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New treatment option for Ovarian Carcinosarcoma
Official title EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma
ClinicalTrials.gov ID: NCT05619913
What this study is testing
What is Eribulin Mesylate?
Eribulin Mesylate is an investigational medicine, being studied as a potential treatment for ovarian carcinosarcoma.
Also referred to as Halaven.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of written informed consent prior to any study specific procedures and the ability to comply with the protocol for the duration of the...
- Patients \> 18 years old who have a histologically confirmed tubo-ovarian carcinosarcoma or uterine carcinosarcoma with evidence of recurrence or...
- Must have Positron Emission Tomography (PET), Computerized Tomography CT, or Magnetic Resonance Imaging (MRI) -proven relapsed disease after...
- Must have at least one evaluable measurable lesion (other than the lesion that will be used for biopsy) using standard techniques according to the...
- 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...
You likely can't join if
- 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...
- Prior treatment with eribulin for any malignancy.
- Absence of a second disease site suitable for biopsy
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the first dose of the study intervention.
- Has active autoimmune disease (such as Systemic Lupus Erythematosus) that has required systemic treatment in the past 2 years (i.e., with use of...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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 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.
- 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...
- 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.
- 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...
- 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...
- 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%).
- 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...
- Willing to have blood samples collected for translational research
- Must not be pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a person of childbearing potential (POCBP). OR
- 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.
What rules you out
- 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...
- Prior treatment with eribulin for any malignancy.
- Absence of a second disease site suitable for biopsy
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the first dose of the study intervention.
- 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)...
- 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...
- 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...
- 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...
- Symptomatic or clinically significant inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- 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...
- 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...
- Has an active infection requiring systemic therapy.
- Has had an allogenic tissue/solid organ transplant.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: no testing for HIV is required unless mandated by local health authority.
- 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...
- Has a known additional active malignancy that is likely to interfere with assessment of response or tolerance to the study intervention.
- 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...
- Inability to attend or comply with treatment or follow-up scheduling.
The study team makes the final eligibility decision.
Where it's taking place
- Randwick, New South Wales, Australia
- Herston, Queensland, Australia
- Clayton, Victoria, Australia
- Melbourne, Victoria, Australia
- Toronto, Ontario, Canada
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Randwick, New South Wales, Australia; Herston, Queensland, Australia; Clayton, Victoria, Australia; Melbourne, Victoria, Australia; Toronto, Ontario, Canada; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.