protocolSection identificationModule nctId: NCT06278857, orgStudyIdInfo id: QCGC-001/2023, briefTitle: SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr), acronym: SATELLITE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Queensland Centre for Gynaecological Cancer, class: OTHER_GOV, collaborators name: GlaxoSmithKline Research & Development Limited, descriptionModule briefSummary: 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., conditionsModule conditions: Endometrial Cancer Stage I, conditions: Mmr Deficiency, conditions: Endometrioid Endometrial Adenocarcinoma, conditions: Immune-related Adverse Event, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a non-randomised, prospective, pilot, open-label, single arm study. Participation in this trial involves seven dostarlimab sessions over 12 months, with a treatment protocol of four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI], outcomesModule primaryOutcomes measure: Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab., secondaryOutcomes measure: Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma., secondaryOutcomes measure: TEAEs/irAEIs Leading to Study Drug Discontinuation, secondaryOutcomes measure: TEAEs/irAEIs Leading to Study Withdrawal, secondaryOutcomes measure: Clinically Significant Changes in Haematology, secondaryOutcomes measure: Clinically Significant Changes in Clinical Chemistry, secondaryOutcomes measure: Clinically Significant Changes in Thyroid Function, secondaryOutcomes measure: Abnormal Vital Signs, secondaryOutcomes measure: Abnormal Electrocardiogram (ECG) Parameters, secondaryOutcomes measure: Clinically Significant Abnormal Physical Examination, secondaryOutcomes measure: Concomitant Medications, otherOutcomes measure: Study Feasibility Outcome: Recruitment Rate, otherOutcomes measure: Study Feasibility Outcome: Rationale for Treatment Discontinuation, otherOutcomes measure: Study Feasibility Outcome: Study Withdrawal Rate, otherOutcomes measure: Study Feasibility Outcome: Incidence of Immune-Related Adverse Events (irAEs), otherOutcomes measure: Study Feasibility Outcome: Number of Cycles of dostarlimab Completed, otherOutcomes measure: Qualitative Evaluation by Semi-Structured Interview to gather valuable consumer feedback to inform future clinical research programs., otherOutcomes measure: Participant Burden Assessment, otherOutcomes measure: Participant Burden Assessment - Adverse Events, otherOutcomes measure: Evaluation of Fertility Outcomes/Pregnancy Plans for WOCBP compare to their pre-treatment reproductive plans., otherOutcomes measure: Correlate clinical efficacy (pCR) with irAEs., otherOutcomes measure: Fertility outcome within the fertility preservation population - pregnancy rates, otherOutcomes measure: Fertility outcome within the fertility preservation population - pregnancy loss rates, otherOutcomes measure: Fertility outcome within the fertility preservation population - live birth rates, otherOutcomes measure: Fertility outcome within the fertility preservation population - rates of maternal and fetal complications/abnormalities, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westmead Hospital, city: Sydney, state: New South Wales, zip: 2145, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Alison Brand, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Royal Brisbane and Women's Hospital, city: Brisbane, state: Queensland, zip: 4029, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Vanessa Behan, role: CONTACT, phone: 07 3346 5590, email: v.behan@uq.edu.au, contacts name: Jeffrey Goh, Associate Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, locations facility: Peter MacCallum Cancer Centre, city: Melbourne, state: Victoria, zip: 3000, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Linda Mileshkin, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, hasResults: False