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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05619913
Other study ID # ANZGOG 1828/2021
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 22, 2023
Est. completion date December 2026

Study information

Verified date November 2023
Source Australia New Zealand Gynaecological Oncology Group
Contact Clare Scott, AM MB BS PhD
Phone +61 3 9345 2350
Email scottc@wehi.edu.au
Is FDA regulated No
Health authority
Study type Interventional

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.


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).


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Study Design


Intervention

Drug:
Eribulin Mesylate
Eribulin mesilate is a first-in-class halichondrin B-based, microtubule dynamics inhibitor7. It inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Pembrolizumab
Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).

Locations

Country Name City State
Australia Monash Health Clayton Victoria
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Prince of Wales Hospital Randwick New South Wales
Canada Princess Margaret Hospital Toronto Ontario
United Kingdom Imperial College London London

Sponsors (3)

Lead Sponsor Collaborator
Australia New Zealand Gynaecological Oncology Group Eisai Inc., Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

Australia,  Canada,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Duration of response Duration of response represented in annotated swimmers plot Up to 4 years
Other High mobility group A2 (HMGA2) protein expression Evaluate HMGA2 expression as predictive biomarker for response benefit. Up to 4 years
Primary Clinical Benefit Rate (CBR) by RECIST v1.1 in combination therapy arm CBR defined as Partial Response (PR), Complete Response (CR) or Stable Disease (SD) by RECIST v1.1 in the combination therapy arm. 12 Weeks
Secondary Clinical Benefit Rate (CBR) by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in single agent therapy arm CBR defined as Partial Response, Complete Response or Stable Disease by RECIST v1.1 in the single agent therapy arm. 12 weeks
Secondary Objective Response Rate (ORR) in both the single agent eribulin and combination eribulin/pembrolizumab arms Objective Response Rate (CR and PR by RECIST v1.1) at 12 weeks in both the single agent eribulin and combination eribulin/pembrolizumab arms 12 weeks
Secondary Clinical Benefit Rate (CBR) by iRECIST (modified RECIST guidelines for use in cancer immunotherapy trials) Clinical Benefit Rate (CR and PR and SD) by irRECIST at 12 weeks in both the single agent eribulin and combination eribulin/pembrolizumab arms 12 weeks
Secondary Time to progression in the combination therapy arm Determine time to progression in the combination therapy arm Up to 3 years
Secondary Progression free survival (PFS) Determine progression free survival (PFS) Up to 4 years
Secondary Overall Survival (OS) Determine Overall Survival (OS) Up to 4 years
Secondary Adverse events Determine toxicity, frequency, and severity of Adverse Events (CTCAE V5.0) Up to 4 years
Secondary Health related Quality of Life using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for cancer patients (QLQ C30) Determine aspects of health-related quality of life using EORTC QLQ C30 Up to 4 years
Secondary Health related Quality of Life using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire module for Ovarian Cancer patients (OV28) Determine aspects of health-related quality of life using EORTC OV28 Up to 4 years
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