Trials / Recruiting
RecruitingNCT06502743
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Endometrial Cancer
- Recurrent Endometrial Carcinoma
- Endometrial Carcinoma
- Gynecologycal Cancer
- Endometrial Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nesuparib | Nesuparib 150mg or 100mg, QD, PO |
| DRUG | Pembrolizumab | Pembrolizumab 400mg, IV, Q6W |
Timeline
- Start date
- 2024-09-12
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2024-07-16
- Last updated
- 2025-04-03
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06502743. Inclusion in this directory is not an endorsement.