Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502743
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-23
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PENELOPE
Brief 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 11
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 11
Detailed Description:
Part ASafety Run-in Phase - Pembrolizumab paclitaxel carboplatin followed by pembrolizumab combination with nesuparib
Part BRandomization Phase
- Pembrolizumab p aclitaxel Carboplatin followed by Pembrolizumab combination with Nesuparib vs Pembrolizumab Paclitaxel Carboplatin followed by Pembrolizumab monotherapy
Part BRandomization Phase
- Pembrolizumab p aclitaxel Carboplatin followed by Pembrolizumab combination with Nesuparib vs Pembrolizumab Paclitaxel Carboplatin followed by Pembrolizumab monotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None