Last updated: 09/28/2026 17:51:05
Clinical and Economic Outcomes among Participants with. Endometrial Cancer Receiving Chemotherapy in Combination with Immunotherapy
GSK study ID
309673
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Clinical and Economic Outcomes among Patients with Primary Advanced or Recurrent Endometrial Cancer Receiving Chemotherapy in Combination with Immunotherapy
Trial description: This study will examine treatment patterns, Adverse Events (AE) profiles, and healthcare resource utilization and expenditure among participants with Primary advanced or recurrent (pA/R) Endometrial cancer (EC) receiving carboplatin and paclitaxel in combination with either dostarlimab or pembrolizumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants categorized by treatment patterns
Timeframe: Up to approximately 42 months
Secondary outcomes:
Proportion of participants with Overall Adverse Events and by Type
Timeframe: Up to approximately 42 months
Rate of Overall Adverse Events per 100 person-years and by type
Timeframe: Up to approximately 42 months
Assessment of health care resource utilization and expenditure
Timeframe: Up to approximately 42 months
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2027-29-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Endometrial
Product
Dostarlimab
Collaborators
The Ohio State University and the James Comprehensive Cancer Center
Study date(s)
November 2026 to April 2027
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Participants with presence of greater than or equal to (>=)1 inpatient or >=2 outpatient (on separate dates within 365 days) medical claims with an International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis code for EC (in the primary diagnostic position for inpatient claims, and in any diagnostic position for outpatient claims) and in any setting of care between 01 January 2021 and 31 December 2024 (Medicare FFS) or 30 September 2025 (MORE)
- Participants with evidence of chemotherapy in combination with immunotherapy, defined as >=1 claim for each of carboplatin, paclitaxel and dostarlimab within 42 days of the earliest claim or >=1 claim for each of carboplatin, paclitaxel and pembrolizumab within 42 days of the earliest claim, following the diagnostic index between 01 April 2023 and 31 December 2024 (Medicare Fee-for-service[FFS]) or 30 September 2025 (MORE)
- Participants with >=1 inpatient or >=2 outpatient medical claims (on separate dates within 365 days) with an ICD-10-CM diagnosis code for another primary cancer other than basal or squamous cell carcinoma during the baseline period
- Participants with evidence of participation in a clinical trial during the baseline period via the presence of specific ICD-10-CM codes for clinical trial enrollment
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with evidence of chemotherapy in combination with immunotherapy, defined as >=1 claim for each of carboplatin, paclitaxel and dostarlimab within 42 days of the earliest claim or >=1 claim for each of carboplatin, paclitaxel and pembrolizumab within 42 days of the earliest claim, following the diagnostic index between 01 April 2023 and 31 December 2024 (Medicare Fee-for-service[FFS]) or 30 September 2025 (MORE)
- Participants with at least 12 months of active health insurance coverage (continuous enrollment) with medical benefits preceding treatment index; for participants with an interval >12 months between the diagnostic and treatment index, continuous enrollment will be required through the entirety of this period
- Participants with absence of claims for carboplatin, paclitaxel, dostarlimab or pembrolizumab in the 6-month period preceding the treatment index date
- Participants with age >=18 years on the treatment index date
Participants with presence of greater than or equal to (>=)1 inpatient or >=2 outpatient (on separate dates within 365 days) medical claims with an International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis code for EC (in the primary diagnostic position for inpatient claims, and in any diagnostic position for outpatient claims) and in any setting of care between 01 January 2021 and 31 December 2024 (Medicare FFS) or 30 September 2025 (MORE)
Exclusion criteria:
- Participants with evidence of participation in a clinical trial during the baseline period via the presence of specific ICD-10-CM codes for clinical trial enrollment
Participants with >=1 inpatient or >=2 outpatient medical claims (on separate dates within 365 days) with an ICD-10-CM diagnosis code for another primary cancer other than basal or squamous cell carcinoma during the baseline period
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
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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