Actively Recruiting
EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma
Led by Australia New Zealand Gynaecological Oncology Group · Updated on 2025-02-04
30
Participants Needed
6
Research Sites
184 weeks
Total Duration
On this page
Sponsors
A
Australia New Zealand Gynaecological Oncology Group
Lead Sponsor
E
Eisai Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and can comply with study procedures
- Age over 18 years with confirmed tubo-ovarian or uterine carcinosarcoma showing recurrence or progression
- Have relapsed disease confirmed by PET, CT, or MRI after 1 to 2 chemotherapy lines
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function, including specific blood counts and kidney, liver function criteria
- Available tumor tissue sample with sufficient cancer cells
- Willingness to undergo biopsies before treatment and after first treatment cycle
- Willing to provide blood samples for research
- Not pregnant or breastfeeding and agree to contraception if of childbearing potential
You will not qualify if you...
- Previous immunotherapy targeting PD-1, PD-L1, PD-L2, or other T-cell receptors
- Prior treatment with eribulin
- No second biopsy site available
- Systemic anti-cancer therapy within 4 weeks before study start
- Active autoimmune disease requiring recent systemic treatment
- Positive pregnancy test or breastfeeding
- Radiotherapy within 2 weeks before study start without recovery
- Untreated or unstable brain metastases or central nervous system malignancy
- Significant inflammatory bowel disease
- Immunodeficiency or recent immunosuppressive therapy
- Recent live vaccine administration
- Active infection requiring treatment
- History of organ transplant
- Severe allergy to pembrolizumab or its components
- History or current pneumonitis or interstitial lung disease
- Known HIV, active Hepatitis B or C infection
- Other active cancers interfering with study
- Any condition or treatment interfering with study participation
- Inability to comply with treatment or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Prince of Wales Hospital
Randwick, New South Wales, Australia
Actively Recruiting
2
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Actively Recruiting
3
Monash Health
Clayton, Victoria, Australia
Actively Recruiting
4
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Actively Recruiting
5
Princess Margaret Hospital
Toronto, Ontario, Canada
Actively Recruiting
6
Imperial College London
London, United Kingdom
Not Yet Recruiting
Research Team
C
Clare Scott, AM MB BS PhD
CONTACT
J
John Andrews
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here