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Microtubule Inhibitor
Eribulin + Pembrolizumab for Carcinosarcoma (EPOCH Trial)
Phase 2
Recruiting
Led By Clare Scott, AM MB BS PhD
Research Sponsored by Australia New Zealand Gynaecological Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Summary
This trial tests eribulin and pembrolizumab in patients with recurring or worsening tubo-ovarian or uterine carcinosarcoma. Eribulin disrupts cancer cell structure, making them easier to attack, while pembrolizumab helps the immune system fight cancer by removing a protective shield on the cells. Eribulin has shown activity in various cancers, including ovarian and soft-tissue sarcomas.
Who is the study for?
The EPOCH trial is for adults over 18 with tubo-ovarian or uterine carcinosarcoma that has come back or gotten worse after 1-2 rounds of chemo. They must have a tumor sample available, be willing to undergo biopsies, and not be pregnant or breastfeeding. Participants need good organ function, no severe allergies to pembrolizumab, no recent immunotherapy or eribulin treatment, and can't have certain autoimmune diseases or active infections.
What is being tested?
This study tests how well eribulin alone and combined with pembrolizumab work in treating recurrent carcinosarcomas by looking at the clinical benefit rate at 12 weeks. It also explores if HMGA2 protein levels predict response to these drugs.
What are the potential side effects?
Eribulin may cause fatigue, low white blood cell count leading to infection risk, numbness in hands/feet (neuropathy), nausea/vomiting; Pembrolizumab might lead to immune system-related side effects like inflammation in organs such as lungs (pneumonitis) or intestines (colitis), skin rash, hormone gland problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Benefit Rate (CBR) by RECIST v1.1 in combination therapy arm
Secondary study objectives
Adverse events
Clinical Benefit Rate (CBR) by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in single agent therapy arm
Clinical Benefit Rate (CBR) by iRECIST (modified RECIST guidelines for use in cancer immunotherapy trials)
+6 moreOther study objectives
Duration of response
High mobility group A2 (HMGA2) protein expression
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 - Combination eribulin and pembrolizumab armExperimental Treatment2 Interventions
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.
Group II: Arm 1 - Single agent eribulin armExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin Mesylate
2014
Completed Phase 4
~3420
Pembrolizumab
2017
Completed Phase 2
~2070
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Eribulin is a microtubule dynamics inhibitor that disrupts the growth phase of microtubules, causing cell cycle arrest and cell death, which is crucial for targeting rapidly dividing cancer cells in ovarian carcinosarcoma. Pembrolizumab is a PD-1 immune checkpoint inhibitor that blocks the PD-1 pathway, enhancing the immune system's ability to detect and destroy cancer cells.
This combination of directly inhibiting cancer cell division and boosting immune response offers a comprehensive approach to treating ovarian carcinosarcoma, addressing both tumor growth and immune evasion.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,953 Total Patients Enrolled
Australia New Zealand Gynaecological Oncology GroupLead Sponsor
13 Previous Clinical Trials
4,402 Total Patients Enrolled
Eisai Inc.Industry Sponsor
518 Previous Clinical Trials
159,307 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms or diagnosed with severe inflammatory bowel disease.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have been treated with eribulin for cancer before.I have not received a live vaccine in the last 30 days.I have another active cancer that could affect the study results.I am willing to have a biopsy for my condition.I am currently being treated for an infection.I had radiotherapy less than 2 weeks before starting the study treatment.I can attend all treatments and follow-up appointments.My organs are functioning well.I have or had lung inflammation that needed steroids.I have been diagnosed with HIV.I am over 18 and have a confirmed diagnosis of tubo-ovarian or uterine carcinosarcoma with at least 5% sarcoma.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have a history of Hepatitis B or active Hepatitis C.I have a tumor sample with more than 30% cancer cells from surgery.I have previously been treated with immunotherapy targeting specific cancer pathways.My cancer returned after 1-2 chemotherapy treatments, confirmed by PET, CT, or MRI.I do not have a second site of disease that can be biopsied.I have an autoimmune disease treated with medication in the last 2 years.I have a tumor that can be measured, not counting the one for biopsy.I have received an organ or tissue transplant from another person.I have a brain tumor or cancer spread to the brain but have been stable for over a month after treatment.I am fully active or restricted in physically strenuous activity but can do light work.My biological samples were taken within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - Single agent eribulin arm
- Group 2: Arm 2 - Combination eribulin and pembrolizumab arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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