The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.
Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.
This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.
Female participant is at least 18 years of age (at the time of informed consent).
Participant has an ECOG performance status of ≤ 2
Participant demonstrates no evidence of extrauterine disease assessed from all available clinical evidence (physical examination findings) and medical imaging including standard of care diagnostic CT, MRI, ultrasound, or X-ray and screening gadolinium contrast pelvic MRI
A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be rescreened once, at the Investigator's discretion, and may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors to the participant and will not interfere with the study procedures.
Participant has a histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-risk endometrial e.g., papillary serous, clear cell).
Participant is pregnant, breastfeeding, or planning to become pregnant during the trial period.
Participant has had an allogeneic tissue/solid organ transplant.
Participants with uncontrolled hypertension, history of hypertension crisis, history of hypertensive encephalopathy, QTc>450 at baseline, other severe cardiovascular diseases including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, New York Heart Association (NYHA) class III and IV heart failure and uncontrolled arrhythmia within the past 6 months. Rate-controlled arrhythmia may be eligible at the discretion of the Investigator.
Single group
Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]
DrugThe dosing regimen follows standard clinical care protocol comprising of 4 cycles every 3-weeks, a rest period of 34 weeks followed by 3 cycles every 6 weekly for a total of 7 cycles.
Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab.
Number of participants achieving investigator-assessed pathological complete response (pCR).
Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma.
Safety analyses including incidence of treatment-emergent adverse events (TEAEs), immune-related AEs of interest (irAEIs), and serious adverse events (SAEs), toxicities graded 3-5 as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0).
TEAEs/irAEIs Leading to Study Drug Discontinuation
Explore the frequency and severity of TEAEs/irAEIs that lead to discontinuation of the study drug.
TEAEs/irAEIs Leading to Study Withdrawal
Investigate and assess the frequency and severity of TEAEs/irAEIs resulting in the withdrawal of participants from the study.
Clinically Significant Changes in Haematology
Assess the number of participants with clinically significant changes in Haematology
Study Feasibility Outcome: Recruitment Rate
Evaluates the pace of participant recruitment in the study by comparing the number of enrolments per time unit with the set recruitment objectives.
Study Feasibility Outcome: Rationale for Treatment Discontinuation
Evaluates the number of participants who withdraw from the study and the reasons behind treatment discontinuation.
Study Feasibility Outcome: Study Withdrawal Rate
Calculate the percentage of participants who withdraw from the study, irrespective of the reason, to understand the overall attrition rate.
Study Feasibility Outcome: Incidence of Immune-Related Adverse Events (irAEs)
Calculate the ratio of participants experiencing irAEs to the total number of participants, providing insights into the safety profile of the treatment.
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Queensland Centre for Gynaecological Cancer
Lead sponsor
GlaxoSmithKline
Collaborator
