OncoMatch/Clinical Trials/NCT06278857

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

Is NCT06278857 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] for endometrial cancer stage i.

Phase 2RecruitingQueensland Centre for Gynaecological CancerNCT06278857Data as of May 2026

Treatment: Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] — 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.

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Extracted eligibility criteria

Cancer type

Endometrial Cancer

Biomarker criteria

Required: MLH1 loss by IHC

Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry

Required: PMS2 loss by IHC

Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry

Required: MSH2 loss by IHC

Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry

Required: MSH6 loss by IHC

Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry

Disease stage

Required: Stage I (FIGO)

Grade: 12 (FIGO)

Stage 1, FIGO grade 1 or 2

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: immunotherapy

Exception: Non-clinically significant laboratory abnormalities are not exclusionary

any immune-related AE (irAE) of Grade 3 or higher, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome), or myocarditis of any grade

Lab requirements

Blood counts

absolute neutrophil count 1.5 x 10^9/L; platelets 100 x 10^9/L; haemoglobin ≥9 g/dL

Kidney function

Creatinine < 1.5x institutional upper limits OR creatinine clearance > 30 ml/min

Liver function

total bilirubin < 1.5x institutional upper limit normal (ULN); AST/ALT < 2.5 - 3x ULN

adequate organ and bone marrow function defined as: absolute neutrophil count 1.5 x 10^9/L; platelets 100 x 10^9/L; haemoglobin ≥9 g/dL; total bilirubin < 1.5x institutional upper limit normal (ULN); AST/ALT < 2.5 - 3x ULN; Creatinine < 1.5x institutional upper limits OR creatinine clearance > 30 ml/min; INR or PT ≤ 1.5 x ULN unless the participant is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulants; aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulant

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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