NCT03310567

A Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma

A Phase 2 Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent/ Metastatic Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	Epacadostat + pembrolizumab	Each patient would be administered epacadostat orally twice a day and pembroluzimab by infusion once in a cycle of 21 days

Timeline

• Start date: 2018-09-01
• Primary completion: 2018-09-10
• Completion: 2018-09-10
• First posted: 2017-10-16
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study