EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma — EPOCH  

Uterine Carcinosarcoma Clinical Trial

Official title: The EPOCH Study: Phase II Open Labelled Study Investigating the Use of Single Agent Eribulin and Eribulin in Combination With Pembrolizumab in Relapsed Tubo-ovarian or Uterine Carcinosarcoma

Status Recruiting

Clinical Trial Summary

The EPOCH study population is patients with tubo-ovarian carcinosarcoma or uterine carcinosarcoma with evidence of recurrence or progression.

The study aims to determine the activity of eribulin as a single agent and the combination of eribulin and pembrolizumab as measured by clinical benefit rate (CBR) at 12 weeks.

Additionally, the study aims to establish whether high mobility group A2 (HMGA2) protein expression is a good functional biomarker to predict response to eribulin and pembrolizumab.

Clinical Trial Description

EPOCH (Eribulin and Pembrolizumab in Tubo-Ovarian and Uterine Carcinosarcoma) is an international clinical trial, which aims to improve outcomes in people with the rare and highly lethal Ovarian Carcinosarcoma (OCS) or Uterine Carcinosarcoma (UCS) malignancies.

The underlying study rationale is based on robust preclinical evidence that demonstrated that eribulin, a microtubule inhibitor, can reprogram the tumour microenvironment, reversing epithelial mesenchymal transition (EMT) in these mesenchymal cancers, and potentiate the response to immune checkpoint blockade.

In addition, expression of HMGA2, a high mobility group protein has been associated with activation of EMT process and may be a predictive biomarker of eribulin-responsive cancers. This study is aimed at translating these laboratory findings to the clinic and treat patients with recurrent OCS and UCS with eribulin and the immune checkpoint inhibitor pembrolizumab, which targets and blocks the programmed cell death receptor 1 (PD-1). ;

Related Conditions & MeSH terms

• Carcinosarcoma
• Mixed Tumor, Mullerian
• Ovarian Carcinosarcoma
• Uterine Carcinosarcoma
• Uterine Neoplasms

• NCT number: NCT05619913
• Study type: Interventional
• Source: Australia New Zealand Gynaecological Oncology Group
• Contact: Clare Scott, AM MB BS PhD
• Phone: +61 3 9345 2350
• Email: scottc@wehi.edu.au
• Status: Recruiting
• Phase: Phase 2
• Start date: May 22, 2023
• Completion date: December 2026