Actively Recruiting

Phase 2
Age: 19Years +
FEMALE
ID06502743

Phase 2 Study of First-line Carboplatin and Paclitaxel with Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient Endometrial Cancer

Led by Yonsei University · Updated on 2025-04-03

92

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yonsei University

Lead Sponsor

O

Onconic Therapeutics Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a combination of pembrolizumab and nesuparib as a maintenance therapy for female patients with MMR-proficient advanced and recurrent endometrial cancer. The study includes a safety run-in phase to assess whether the treatment is tolerable and a randomized phase to compare the effectiveness of pembrolizumab alone versus pembrolizumab with nesuparib. The main goal is to understand how these treatments affect progression-free survival. Participants receive first-line chemotherapy with pembrolizumab, paclitaxel, and carboplatin for six cycles, followed by maintenance treatment. During maintenance, one group receives pembrolizumab alone, while another receives pembrolizumab combined with nesuparib taken orally daily. Pembrolizumab is given intravenously every six weeks, and the treatment period includes up to 14 maintenance cycles. The study has two parts: an initial safety phase and a randomized phase comparing the two maintenance treatments. Throughout the study, participants will have regular assessments including monitoring for dose-limiting toxicities, tumor response evaluations, and survival outcomes. Blood tests and tumor tissue samples are collected to check organ function and molecular markers. Safety and treatment effects will be followed up for up to 18 months after enrollment. The total number of pembrolizumab cycles, including chemotherapy and maintenance, can be up to 20. Participants will be closely monitored for side effects and disease progression during the trial.

CONDITIONS

Brief 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

Age: 19Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be female aged 19 years or older
  • Histologic confirmation of specified endometrial cancer types 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 proficiency confirmed by local testing
  • Provide institutional P53 IHC result
  • Nafve to first-line systemic anti-cancer treatment or prior adjuvant chemotherapy completed at least 12 months before randomization for recurrent disease
  • Prior radiation therapy completed at least 4 weeks before randomization
  • Prior hormonal therapy discontinued at least 3 weeks before randomization
  • Archival tumor tissue available or fresh biopsy prior to randomization
  • ECOG performance status 0, 1, or 2
  • Adequate organ function within 7 days before study intervention
  • Provide written informed consent
  • Women of childbearing potential must agree to use contraception from 14 days before randomization through specified periods after last doses
  • Women must be postmenopausal, surgically sterile, or have a condition preventing childbearing
Not Eligible

You will not qualify if you...

  • Prior treatment with any PARP inhibitor
  • Known allergy to nesuparib, pembrolizumab, or chemotherapy components
  • MMR deficiency confirmed by local testing
  • Receiving cancer-directed study therapy or investigational agent within 4 weeks before randomization
  • Active central nervous system metastases or carcinomatous meningitis unless stable after treatment
  • Known additional malignancy requiring treatment within last 2 years except certain skin and cervical cancers
  • Live vaccine within 30 days before first study dose
  • Diagnosis of immunodeficiency or recent systemic immunosuppressive therapy
  • History of pneumonitis requiring steroids or current pneumonitis
  • Uncontrolled illness including infection, lung disease, heart failure, angina, arrhythmia, or psychiatric/social issues
  • Known HIV infection
  • History or active Hepatitis B or C infection
  • Unable to swallow oral medication or gastrointestinal disorders affecting absorption
  • History or current diagnosis of myelodysplastic syndrome or acute myeloid leukemia
  • Systemic autoimmune diseases such as lupus
  • Not recovered from major surgery or ongoing surgical complications
  • Conditions or therapies that may interfere with study participation
  • Psychiatric or substance abuse disorders interfering with trial cooperation
  • Pregnant, breastfeeding, or planning pregnancy during study and follow-up periods
  • Prior allogenic tissue or solid organ transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 12 months (6 cycles of chemotherapy followed by up to 14 cycles of maintenance treatment)

Participants receive chemotherapy with pembrolizumab, paclitaxel, and carboplatin for up to 6 cycles, followed by maintenance treatment with pembrolizumab with or without nesuparib for up to 14 cycles.

1 visit every 3 weeks during chemotherapy and 1 visit every 6 weeks during maintenance treatment

Follow-up

Duration - Up to 18 months after enrollment

Participants are monitored for progression-free survival and overall survival after completion of treatment.

Visits at 3, 6, 9, 12, and 18 months after enrollment

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

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Research Team

J

JUNGYUN LEE, Ph.D

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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Published Research Related To This Trial

Phase II randomized study of first-line carboplatin and paclitaxel in combination with pembrolizumab, followed by maintenance pembrolizumab alone or with nesuparib, in mismatch-repair proficient, advanced or recurrent endometrial cancer (PENELOPE).

Se Ik Kim, Hyun-Woong Cho, Chel Hun Choi...

https://pubmed.ncbi.nlm.nih.gov/41514313