Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT03310567
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.
Study:
NCT03310567
Study Brief:
Protocol Section:
NCT03310567