Last updated: 03/05/2025 07:20:18
Comparison between dostarlimab and current available treatments for participants with 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: Comparison of outcomes between dostarlimab and current available treatments in US patients with recurrent/advanced endometrial cancer using a real-world synthetic control arm
Trial description: This study aims to compare clinical outcomes between dostarlimab (investigational drug) and historically treated participants using the external real-world cohort as a potential synthetic control arm, in recurrent or advanced endometrial cancer (EC) participants who have progressed on or after no more than 2 prior lines of systemic chemotherapy for advanced or recurrent disease with at least one of them being platinum-based therapy.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall survival of participants receiving dostarlimab
Timeframe: Up to 2 years
Overall survival of participants receiving real-world therapy
Timeframe: Up to 2 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2021-15-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Goulden S, Shen Q, Coleman R, Mathews C, Hunger M, Pahwa A, et al. Outcomes for dostarlimab and real-world treatments in post-platinum patients with advanced/recurrent endometrial cancer: the GARNET trial versus a US electronic health record-based external control arm. J Health Econ Outcomes Res.
DOI: 10.36469/001c.77484
PMID: 37701519
Medical condition
Neoplasms, Endometrial
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2021 to June 2021
Type
Observational
Phase
1
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- For GARNET Part 2B Cohort A1:
- Participant at least 18 years of age.
- For GARNET Part 2B Cohort A1:
- Participant had received prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed death ligand 1 (anti-PD-L1), or anti-Programmed death ligand 2 (anti-PD-L2) agent.
Inclusion and exclusion criteria
Inclusion criteria:
- For GARNET Part 2B Cohort A1:
- Participant at least 18 years of age.
- Participant had proven recurrent or advanced solid tumor and disease progression after treatment with available anticancer therapies or was intolerant to treatment that met the requirements for the part of the study in which they participated.
- Part 2B: Histologically of cytologically proven recurrent or advanced solid tumor with measurable lesion(s) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and met one of the following disease types: The criteria below were met for participants participating in Cohort A1.
- Participants with deficient Mismatch Repair/Microsatellite Instability-High (dMMR/MSI-H) EC and
- Participants had progressed on or after platinum doublet therapy;
- Participants had received no more than 2 lines of anticancer therapy for recurrent or advanced (greater than equal to [>=] Stage III B) disease. Prior treatment with hormone therapies was acceptable and did not count toward the number of anticancer therapies noted in the criterion above for this cohort;
- All EC histologies were allowed, except endometrial sarcoma (including carcinosarcoma);
- Participants submitted 2 scans demonstrating an increase in tumor measurement that met criteria for progressive disease (PD) on or after the latest systemic anticancer therapy based on RECIST v1.1 to Central Radiology prior to the first dose of dostarlimab;
- Presence of at least 1 measurable lesion on Baseline scan was confirmed by Central Radiology review;
- Status of tumor Mismatch Repair/Microsatellite Instability (MMR/MSI): Participants could be screened based on local MMR/MSI testing results using immunohistochemistry (IHC), polymerase chain reaction (PCR), or next generation sequencing (NGS) performed in a certified local laboratory, but participant eligibility was determined by MMR IHC results. For participants with available local MMR IHC results for the respective cohort(s), tumor samples were submitted to a central IHC laboratory, and the quality was checked and cleared prior to Cycle 1/Day 1. For participants without available local MMR IHC test results (i.e., Participants with local PCR or NGS test results), tumor samples were submitted directly to a central IHC laboratory, and the central IHC results confirmed eligibility prior to proceeding with other screening procedures. After the central IHC test was completed, remaining tumor tissue may have been sent to a central NGS laboratory for further testing.
- Participant had an Eastern Cooperative Oncology Group (ECOG) performance status of less than equal to (<=) 1.
- For Real world Cohort:
- Woman at least 18 years of age.
- Participant had proven recurrent or advanced (>=Stage IIIB) solid EC.
- Some participants could receive platinum single regimen or platinum triplet, but the majority of real-world participants received platinum doublet.
- Participants had received no more than 2 lines of anticancer 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).
- Real-world cohort includes participants regardless of MMR/MSI status.
- ECOG status of 1 or less at Index date (ECOG within 30 days prior & up to 7 days after the Index Date will be considered in real-world cohort due to ECOG not being tested regularly in the real world).
Exclusion criteria:
- For GARNET Part 2B Cohort A1:
- Participant had received prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed death ligand 1 (anti-PD-L1), or anti-Programmed death ligand 2 (anti-PD-L2) agent.
- Participant had known uncontrolled central nervous system metastases and/or carcinomatous meningitis.
- 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 was considered a poor medical risk due to a serious, uncontrolled medical disorder; a non-malignant systemic disease; or an active infection requiring systemic therapy. Specific examples included, but were not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would have interfered with cooperation with the requirements of the study (including obtaining informed consent).
- Participant was pregnant or breastfeeding, or expected to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment.
- 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) (HIV 1/2 antibodies).
- Participant had known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative] was detected).
- Participant had an active autoimmune disease that had required systemic treatment in the past 2 years (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) was not considered a form of systemic treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops were allowed.
- 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.
- Participant had participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks prior to the first dose of study drug.
- Participant had received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half-life of the most recent therapy prior to study Day 1, whichever was shorter.
- Participant had not recovered adequately (Grade <=1) from AEs and/or complications from any major surgery prior to starting therapy.
- Participant had received a live vaccine within 14 days of the planned start of study treatment.
- Participant had a known hypersensitivity to dostarlimab components or excipients.
- For Real world Cohort:
- 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.
- In real world cohort, time-frame is any time before the EC treatment.
- Participant had a known history of 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.
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
2021-15-06
Actual study completion date
2021-15-06
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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