At a glance
ClinicalIndex Comparison Record- ✓Female ≥19 years of age
- ✓Histologically confirmed endometrial cancer (specific types eligible)
- ✓Measurable stage III, measurable stage IVA, stage IVB or recurrent endometrial cancer
- ✓MMR proficient confirmed by institutional MMR IHC testing
- ✕Prior treatment with PARP inhibitor
- ✕Known hypersensitivity to nesuparib, pembrolizumab, or chemotherapy components
- ✕MMR deficiency confirmed by institutional MMR IHC testing
- ✕Currently participating in cancer-directed investigational therapy or received such therapy within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Nesuparib and Pembrolizumab for Endometrial Cancer and 4 related conditions. Currently recruiting, targeting 92 participants across 6 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Nesuparib 150mg or 100mg, QD, PO
Pembrolizumab 400mg, IV, Q6W