What side effects are associated with this type of intervention?

Eribulin, a microtubule dynamics inhibitor, commonly causes side effects such as neutropenia, peripheral neuropathy, fatigue, alopecia, and gastrointestinal symptoms like nausea and constipation. Pembrolizumab, a PD-1 immune checkpoint inhibitor, can lead to immune-related adverse events including colitis, hepatitis, pneumonitis, endocrinopathies, and skin reactions. Both treatments may also result in general symptoms like fatigue and decreased appetite.

What prior FDA approvals exist?

There are no specific FDA approvals for the treatment of ovarian carcinosarcoma using eribulin or pembrolizumab. However, eribulin has shown activity in other types of sarcomas, and pembrolizumab has been approved for various cancers, including those with high microsatellite instability or mismatch repair deficiency, which can sometimes be relevant in gynecologic cancers. The EPOCH trial is investigating the efficacy of these drugs specifically for ovarian carcinosarcoma, which may provide new insights and potential future approvals.

What other types of research exist?

Promising alternatives to Eribulin and Pembrolizumab for ovarian carcinosarcoma patients include the combination of carboplatin and paclitaxel with bevacizumab, followed by bevacizumab maintenance therapy. Additionally, the combination of lenvatinib and pembrolizumab has shown potential, although further study is warranted to confirm its efficacy in this specific patient population.

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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

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 more

Other study objectives

Duration of response

High mobility group A2 (HMGA2) protein expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3130

Do I qualify?Apply below to find out

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.