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New drug combo aims to tame advanced uterine cancer

NCT ID NCT07652515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the safety of the immunotherapy drug dostarlimab when given together with standard chemotherapy (carboplatin and paclitaxel) as a first treatment for adults in India with advanced or recurrent endometrial cancer. Participants receive the drug combination initially, followed by dostarlimab alone. The main goal is to track serious side effects over about a year.

What this could mean

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

Active substance
dostarlimab (with carboplatin and paclitaxel)
What this could lead to
If successful, this could confirm a safer treatment option for advanced or recurrent endometrial cancer, potentially improving outcomes for patients in India.
What could go wrong
This is a single-arm, open-label study with no comparison group, so results may not prove effectiveness. Side effects from the drug combination, including immune-related reactions, are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 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: * Participant with greater than or equals to (\>=) 18 years of age, at the time of signing the informed consent. * Participant has histologically or cytologically proven EC with recurrent or advanced disease. * 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 based on investigator's assessment. * Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement. * Woman of childbearing potential (WOCBP) agrees to use contraceptive from screening through at least 180 days after the last dose. * Negative urine pregnancy test at most 24 hours prior to the first dose of study intervention. * Capable of giving signed informed consent. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Participant has had greater than (\>) 1 recurrence of endometrial cancer. * Participant has a concomitant malignancy, or participant has a prior non endometrial invasive malignancy who has been disease-free for less than (\<) 3 years or who received any active treatment in the last 3 years for that malignancy. * Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. * Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy. * Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. * Participant has not recovered (i.e., to Grade less than or equal to \[\<=\] 1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor \[G-CSF\], Granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 21 days prior to the first dose of study drug. * Either the history of hypersensitivity to excipients of the study intervention or to drugs with a similar chemical structure or class of the study intervention. * Participant has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \[qualitative\] is detected). * Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and: * has not had a recurrence or Progressive disease (PD) prior to first dose on the study, or * has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study. * Participant has received prior therapy with an anti- Programmed death protein 1 (anti-PD-1), anti- Programmed death ligand 1 (anti-PD-L1), or Programmed death ligand 2 (anti PD L2) agent. * Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days or \<5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter. * Systemic glucocorticoids for any purpose other than to manage symptoms of suspected irAEs. If medically deemed necessary (e.g., acute asthma or chronic obstructive pulmonary disease exacerbation, prophylaxis for intravenous (IV) contrast if indicated), Investigators are allowed to use their judgment to treat participants with systemic steroids. In such cases, systemic steroids should be stopped at least 24 hours prior to the next dose of study treatment. * Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study intervention, during study treatment, and for up to 180 days after receiving the last dose of study intervention. * Participant has a diagnosis of immunodeficiency and is receiving systemic steroid therapy (\>10 milligrams \[mg\] daily prednisone or equivalent) within 7 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. * Participant is currently receiving study intervention, or is enrolled or has participated in any other clinical study involving an investigational intervention and received investigational treatment or used an investigational device within 4 weeks of the first dose of dostarlimab. * Participant is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study intervention. * Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

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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 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.