Last updated: 03/07/2025 08:41:33
Comparison of outcomes between dostarlimab and current available treatments in the United Kingdom (UK) using a real world synthetic control arm
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Comparison of outcomes between dostarlimab and current available treatments in UK patients with recurrent/advanced endometrial cancer using a real world synthetic control arm
Trial description: The purpose of this study is to compare the efficacy of dostarlimab against the effectiveness of alternative treatments (current UK treatment paradigms) using an adjusted comparison method.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall survival
Timeframe: Up to 4 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-20-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Endometrial
Product
Not applicable
Collaborators
NA
Study date(s)
September 2021 to October 2021
Type
Observational
Phase
1
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Inclusion Criteria:
- GARNET trial:
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria: GARNET trial:
- Women with at least 18 years age.
- Participants were diagnosed with proven recurrent or advanced (greater than or equal to [>=] stage IIIB) or soild EC.
- Participants with progressed on or after platinum doublet therapy.
- Participants who received no more than 2 lines of anti-cancer therapy for recurrent or advanced (>=Stage III B) disease. Prior treatment with hormone therapies was acceptable and did not count toward the number of anticancer therapies.
- All EC histologies were allowed, except endometrial sarcoma (including carcinosarcoma).
- Status of tumor Mismatch repair (MMR)/Microsatellite instability (MSI): Deficient mismatch repair (dMMR) (by immunohistochemistry [IHC]) or, in the absence of known MMR status, Microsatellite instability high (MSI-H) (by next generation sequencing [NGS] or polymerase chain reaction [PCR]).
- Eastern Cooperative Oncology Group (ECOG) performance status at Baseline less than or equal to (<=)1. GARNET-like cohort (RWE):
- Participants residing in England at the date of diagnosis.
- At least one incident primary diagnosis of advanced or recurrent EC between 01-Jan-2013 and 31-Dec-2018;
- Participants with age 18 years or above at the date of advanced diagnosis or recurrent disease.
- Participants that presented with stage I/II disease and experienced a probable recurrence (index date equal to date of recurrence).
- Or participants that presented with stage III or IV disease (index date equal to the date of diagnosis).
- Confirmed receipt of platinum-doublet therapy.
- Prior treatment with hormone therapies will be acceptable and will not count towards lines of therapy.
- No evidence of having received any anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1(PD-L1), or anti-PD-L2 therapy, e.g.: atezolizumab, avelumab, cemiplimab, durvalumab, nivolumab, pembrolizumab, bevacizumab.
- Excluding any participant with a record of another primary malignancy, except for non-melanoma skin cancer (C44) and carcinoma in situ cervix (D06). Non- cohort-relevant primaries will be considered if dated after or up to 18 months before the selected primary of interest.
- A histology that excludes endometrial sarcoma and carcinosarcoma. Exclusion Criteria GARNET trial:
- Participant who received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Participant with a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions included basal cell carcinoma of the skin, squamous cell carcinoma of the skin that had undergone potentially curative therapy, or in situ cervical cancer.
- Participant with diagnosis of immunodeficiency or was receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Participant with known history of human immunodeficiency virus (HIV).
- Participant with known active hepatitis B or C.
- Participant with an active autoimmune disease that had required systemic treatment in the past 2 years.
- Participants not recovered (i.e., to Grade <=1 or to Baseline) from radiation- and chemotherapy-induced adverse events (AEs) or received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 3 weeks prior to the first dose of study drug. GARNET-like cohort (RWE):
- Diagnoses via death certificate only.
- No recorded stage at diagnosis such that advanced and recurrent disease cannot be reliably differentiated
- No recorded age at diagnosis.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
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
2021-20-10
Actual study completion date
2021-20-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website