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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06502743•Yonsei University

View on ClinicalTrials.gov

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.

Detailed Description

Part A(Safety Run-in Phase) - Pembrolizumab+ paclitaxel+ carboplatin followed by pembrolizumab combination with nesuparib Part B(Randomization Phase) \- Pembrolizumab+ p aclitaxel+ Carboplatin followed by Pembrolizumab combination with Nesuparib vs Pembrolizumab+ Paclitaxel+ Carboplatin followed by Pembrolizumab monotherapy

Eligibility

Age

19 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patient must be female ≥ 19 years of age
•2. Histologic confirmation of the original primary tumor is required. Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.).
•3. Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
•4. MMR proficient confirmed by institutional (local) MMR IHC testing.
•5. Patient must provide the institutional (local) P53 IHC result.
•6. Prior Therapy;
•* Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if provided adjuvant chemotherapy was completed ≥ 12 months prior to randomization.
•a. Note : For Part A(Safety lead in phase), patient who used Paclitaxel, Carboplatin and Pembrolizumab for first line systemic therapy can participate if they meet all of the following conditions. Patient must have had 6 cycles of chemotherapy; patient must have physician assessed stable disease (SD), partial response (PR), or complete response (CR) after 6 cycles of therapy and patient must be enrolled within 9 weeks of their last dose of chemotherapy (last dose is the day of the last infusion)
•* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy. All radiation therapy must be completed at least 4 weeks prior to randomization.
•* Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to randomization.
+35 more criteria

Exclusion Criteria

•1. Patient has undergone prior treatment with a known PARP inhibitor.
•2. Patient has a known hypersensitivity to nesuparib, pembrolizumab or combination cytotoxic chemotherapy components or excipients.
•3. MMR deficiency confirmed by institutional MMR IHC testing.
•4. Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to randomization.

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

Key Dates

Start Date

September 12, 2024

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

April 3, 2025

Enrollment

ESTIMATED participants

Conditions

Endometrial CancerRecurrent Endometrial CarcinomaEndometrial CarcinomaGynecologycal CancerEndometrial Neoplasms

Interventions

Nesuparib

DRUG

Pembrolizumab

DRUG

Contacts

JUNGYUN LEE, Ph.D

CONTACT

82)2-2228-2237 JUNGYUNLEE@yuhs.ac

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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