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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05619913
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT05619913
Ethics application status
Date submitted
26/10/2022
Date registered
17/11/2022
Date last updated
8/02/2024
Titles & IDs
Public title
EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma
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Scientific 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
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Secondary ID [1]
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ANZGOG 1828/2021
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Universal Trial Number (UTN)
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Trial acronym
EPOCH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Carcinosarcoma
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Uterine Carcinosarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Eribulin Mesylate
Treatment: Drugs - Pembrolizumab
Experimental: Arm 1 - Single agent eribulin arm - Eribulin until progression of disease (PD) as defined by RECIST v1.1, unacceptable toxicity or physician/patient discretion or choice to cease treatment.
Patients who progress on the single agent eribulin arm may receive combination eribulin and pembrolizumab.
Experimental: Arm 2 - Combination eribulin and pembrolizumab arm - Eribulin for a maximum of 6 cycles. Pembrolizumab until PD or a maximum of 35 cycles (including the 6 cycles where it is administered in combination with eribulin) or until unacceptable toxicity or physician/patient discretion or choice to cease treatment.
Treatment: Drugs: 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.
Treatment: Drugs: 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).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Benefit Rate (CBR) by RECIST v1.1 in combination therapy arm
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Assessment method [1]
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CBR defined as Partial Response (PR), Complete Response (CR) or Stable Disease (SD) by RECIST v1.1 in the combination therapy arm.
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Timepoint [1]
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12 Weeks
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Secondary outcome [1]
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Clinical Benefit Rate (CBR) by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in single agent therapy arm
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Assessment method [1]
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CBR defined as Partial Response, Complete Response or Stable Disease by RECIST v1.1 in the single agent therapy arm.
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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Objective Response Rate (ORR) in both the single agent eribulin and combination eribulin/pembrolizumab arms
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Assessment method [2]
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Objective Response Rate (CR and PR by RECIST v1.1) at 12 weeks in both the single agent eribulin and combination eribulin/pembrolizumab arms
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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Clinical Benefit Rate (CBR) by iRECIST (modified RECIST guidelines for use in cancer immunotherapy trials)
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Assessment method [3]
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Clinical Benefit Rate (CR and PR and SD) by irRECIST at 12 weeks in both the single agent eribulin and combination eribulin/pembrolizumab arms
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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Time to progression in the combination therapy arm
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Assessment method [4]
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Determine time to progression in the combination therapy arm
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Progression free survival (PFS)
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Assessment method [5]
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Determine progression free survival (PFS)
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Timepoint [5]
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Up to 4 years
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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Determine Overall Survival (OS)
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Timepoint [6]
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Up to 4 years
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Secondary outcome [7]
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Adverse events
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Assessment method [7]
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Determine toxicity, frequency, and severity of Adverse Events (CTCAE V5.0)
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Timepoint [7]
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Up to 4 years
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Secondary outcome [8]
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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)
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Assessment method [8]
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Determine aspects of health-related quality of life using EORTC QLQ C30
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Timepoint [8]
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Up to 4 years
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Secondary outcome [9]
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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)
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Assessment method [9]
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Determine aspects of health-related quality of life using EORTC OV28
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Timepoint [9]
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Up to 4 years
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Eligibility
Key inclusion criteria
1. Provision of written informed consent prior to any study specific procedures and the
ability to comply with the protocol for the duration of the study, including
undergoing treatment and scheduled visits and examinations.
2. Patients > 18 years old who have a histologically confirmed tubo-ovarian
carcinosarcoma or uterine carcinosarcoma with evidence of recurrence or progression.
The component of sarcoma in the diagnostic pathology sample must be equal to or > 5%
of tumour.
3. Must have Positron Emission Tomography (PET), Computerized Tomography CT, or Magnetic
Resonance Imaging (MRI) -proven relapsed disease after completion of at least one line
and not more than two lines of chemotherapy.
4. Must have at least one evaluable measurable lesion (other than the lesion that will be
used for biopsy) using standard techniques according to the Response Evaluation
Criteria in Solid Tumours (RECIST v1.1) guidelines (Appendix 1).
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
(Appendix 5). Evaluation of ECOG is to be performed within 28 days prior to the first
dose of the study intervention.
6. Have adequate organ function as defined below (refer also Appendix 6).
- Absolute neutrophil count (ANC) =1.5 x 109/L
- Platelets =100 x 109/L
- Haemoglobin (Hb) =90 g/L or =5.6 mmol/L (criteria must be met without
erythropoietin dependency and without packed red blood cell (pRBC) transfusion
within last 2 weeks).
- Creatinine = 1.5 x Upper Limit Normal (ULN); OR Creatinine Clearance (CrCl) = 30
mL/min (calculated per institutional standard) for participants with creatinine
levels >1.5 ULN (glomerular filtration rate, GFR, can also be used in place of
creatinine or CrCl). (Patients with moderate renal impairment (CrCl 30-49ml/min)
will receive a 25% reduced dose of eribulin).
- Total bilirubin =1.5 ×ULN OR direct bilirubin =ULN for participants with total
bilirubin levels >1.5 × ULN
- Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) =2.5 × ULN (=5 × ULN for participants with liver
metastases)
- International normalized ratio (INR) OR prothrombin time (PT), Activated partial
thromboplastin time (aPTT) =1.5 × ULN unless participant is receiving
anticoagulant therapy as long as PT or aPTT is within therapeutic range of
intended use of anticoagulants Biological specimens must be collected within 28
days prior to the first dose of the study intervention (within 7 days, where
indicated in the SoA).
7. Available formalin fixed, paraffin embedded (FFPE) tumour sample from the primary
cancer and/or metastatic tumour from the up-front or secondary debulking surgery with
adequate neoplastic cell content (>30%).
8. Must have disease amenable to biopsy and must be willing to undergo a paired biopsy
for additional correlative analyses (the first biopsy to be performed within 28 days
prior to the start of the study intervention and the second biopsy in the five-day
window prior to Cycle 2 (post Cycle 1)). For patients that experience progression of
their disease whilst on study, separate patient consent will be sought for additional
biopsies of their tumour for research.
9. Willing to have blood samples collected for translational research
10. Must not be pregnant, not breastfeeding, and at least one of the following conditions
applies:
1. Not a person of childbearing potential (POCBP). OR
2. A POCBP who agrees to follow the contraceptive guidance during the treatment
period and for at least 4 months (120 days) after the last dose of the study
treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior line of treatment involving immunotherapy with an anti-PD-1, anti-PD-L1, or anti
PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell
receptor. This criteria is applicable for both intervention arms as patients may
cross-over from the non-immunotherapy arm during their study participation.
2. Prior treatment with eribulin for any malignancy.
3. Absence of a second disease site suitable for biopsy
4. Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks prior to the first dose of the study intervention.
5. Has active autoimmune disease (such as Systemic Lupus Erythematosus) that has required
systemic treatment in the past 2 years (i.e., with use of disease modifying agents,
corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
6. A POCBP who has a positive urine pregnancy test within 7 days prior to the first dose
of the study intervention (see Appendix 7). If the urine pregnancy test is positive or
cannot be confirmed as negative, a serum pregnancy test will be required.
7. Has received prior radiotherapy within 2 weeks of the start of the study intervention.
Patients must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted
for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system
disease.
8. Known central nervous system malignancy or metastasis, including leptomeningeal
metastasis or carcinomatous meningitis, unless adequately treated and patients are
neurologically stable for at least one month prior to enrolment. Patients must be
either off corticosteroids or on stable or decreasing dose of < /=10 mg daily
prednisone (or equivalent) within 28 days prior to the first dose of the study
intervention. In the case of short-term use of systemic corticosteroids (less than 24
hours within 28 days) of greater than 10 mg daily of prednisone or an equivalent
corticosteroid, the required washout period prior to starting the first dose of the
study intervention is 7 days. Anticonvulsants are allowed to be continued except for
those which interfere with the study interventions or are associated with liver
toxicity. However, patients receiving anticonvulsants must be discussed with Study
Chair or Acting Chair of Trial Management Committee (TMC) prior to their enrolment to
the study.
9. Symptomatic or clinically significant inflammatory bowel disease (Crohn's disease or
ulcerative colitis).
10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of the study
intervention.
11. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the
first dose of the study intervention. Live vaccine or live-attenuated vaccine cannot
be administered during treatment with the study intervention and for 30 days post
discontinuation of the study intervention. Administration of killed vaccines is
allowed.
12. Has an active infection requiring systemic therapy.
13. Has had an allogenic tissue/solid organ transplant.
14. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
15. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
16. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: no testing
for HIV is required unless mandated by local health authority.
17. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA > 25 international
units/mL is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is
required unless mandated by local health authority.
18. Has a known additional active malignancy that is likely to interfere with assessment
of response or tolerance to the study intervention.
19. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the patients'
participation for the full duration of the study, or is not in the best interest of
the patient to participate, in the opinion of the treating Investigator.
20. Inability to attend or comply with treatment or follow-up scheduling.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [3]
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Monash Health - Clayton
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment postcode(s) [2]
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- Herston
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Recruitment postcode(s) [3]
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- Clayton
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Recruitment postcode(s) [4]
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8006 - Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Country [2]
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United Kingdom
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State/province [2]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australia New Zealand Gynaecological Oncology Group
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Eisai Inc.
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Merck Sharp & Dohme LLC
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Address [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05619913
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clare Scott, AM MB BS PhD
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Clare Scott, AM MB BS PhD
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Address
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Country
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Phone
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+61 3 9345 2350
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05619913
Additional trial details provided through ANZCTR
Accrual to date
4
Recruiting in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1]
156
Peter MacCallum Cancer Centre
Recruitment hospital [2]
158
Royal Brisbane & Womens Hospital
Recruitment hospital [3]
159
Prince of Wales Hospital
Recruitment hospital [4]
160
Monash Medical Centre - Clayton campus
Recruitment postcode(s) [1]
156
3000
Recruitment postcode(s) [2]
157
3175
Recruitment postcode(s) [3]
158
4029
Recruitment postcode(s) [4]
159
2031
Recruitment postcode(s) [5]
160
3168
Funding & Sponsors
Primary sponsor
Other Collaborative groups
Primary sponsor name
Australia New Zealand Gynaecological Oncology Group
Primary sponsor address
Level 6, Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
64
PETER MACCALLUM CANCER CENTRE HUMAN RESEARCH ETHICS COMMITTEE
Address [1]
64
305 Grattan Street Melbourne Victoria 3000 Australia
Country [1]
64
Australia
Date submitted for ethics approval [1]
64
Approval date [1]
64
02/10/2023
Ethics approval number [1]
64
Public notes
Contacts
Principal investigator
Title
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Prof
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Name
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Clare Scott
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Address
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Country
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Australia
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Phone
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+61 3 9345 2350
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Fax
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Email
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[email protected]
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Contact person for public queries
Title
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Mr
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Name
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John Andrews
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Address
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Country
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Australia
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Phone
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+61 2 8071 4881
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Fax
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Email
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[email protected]
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Contact person for scientific queries
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Name
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