A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Ad… (NCT06897527) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)
100 participantsStarted 2025-07-15
Plain-language summary
The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants ≥18 years of age, at the time of signing the informed consent.
* Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinum containing regimen.
* Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
* WOCBP (Women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose.
* Negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, in accordance with applicable laws.
Exclusion Criteria:
* Known active hepatic disease, End-Stage Renal Disease (ESRD) or known case of serious, uncontrolled medical disorder/active infections which precludes participant's inclusion in the study as per the investigator's judgement.
* Either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class of the study drug.
* Received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1) agent.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of st…
What they're measuring
1
Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)