims to understand the treatments effectiveness, safety, how the drugs behave in the body, and whether it causes any immune reactions.

Being tested
Dostarlimab, Carboplatin, Paclitaxel
Keywords
Endometrial cancer, Dostarlimab, Carboplatin, Paclitaxel
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DostarlimabBiological

    Dostarlimab will be administered.

  • CarboplatinDrug

    Carboplatin will be administered.

  • PaclitaxelDrug

    Paclitaxel will be administered.

Study groups in NCT07108270
Study groupRoleWhat they receive
Dostarlimab-Carboplatin-Paclitaxel followed by Dostarlimab MonotherapyExperimentalNot described
Receives: Biological: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Durable Response Rate for 12 months (DRR12) assessed by Blinded Independent Central Review (BICR)

    DRR12 is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR), and Duration of Response (DOR) lasting greater than or equal to (≥) 12 months, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).

    Measured: Up to approximately 148 weeks

Secondary outcomes (15)

  1. DRR12 assessed by Investigator

    DRR12 is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR), and Duration of Response (DOR) lasting greater than or equal to (≥) 12 months, per RECIST 1.1.

    Measured: Up to approximately 148 weeks

  2. Progression-free survival (PFS) per RECIST 1.1, assessed by BICR

    PFS is defined as the time from the date of first dose to the date of first documented disease progression (PD) or death due to any cause, whichever comes first.

    Measured: Up to 226 weeks

  3. Progression-free survival (PFS) per RECIST 1.1, assessed by investigator

    PFS is defined as the time from the date of first dose to the date of first documented PD or death due to any cause, whichever comes first.

    Measured: Up to 226 weeks

  4. Overall survival (OS)

    OS is defined as time from first dose of study intervention to death from any cause.

    Measured: Up to 226 weeks

  5. Overall response rate (ORR) per RECIST 1.1 assessed by BICR

    ORR is defined as the proportion of participants with confirmed CR or PR.

    Measured: Up to 226 weeks

  6. ORR per RECIST 1.1 assessed by Investigator

    ORR is defined as the proportion of participants with confirmed CR or PR.

    Measured: Up to 226 weeks

  7. Duration of response (DOR) per RECIST 1.1 assessed by BICR

    DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented PD or death due to any cause, whichever comes first.

    Measured: Up to 226 weeks

  8. DOR per RECIST 1.1 assessed by Investigator

    DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented PD or death due to any cause, whichever comes first.

    Measured: Up to 226 weeks

  9. Serum concentration of dostarlimab

    Measured: Up to 67 weeks

  10. Concentration at the end of infusion (C-EOI) for dostarlimab

    Measured: Up to 67 weeks

  11. Trough concentration (Ctrough) for dostarlimab

    Measured: Up to 67 weeks

  12. Number of participants with Anti-drug antibody (ADA) against dostarlimab

    Measured: Up to 226 weeks

  13. Number of participants with adverse events (AEs), Immune-mediated adverse events (imAEs), and serious adverse events (SAEs) by severity

    Measured: Up to 226 weeks

  14. Number of participants with AEs, imAEs, and SAEs leading to dose modifications or study intervention discontinuation

    Measured: Up to 226 weeks

  15. Number of participants with AEs leading to death

    Measured: Up to 226 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start27 Nov 2025
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108270
Sponsor's protocol ID
222258
Status last verified
Dec 2025
First submitted
5 Aug 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab, Carboplatin and Paclitaxel in people with Neoplasms, Endometrial, run by GlaxoSmithKline at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durable Response Rate for 12 months (DRR12) assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 148 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07108270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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