Last updated: 03/14/2025 06:30:28
A post-marketing surveillance (PMS) study to monitor the safety and effectiveness of Jemperli administered in Korean participants in real-world practice
GSK study ID
219220
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of Jemperli administered in Korean subjects in real-world practice
Trial description: The goal of this observational multi-centre post-marketing surveillance study is to collect the safety and effectiveness data on Jemperli used according to its approved label in a real-world practice administered in Korean participants.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with Adverse Events (AEs) / Adverse Drug Reactions (ADRs)
Timeframe: Up to 24 Weeks
Percentage of participants with unexpected AEs / ADRs
Timeframe: Up to 24 Weeks
Percentage of participants with Serious Adverse Events (SAEs) / Serious Adverse Drug Reactions (SADRs)
Timeframe: Up to 24 Weeks
Secondary outcomes:
Physician’s global assessment
Timeframe: Up to 24 Weeks
Best overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1
Timeframe: Up to 24 Weeks
Interventions:
Not applicable
Enrollment:
160
Primary completion date:
2028-13-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Neoplasms, Endometrial
Product
Dostarlimab
Collaborators
Not applicable
Study date(s)
March 2024 to December 2028
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
19+ years
Accepts healthy volunteers
No
- Treatment of adult participants with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior systemic treatment with a platinum-based chemotherapy
- Participants who will be administered with Jemperli in accordance with the product information approved in Korea
- Not applicable as there’s no contraindication of administration with the product information approved in Korea
Inclusion and exclusion criteria
Inclusion criteria:
•Treatment of adult participants with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior systemic treatment with a platinum-based chemotherapy •Participants who will be administered with Jemperli in accordance with the product information approved in Korea
Exclusion criteria:
- Not applicable as there’s no contraindication of administration with the product information approved in Korea
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
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
Additional information
Not applicable
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