OncoMatch/Clinical Trials/NCT06502743
First-line Carboplatin and Paclitaxel in Combination With Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient (pMMR) Endometrial Cancer
Is NCT06502743 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nesuparib and Pembrolizumab for endometrial cancer.
Treatment: Nesuparib · Pembrolizumab — The goal of this study is listed below. Part A (Safety Run-in Phase) : To determine feasibility of pembrolizumab and nesuparib combination as maintenance therapy in patients with MMR-proficient advanced and recurrent endometrial cancer. Feasibility is defined as a dose-limiting toxicity (DLT) rate less than or equal to 33%. Part B (Randomization Phase) : To evaluate the efficacy of pembrolizumab and nesuparib combination/ pembrolizumab monotherapy as maintenance therapy in patients with MMR-proficient advanced stage and recurrent endometrial cancer. Efficacy will be assessed by investigator assessed progression free survival (PFS) as assessed by RECIST 1.1.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: MMR proficient
MMR proficient confirmed by institutional (local) MMR IHC testing.
Required: TP53 IHC result required
Patient must provide the institutional (local) P53 IHC result.
Excluded: MMR deficiency
MMR deficiency confirmed by institutional MMR IHC testing.
Disease stage
Required: Stage III, IVA, IVB
Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: PARP inhibitor
Patient has undergone prior treatment with a known PARP inhibitor.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,500/μL without growth factor support within 2 weeks before screening test. Platelet ≥100,000/μL without transfusion within 2 weeks prior to screening test. Hemoglobin ≥10.0 g/dL without transfusion within 2 weeks prior to screening test.
Kidney function
Creatinine or measured or calculated creatinine clearance (GFR may also be used in place of creatinine or CrCl a) ≤1.5 × ULN or ≥30 mL/min for subjects with creatinine levels >1.5 × institutional ULN.
Liver function
Total bilirubin ≤1.5×ULN or direct bilirubin ≤ULN for subjects whose total bilirubin exceeds 1.5 times the normal value. AST (SGOT) and ALT (SGPT) ≤3 × ULN (≤5 × ULN in subjects with liver metastases)
Have adequate organ function. Specimens must be collected within 7days prior to the start of study intervention. Hematology Absolute neutrophil count (ANC) ≥1,500/μL without growth factor support within 2 weeks before screening test. Platelet ≥100,000/μL without transfusion within 2 weeks prior to screening test. Hemoglobin ≥10.0 g/dL without transfusion within 2 weeks prior to screening test. Kidney function Creatinine or measured or calculated creatinine clearance (GFR may also be used in place of creatinine or CrCl a) ≤1.5 × ULN or ≥30 mL/min for subjects with creatinine levels >1.5 × institutional ULN. liver function Total bilirubin ≤1.5×ULN or direct bilirubin ≤ULN for subjects whose total bilirubin exceeds 1.5 times the normal value. AST (SGOT) and ALT (SGPT) ≤3 × ULN (≤5 × ULN in subjects with liver metastases)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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