EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma

ConditionsOvarian Carcinosarcoma Uterine Carcinosarcoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorAustralia New Zealand Gynaecological Oncology Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

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 (Appendix 1).

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Eribulin Mesylate
Drug
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.
Pembrolizumab
Drug
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).

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Arm 1 - Single agent eribulin armExperimental treatment 1 intervention

Group B: Arm 2 - Combination eribulin and pembrolizumab armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Clinical Benefit Rate (CBR) by RECIST v1.1 in combination therapy arm

CBR defined as Partial Response (PR), Complete Response (CR) or Stable Disease (SD) by RECIST v1.1 in the combination therapy arm.

Time frame

12 Weeks

Secondary outcomes

Clinical Benefit Rate (CBR) by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in single agent therapy arm

CBR defined as Partial Response, Complete Response or Stable Disease by RECIST v1.1 in the single agent therapy arm.

Time frame

12 weeks

Objective Response Rate (ORR) in both the single agent eribulin and combination eribulin/pembrolizumab arms

Objective Response Rate (CR and PR by RECIST v1.1) at 12 weeks in both the single agent eribulin and combination eribulin/pembrolizumab arms

Time frame

12 weeks

Clinical Benefit Rate (CBR) by iRECIST (modified RECIST guidelines for use in cancer immunotherapy trials)

Clinical Benefit Rate (CR and PR and SD) by irRECIST at 12 weeks in both the single agent eribulin and combination eribulin/pembrolizumab arms

Time frame

12 weeks

Time to progression in the combination therapy arm

Determine time to progression in the combination therapy arm

Time frame

Up to 3 years

Other outcomes

Duration of response

Duration of response represented in annotated swimmers plot

Time frame

Up to 4 years

High mobility group A2 (HMGA2) protein expression

Evaluate HMGA2 expression as predictive biomarker for response benefit.

Time frame

Up to 4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Australia New Zealand Gynaecological Oncology Group

Lead sponsor

Eisai Inc.

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov

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