Last updated: 06/16/2025 14:20:07

A study to characterize real-world effectiveness and safety of dostarlimab in participants with mismatch repair deficient (dMMR) or high microsatellite instability (MSI-H) recurrent or advanced endometrial cancer from racial and ethnic minority groups and in white participants

GSK study ID
220794
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A global, retrospective, post-authorization study to characterize real-world effectiveness and safety of dostarlimab in patients with mismatch repair deficient (dMMR) or high microsatellite instability (MSI-H) recurrent or advanced endometrial cancer from racial and ethnic minority groups and in white patients
Trial description: This is a non-interventional study with a primary aim to characterize the real-world effectiveness and safety of dostarlimab monotherapy for white and racial minorities, and for Hispanic/Latino and non-Hispanic/Latino dMMR/MSI-H advanced/recurrent endometrial cancer (EC) participants in second-line plus (2L+) setting separately.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Real-world overall response rate (rwORR)

Timeframe: Index date (date of first dostarlimab administration and earliest date that participants can be eligible) to start date of data extraction period (up to approximately 42 months)

Real-world duration of response (rwDOR)

Timeframe: Index date (date of first dostarlimab administration and earliest date that participants can be eligible) to start date of data extraction period (up to approximately 42 months)

Type, severity, seriousness, and incidence of events of interest (AEIs)

Timeframe: Index date (date of first dostarlimab administration and earliest date that participants can be eligible) to start date of data extraction period (up to approximately 42 months)

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2026-16-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Endometrial
Product
Dostarlimab
Collaborators
Not applicable
Study date(s)
December 2024 to January 2026
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Written informed consent, or consent waiver, as applicable
  • Treated with any amount of dostarlimab monotherapy for dMMR/MSI-H recurrent or advanced EC in 2L+ setting
  • Concurrent or previous enrolment in an interventional clinical trial and dosed with dostarlimab
  • Missing information on both race and ethnicity
Inclusion and exclusion criteria
Inclusion criteria:

    Written informed consent, or consent waiver, as applicable

    • Treated with any amount of dostarlimab monotherapy for dMMR/MSI-H recurrent or advanced EC in 2L+ setting
    • Age greater than or equal to (≥)18 years old at dostarlimab initiation
    • Has race or ethnicity information on records
Exclusion criteria:

    Concurrent or previous enrolment in an interventional clinical trial and dosed with dostarlimab

    • Missing information on both race and ethnicity

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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