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CarcinomaPhase 2RUBY-JNCT06317311

A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer

A Phase 2 study testing Dostarlimab, Carboplatin and Paclitaxel in people with Carcinoma, run by GlaxoSmithKline at 15 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Carcinoma
What is being tested?
Dostarlimab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
15 sitesJapan
Study dates
7 May 2024to 30 Sep 2028
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 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.

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 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 has HBsAg positive, or HCV RNA positive.
  • Participant is known 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

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • GSK Investigational Site

    Aichi, 464-8681

  • GSK Investigational Site

    Fukuoka, 811-1395

  • GSK Investigational Site

    Fukuoka, 830-0011

  • GSK Investigational Site

    Gunma, 373-8550

  • GSK Investigational Site

    Hokkaido, 060-8648

  • GSK Investigational Site

    Hyōgo, 673-8558

  • GSK Investigational Site

    Numakunai, 028-3695

  • GSK Investigational Site

    Okayama, 700-8558

  • GSK Investigational Site

    Osaka, 541-8567

  • GSK Investigational Site

    Osaka, 569-8686

  • GSK Investigational Site

    Saitama, 350-1298

  • GSK Investigational Site

    Shizuoka, 411-8777

  • GSK Investigational Site

    Tokyo, 104-0045

  • GSK Investigational Site

    Tokyo, 135-8550

  • GSK Investigational Site

    Tokyo, 160-8582

Other trials in Japan

About this study

Official title: 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)

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

What participants receive

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

  • DostarlimabBiological

    Dostarlimab is administered via intravenous (IV) infusion at a dose of 500 milligram (mg) for first 6 cycles (each cycle is of 21 days) followed by 1,000 mg from cycle 7 (each cycle is of 42 days)

  • CarboplatinDrug

    Carboplatin is administered IV at a dose of Area under the concentration time curve (AUC) 5 milligram*millilitre/ minute (mg•mL/min) for cycles 1 to 6 (each cycle is of 21 days)

  • PaclitaxelDrug

    Paclitaxel is administered IV at a dose of 175 milligram per meter square (mg/m2) for cycles 1 to 6 (each cycle is of 21 days)

Study groups in NCT06317311
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 Complete Response (CR) or Partial Response (PR) lasting greater than or equal to (≥) 12 months, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

    Measured: Approximately 18 months

Secondary outcomes (14)

  1. DRR12 per RECIST 1.1, assessed by investigator

    Measured: Approximately 18 months

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

    PFS is defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause

    Measured: Up to approximately 3 years

  3. Overall survival (OS)

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

    Measured: Up to approximately 3 years

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

    ORR is achieving a best overall response (BOR) of CR or PR. BOR is defined as the best confirmed response [CR > PR > Stable disease (SD) > Progressive Disease (PD) > Not evaluable (NE)] from treatment start date until disease progression, death or initiation of next line of therapy, whichever is earlier

    Measured: Up to approximately 3 years

  5. ORR per RECIST 1.1 assessed by investigator

    Measured: Up to approximately 3 years

  6. Disease control rate (DCR) per RECIST 1.1 assessed by BICR

    Achieving a BOR of CR, PR, or SD, defined as the best confirmed response (CR > PR > SD) from treatment start date until disease progression, death or initiation of next line of therapy, whichever is earlier

    Measured: Up to approximately 3 years

  7. DCR per RECIST 1.1 assessed by investigator

    Measured: Up to approximately 3 years

  8. 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 to the date of first documented PD or death, whichever comes first

    Measured: Up to approximately 3 years

  9. DOR per RECIST 1.1 assessed by investigator

    Measured: Up to approximately 3 years

  10. Maximum concentration (Cmax) for dostarlimab

    Measured: Up to 67 weeks

  11. Minimum concentration (Cmin) for dostarlimab

    Measured: Up to 67 weeks

  12. Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity

    Measured: Up to approximately 3 years

  13. Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation

    Measured: Up to approximately 3 years

  14. Number of participants with AEs leading to death

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted19 Mar 2024
  2. Study start7 May 2024
  3. Primary completion14 Dec 2026 (estimated)
  4. Study completion30 Sep 2028 (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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06317311
Sponsor's protocol ID
221968
Acronym
RUBY-J
Status last verified
Oct 2026
First submitted
12 Mar 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab, Carboplatin and Paclitaxel in people with Carcinoma, run by GlaxoSmithKline at 15 sites in Japan.

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 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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: Approximately 18 months). 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 NCT06317311.

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 2 Nov 2026.

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