Actively Recruiting
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
Led by Yonsei University · Updated on 2025-04-03
92
Participants Needed
6
Research Sites
167 weeks
Total Duration
On this page
Sponsors
Y
Yonsei University
Lead Sponsor
O
Onconic Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 19 years or older
- Histologic confirmation of endometrial cancer including endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, or adenocarcinoma not otherwise specified
- Measurable stage III, IVA, IVB, or recurrent endometrial cancer
- MMR proficient confirmed by local immunohistochemistry testing
- Available P53 immunohistochemistry result
- Nafve to first-line systemic anticancer treatment or prior adjuvant chemotherapy completed at least 12 months before randomization for recurrent cases
- Completed prior radiation therapy at least 4 weeks before randomization
- Discontinued prior hormonal therapy at least 3 weeks before randomization
- Archival tumor tissue available or fresh biopsy obtained before randomization
- ECOG performance status of 0, 1, or 2
- Adequate organ function within 7 days before starting study treatment
- Provided written informed consent
- Women of childbearing potential agree to use effective contraception from 14 days before randomization through specified periods after last doses
- Considered nonreproductive if postmenopausal, had specific gynecological surgeries, or have conditions preventing childbearing
You will not qualify if you...
- Prior treatment with a PARP inhibitor
- Known allergy to nesuparib, pembrolizumab, or chemotherapy components
- MMR deficiency confirmed by local testing
- Participation in another cancer-directed study or treatment within 4 weeks before randomization
- Active central nervous system metastases or carcinomatous meningitis
- Additional malignancy requiring active treatment or progression within last 2 years with exceptions
- Receipt of live vaccine within 30 days before first study dose
- Immunodeficiency or recent systemic immunosuppressive therapy
- History or current pneumonitis requiring steroids
- Uncontrolled illnesses including active infection or heart conditions
- Known HIV infection
- Active Hepatitis B or C infection
- Inability to swallow oral medication or gastrointestinal absorption issues
- History of myelodysplastic syndrome or acute myeloid leukemia
- Systemic autoimmune disease
- Not recovered from major surgery or ongoing surgical complications
- Conditions or circumstances interfering with study participation
- Psychiatric or substance abuse disorders interfering with compliance
- Pregnant, breastfeeding, or planning pregnancy during study
- History of allogenic tissue or solid organ transplant
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Trial Site Locations
Total: 6 locations
1
National Cancer Center
Kyeonggi-do, South Korea
Actively Recruiting
2
Severance hospital
Seoul, South Korea, 03722
Actively Recruiting
3
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
4
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
5
Seoul Asan Medical Center
Seoul, South Korea
Actively Recruiting
6
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
JUNGYUN LEE, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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