Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03310567
Status:
WITHDRAWN
Last Update Posted:
2018-10-09
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
A Phase 2 Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsors pulled out of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Expression of IDO and PD-1/L1 has been found to be increased in endometrial cancer. Expression of these markers on the tumor cells leads to immunosuppression in the micro-environment of tumors that prevents immune system from attacking and killing tumor cells. The purpose of this trial is to target these antigens by concomitant administration of drugs epacadostat and pembrolizumab, thereby removing twin mechanisms of immune-suppression that may lead to better control of tumor growth.
Detailed Description:
Primary Objective
* Evaluate the response rate (RR) and 6 month progression-free survival (PFS-6) of patients with recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab as measured by modified RECIST v1.1
* In a subset analysis, evaluate the response rate (RR) and 6 month progression-free survival (PFS-6) of patients with microsatellite instability (MSI) and recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab.
Secondary Objectives
* Evaluate the safety and tolerability of epacadostat in combination with pembrolizumab.
* Evaluate the overall survival (OS) of patients with recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab as measured by modified RECIST v1.1.
* In a subset analysis, evaluate the overall survival (OS) of patients with microsatellite instability (MSI) and recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab.
* Evaluate the response rate (RR) and 6 month progression-free survival (PFS-6) of patients with recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab as measured by modified RECIST v1.1
* In a subset analysis, evaluate the response rate (RR) and 6 month progression-free survival (PFS-6) of patients with microsatellite instability (MSI) and recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab.
Secondary Objectives
* Evaluate the safety and tolerability of epacadostat in combination with pembrolizumab.
* Evaluate the overall survival (OS) of patients with recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab as measured by modified RECIST v1.1.
* In a subset analysis, evaluate the overall survival (OS) of patients with microsatellite instability (MSI) and recurrent or metastatic endometrial carcinoma when treated with epacadostat in combination with pembrolizumab.
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?:
None
Is an FDA AA801 Violation?: