Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05619913
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-10-26
Brief Title:
EPOCH Eribulin and Pembrolizumab in OvarianUterine Carcinosarcoma
Sponsor:
Australia New Zealand Gynaecological Oncology Group
Organization:
Australia New Zealand Gynaecological Oncology Group
Study Overview
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
Status Verified Date:
2023-11
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:
EPOCH
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None