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Immunotherapy plus chemo shows promise for tough uterine cancer

NCT ID NCT07108270

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether the immunotherapy drug dostarlimab, given together with standard chemotherapy (carboplatin and paclitaxel), can help Chinese patients with a specific genetic type of advanced or recurrent endometrial cancer. The study will enroll 30 participants and measure how many have a lasting response for at least 12 months. The goal is to find a more effective treatment for this hard-to-treat cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dostarlimab (an immunotherapy drug) combined with chemotherapy drugs carboplatin and paclitaxel
What this could lead to
If successful, this could offer a new treatment option for Chinese patients with a specific type of advanced or recurrent endometrial cancer.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The combination therapy may cause side effects like immune reactions or typical chemo toxicities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant has histologically or cytologically proven EC with recurrent or advanced disease. 2. Participant has molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention. 3. 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: 1. Has primary Stage III to IV disease and is naive to systemic anticancer therapy for EC; 2. Has first recurrent disease and is naïve to systemic anticancer therapy for EC; 3. Had received prior neo-adjuvant/adjuvant anticancer therapy and had a recurrence or PD ≥6 months after completing treatment (first recurrence only). 4. 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. 5. 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). 6. Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1. 7. Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters. Exclusion Criteria: 1. 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. 2. Participant has any medical history of interstitial lung disease or pneumonitis. 3. Participant has cirrhosis or current unstable liver or biliary disease. 4. Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. 5. Participant has a diagnosis of immunodeficiency. 6. 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. 7. Participant has not recovered adequately from AEs. 8. 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. 9. 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. 10. 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. 11. Participant is known human immunodeficiency virus (HIV) infection. 12. 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. 13. Participant with contraindication to carboplatin and paclitaxel.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Jinan, Shandong, 250117, China

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