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

Recruiting Phase 2 Interventional Study
Endometrial Cancer Recurrent Endometrial Carcinoma Endometrial Carcinoma Gynecologycal Cancer Endometrial Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
92 (estimated)
Sponsor
Yonsei University · Other
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About This Trial
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 pembrolizuma…
Trial Locations
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Eligibility Criteria
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,…
Contacts

JUNGYUN LEE, Ph.D

82)2-2228-2237

JUNGYUNLEE@yuhs.ac

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