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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 will study how well a drug and a drug combo work to treat a specific type of cancer and if a protein can predict how the drugs will work.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Benefit Rate (CBR) by RECIST v1.1 in combination therapy arm
Secondary outcome measures
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 outcome measures
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
~2010

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
3,919 Previous Clinical Trials
5,068,233 Total Patients Enrolled
Australia New Zealand Gynaecological Oncology GroupLead Sponsor
13 Previous Clinical Trials
4,402 Total Patients Enrolled
Eisai Inc.Industry Sponsor
517 Previous Clinical Trials
158,902 Total Patients Enrolled

Media Library

Eribulin Mesylate (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05619913 — Phase 2
Ovarian Carcinosarcoma Research Study Groups: Arm 1 - Single agent eribulin arm, Arm 2 - Combination eribulin and pembrolizumab arm
Ovarian Carcinosarcoma Clinical Trial 2023: Eribulin Mesylate Highlights & Side Effects. Trial Name: NCT05619913 — Phase 2
Eribulin Mesylate (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05619913 — Phase 2
~7 spots leftby Dec 2024