A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advance… (NCT07652515) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer
100 participantsStarted 2026-08-17
Plain-language summary
This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 disea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 4 trial, dostarlimab has already been approved in some settings — can you explain what is already known about its safety profile, and what this study is specifically trying to learn about Indian patients that isn't already established?
2The trial is measuring serious side effects — Grade 3 or higher — over about 49 weeks. What kinds of severe reactions have been seen with dostarlimab in earlier studies, and how would those be managed if they happened to me?
3This trial is not yet recruiting, so it may be some time before it opens. Given my diagnosis of advanced or recurrent endometrial cancer, would waiting for this trial to begin be safe, or should we consider starting standard treatment now?
4Since this study is being conducted specifically in India, are there any differences in how dostarlimab's safety might be evaluated or reported here compared to trials done elsewhere, and does that affect how I should think about the results?
5Would my tumor's mismatch repair or microsatellite instability status affect whether this trial — or dostarlimab more broadly — might be a relevant option worth discussing with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49