Last updated: 11/07/2022 10:30:34
Comparative clinical effectiveness of dostarlimab for the treatment of advanced and recurrent endometrial cancer
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Comparative clinical effectiveness of dostarlimab in the treatment of advanced and recurrent endometrial cancer, based on the GARNET March 2020 data-cut using external control data (doxorubicin)
Trial description: The aim of this analysis is to compare and describe the efficacy and safety of dostarlimab against doxorubicin based on an external control using inverse probability of treatment weighting (IPTW).
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall survival (OS)
Timeframe: Up to 4.5 months
Secondary outcomes:
Progression-free survival (PFS)
Timeframe: Up to 4.5 months
Objective response rate (ORR)
Timeframe: Up to 4.5 months
Duration of response (DOR)
Timeframe: Up to 4.5 months
Time-to-deterioration (TTD) of global quality-of-life (QoL) scores
Timeframe: Up to 4.5 months
Percentage of participants experiencing treatment-emergent AE (TEAE) leading to discontinuation and serious adverse events (SAEs)
Timeframe: Up to 4.5 months
Percentage of participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher TEAEs
Timeframe: Up to 4.5 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-27-04
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Mathews C, Lorusso D, Coleman R, Boklage S, Garside J. An Indirect Comparison of the Efficacy and Safety of Dostarlimab and Doxorubicin for the Treatment of Advanced and Recurrent Endometrial Cancer. Oncologist. 2022;
DOI: 10.1093/oncolo/oyac188
PMID: 36124638
Medical condition
Neoplasms, Endometrial
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2020 to April 2021
Type
Observational
Phase
1
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Inclusion and Exclusion Criteria of GARNET (dostarlimab) and ZoptEC (doxorubicin) will be followed for this retrospective data analysis.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion and Exclusion Criteria of GARNET (dostarlimab) and ZoptEC (doxorubicin) will be followed for this retrospective data analysis.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2021-27-04
Actual study completion date
2021-27-04
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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