Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602063
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Surgery for Ovarian Cancer After PARPi Therapy in Precision
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Surgery with ICBs in BRCAwt CD8 TILs 1st Relapsed Ovarian Cancer After PARPi Maintenance Therapy a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This multicenter biomarker-driven patient-centric study aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with anti-PD1 therapy in patients with platinum-sensitive relapsed ovarian cancer PSROC after previous PARP inhibitor maintenance therapy
Detailed Description:
There have been fewer effective treatments for patients with disease progression occurring during or after PARP inhibitor maintenance therapy The immune phenotype of patients with relapsed ovarian cancer may correlate with their response to immunotherapy This multicenter biomarker-driven patient-centric study aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with anti-PD1 therapy in patients with platinum-sensitive relapsed ovarian cancer PSROC after previous PARP inhibitor maintenance therapy PD-L1 expression and CD8 tumor-infiltrating T cell count CD8 TILs count were evaluated as biomarkers using archived or fresh tumor tissue samples in patients with BRCA12 wild type
This study would be proceeded in two phases The phase 1b single-arm study aimed to evaluate the efficacy of Sintilimab in the treatment of BRCA wild type PD-L1-positive CD8 TILs-positive patients with PSROC after previous PARPi maintenance therapy The patent-centric phase II study with three arms aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with Sintilimab in these patients In arm 1 and 2 patients received secondary cytoreduction followed by platinum-based chemotherapy in combination with Sintilimab In arm 3 patients received physicians therapy of choice
This study would be proceeded in two phases The phase 1b single-arm study aimed to evaluate the efficacy of Sintilimab in the treatment of BRCA wild type PD-L1-positive CD8 TILs-positive patients with PSROC after previous PARPi maintenance therapy The patent-centric phase II study with three arms aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with Sintilimab in these patients In arm 1 and 2 patients received secondary cytoreduction followed by platinum-based chemotherapy in combination with Sintilimab In arm 3 patients received physicians therapy of choice
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