RecruitingPhase 2NCT06278857

SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

A Phase 2b, Open-label, Single Arm, Multicentre, Pilot Study of the Efficacy, Safety and Tolerability of Dostarlimab in Women With Early-stage MMR Deficient Endometrioid Endometrial Adenocarcinoma.


Sponsor

Queensland Centre for Gynaecological Cancer

Enrollment

10 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SATELLITE) is testing whether dostarlimab — an immunotherapy drug — can treat early-stage endometrial (uterine) cancer that has a specific genetic marker called MMR deficiency, without requiring surgery. This is particularly relevant for women who wish to preserve their uterus or cannot safely undergo surgery. **You may be eligible if...** - You are 18 years or older - You have early-stage (Stage 1, FIGO grade 1 or 2) endometrial cancer that is MMR-deficient (a specific genetic finding in the tumor) - You wish to keep your uterus, or are not a suitable surgical candidate - Your imaging shows no cancer spread outside the uterus - Your organ function (blood, liver, kidney) meets the required thresholds **You may NOT be eligible if...** - Your cancer has spread beyond the uterus - Your cancer does not have the MMR-deficient marker - You have active autoimmune disease or require immunosuppressive therapy - You have poor organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]

The 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.


Locations(3)

Westmead Hospital

Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06278857


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