RecruitingPhase 2NCT06502743

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

Phase 2 Study of 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


Sponsor

Yonsei University

Enrollment

92 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a PARP inhibitor (nesuparib) to standard maintenance immunotherapy (pembrolizumab) after chemotherapy improves outcomes for women with advanced or recurrent endometrial (uterine) cancer that has a normal DNA repair system (called MMR-proficient or pMMR). **You may be eligible if...** - You are a woman aged 19 or older - You have advanced (stage III–IV) or recurrent endometrial cancer confirmed by biopsy - Your tumor has been tested and found to be MMR-proficient (normal DNA repair) - You have not had chemotherapy for advanced disease before (or completed it as an adjuvant treatment at least 12 months ago) - You have good overall health (ECOG score 0–2) - Your blood counts, liver, kidney, and thyroid function are at acceptable levels **You may NOT be eligible if...** - You have previously been treated with a PARP inhibitor - Your tumor is MMR-deficient (abnormal DNA repair system) - You have active brain metastases (some treated cases may be acceptable) - You have a serious autoimmune condition, severe infection, or significant heart problems - You have HIV, active hepatitis B or C, or a history of myelodysplastic syndrome - You are pregnant or breastfeeding - You have had an organ transplant 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

DRUGNesuparib

Nesuparib 150mg or 100mg, QD, PO

DRUGPembrolizumab

Pembrolizumab 400mg, IV, Q6W


Locations(6)

National Cancer Center

Kyeonggi-do, South Korea

Severance hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul Asan Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06502743


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