RecruitingPhase 2NCT05619913

EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma

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


Sponsor

Australia New Zealand Gynaecological Oncology Group

Enrollment

30 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eribulin Mesylate and a drug called Pembrolizumab for people with ovarian carcinosarcoma and uterine carcinosarcoma. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEribulin 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.

DRUGPembrolizumab

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(6)

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Princess Margaret Hospital

Toronto, Ontario, Canada

Imperial College London

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05619913


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