Actively Recruiting
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
Led by Australia New Zealand Gynaecological Oncology Group · Updated on 2025-02-04
30
Participants Needed
6
Research Sites
91 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
Researchers are studying patients with tubo-ovarian or uterine carcinosarcoma who have experienced recurrence or progression of their disease. The study aims to assess the activity of eribulin alone and in combination with pembrolizumab by measuring clinical benefit rate at 12 weeks. It also evaluates whether the protein HMGA2 can help predict patient response to these treatments. This is a phase II international clinical trial focused on these rare and aggressive cancers. Participants will receive either eribulin alone until their disease progresses, unacceptable side effects occur, or they choose to stop, or a combination of eribulin and pembrolizumab. Patients who progress on eribulin alone may later receive the combination treatment. Pembrolizumab is given for up to 35 cycles, including the combination period, while eribulin is limited to six cycles in the combination group. Treatments target the cancer cells and the immune system to explore potential benefits. During the study, patients will undergo imaging scans to monitor tumor response, biopsies before and after treatment cycles to study tissue changes, and blood samples for research. Researchers will evaluate clinical benefit, response rates, progression times, survival, side effects, and quality of life over several years. Follow-up assessments will continue for up to four years to understand long-term effects and safety.
CONDITIONS
Brief Title
EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and agree to follow study procedures
- Age 18 years or older
- Histologically confirmed tubo-ovarian or uterine carcinosarcoma with recurrence or progression
- Sarcoma component must be 5% or more of tumor
- Relapsed disease proven by PET, CT, or MRI after 1-2 chemotherapy lines
- At least one measurable lesion by RECIST v1.1
- ECOG performance status 0 or 1
- Adequate organ function as defined by blood counts, liver, and kidney tests
- Available tumor sample with over 30% cancer cells
- Disease suitable for biopsy and willing to undergo paired biopsies
- 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 treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immunotherapy
- Prior treatment with eribulin for any cancer
- No second disease site available for biopsy
- Received systemic anti-cancer therapy within 4 weeks prior to study start
- Active autoimmune disease needing systemic treatment in past 2 years
- Positive pregnancy test or breastfeeding
- Radiotherapy within 2 weeks before study start without recovery
- Central nervous system malignancy or metastasis unless stable for 1 month
- Symptomatic or significant inflammatory bowel disease
- Immunodeficiency or high dose immunosuppressive therapy within 7 days
- Live vaccine within 30 days prior to study start or planned during study
- Active infection requiring systemic therapy
- History of allogenic tissue or organ transplant
- Severe hypersensitivity to pembrolizumab or its components
- History of pneumonitis or interstitial lung disease requiring steroids
- Known HIV, active Hepatitis B or C infection
- Other active malignancies interfering with study assessment
- Any condition or abnormality interfering with study participation
- Inability to comply with treatment or follow-up schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 cycles of pembrolizumab (including 6 cycles combined with eribulin) or until disease progression or discontinuation
Participants receive either single agent eribulin or a combination of eribulin and pembrolizumab. Treatment continues until disease progression, unacceptable toxicity, or participant/physician choice to stop. Those on single agent eribulin who progress may receive the combination treatment.
Repeated visits for treatment cycles as per protocol
Duration - Up to 4 years
Participants are monitored for disease progression, survival, adverse events, and quality of life outcomes after treatment ends.
Periodic follow-up visits as scheduled
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
J
John Andrews
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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