Last updated: 06/11/2025 14:01:22
Comparison of outcomes between dostarlimab and current available treatments 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: This study will compare and describe the efficacy of dostarlimab against the effectiveness of alternative treatments (current United Kingdom [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 8 months
Secondary outcomes:
Progression free survival
Timeframe: Up to 8 months
Time on treatment
Timeframe: Up to 8 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-09-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Scott Goulden, Kiera Heffernan, Fulya Sen Nikitas, Urmi Shukla, Craig Knott, Matthias Hunger, Ankit Pahwa, Rene Schade. Outcomes of dostarlimab versus chemotherapy in post-platinum patients with recurrent/advanced endometrial cancer: data from the GARNET trial and the National Cancer Registration Service in England.. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society.
DOI: 10.1136/ijgc-2022-004178
PMID: 37620100
Medical condition
Neoplasms, Endometrial
Product
Not applicable
Collaborators
NA
Study date(s)
April 2021 to May 2022
Type
Observational
Phase
1
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- GARNET trial
- Participants are women 18 years of age or older who were diagnosed with advanced (>= stage IIIB) or recurrent EC, progressed on or after platinum doublet therapy.
- GARNET trial
- Participant had received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Inclusion and exclusion criteria
Inclusion criteria:
- GARNET trial
- Participants are women 18 years of age or older who were diagnosed with advanced (>= stage IIIB) or recurrent EC, progressed on or after platinum doublet therapy.
- Received no more than 2 lines of anti-cancer systemic chemotherapy for recurrent or advanced disease (hormone monotherapy does not count towards a line).
- Eastern Cooperative Oncology Group (ECOG) performance status at Baseline <=1.
- Tumor type of dMMR (by immunohistochemistry) or in the absence of known MMR status, MSI-H (by next generation sequencing [NGS] or polymerase chain reaction [PCR]). GARNET-like real world EC cohort
- 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.
- Aged >=18 years at the point of advanced or recurrent diagnosis.
- 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.
- A histology that excludes endometrial sarcoma and carcinosarcoma.
Exclusion criteria:
- GARNET trial
- Participant had received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Participant had 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 had a 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 had a known history of human immunodeficiency virus (HIV).
- Participant had known active hepatitis B or C.
- Participant had an active autoimmune disease that had required systemic treatment in the past 2 years.
- Participant had 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 real world EC cohort
- 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.
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
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
2022-09-05
Actual study completion date
2022-09-05
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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