Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT03732950
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2018-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study of Pembrolizumab Monotherapy in Recurrent Ovarian Cancer of the Immunoreactive Subtype Determined by NanoString Gene Expression Profiling
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on objective response rate (ORR) as assessed by the investigator per immune related Response Evaluation Criteria in Solid Tumors (irRECIST) in patients with recurrent ovarian cancer (ROC) whose tumors show an immunoreactive gene expression signature.
SECONDARY OBJECTIVES:
I. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on progression-free survival (PFS) as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature.
II. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on PFS rate at 6, 12 and 18 months as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature.
III. To evaluate and characterize the tolerability and safety profile of the study population after being treated with pembrolizumab as monotherapy.
EXPLORATORY OBJECTIVES:
I. To assess correlations of the immunoreactive gene signature with the validated a PD-L1 immunohistochemistry (IHC) assay using Merck's proprietary 22C3 antibody and the clinical activity observed in the study population.
OUTLINE:
Participants receive pembrolizumab intravenously (IV) on day 1. Courses repeat every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 and then every 9 and 12 weeks thereafter.
I. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on objective response rate (ORR) as assessed by the investigator per immune related Response Evaluation Criteria in Solid Tumors (irRECIST) in patients with recurrent ovarian cancer (ROC) whose tumors show an immunoreactive gene expression signature.
SECONDARY OBJECTIVES:
I. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on progression-free survival (PFS) as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature.
II. To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on PFS rate at 6, 12 and 18 months as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature.
III. To evaluate and characterize the tolerability and safety profile of the study population after being treated with pembrolizumab as monotherapy.
EXPLORATORY OBJECTIVES:
I. To assess correlations of the immunoreactive gene signature with the validated a PD-L1 immunohistochemistry (IHC) assay using Merck's proprietary 22C3 antibody and the clinical activity observed in the study population.
OUTLINE:
Participants receive pembrolizumab intravenously (IV) on day 1. Courses repeat every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 and then every 9 and 12 weeks thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: