Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer

Study Overview
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Brief Summary
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EXCYTE-1 is a multicentre, prospective observational study to investigate the relationship between ex vivo drug response (EVDR), measured in ovarian tumour-derived samples using high content imaging, and actual patient clinical response. Patients with newly diagnosed or relapsed/refractory epithelial ovarian carcinoma, that present with malignant effusions (ascites or pleural effusions), will be enrolled in the study before starting their initial or next treatment line. Enrolled patients will be asked to provide ascites, peripheral blood and fresh tumour tissue if available. Samples will be shipped to the sponsor laboratory and their response to standard of care drugs evaluated ex vivo. Participants will: provide samples during routine clinical procedures agree that data about their medical history, diagnosis and health status at the following timepoints are collected: at signature of the consent form, at the time samples are provided, at start of the therapy, upon completion of the therapy, regularly after completion of the therapy

Official Title
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Observational Analysis of the Association of Drug Activity Measured in Viable Tumour Tissues ex Vivo and Clinical Response in Ovarian Cancer: A Basic Research Study

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Other: Biological sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age 18 years Signed informed consent form Confirmed diagnosis of ovarian cancer except low grade serous, clear cell and mucinous histology Where patients are treatment naïve, patients need to have disease stage FIGO (International Federation of Gynecology and Obstetrics) III or FIGO IV. Patient is expected to receive primary chemotherapy/maintenance after initial surgical debulking or a further line of systemic therapy in the relapsed setting according to treatment guidelines Feasibility of collecting malignant ascites and/or pleural effusion during either primary debulking surgery or a routine drainage procedure prior to initiation of the first or next line of systemic therapy ECOG (Eastern Cooperative Oncology Group) stage 0-2 Exclusion Criteria: Previously study participation Known or suspected HIV or active Hepatitis B and/or C infection or active COVID-19 infection Anticancer treatment or radiation therapy of the region which is to be drained or biopsied within the last 4 weeks Patient unfit or not willing to receive any further systemic treatment Patient is treated with therapeutics not tested in the assay - with the exception of anti-VEGF (Vascular endothelial growth factor) therapy Known pregnancy Sample quality criteria are not met (at least 250ml of ascites available, no signes of bacterial superinfection, no additives, at least 1% EpCAM (Epithelial Cell Adhesion Molecule) positive cells, viability at least 60%)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 125 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed<br>Newly diagnosed ovarian carcinoma patients presenting with ascites and/or pleural effusions before start of their initial therapy. | Other: Biological sample collection<br>* Collection of ascites, blood and fresh tumour tissues (if available)<br>|
| Relapsed/refractory<br>Relapsed/refractory (r/r) ovarian carcinoma patients presenting with ascites before start of their next therapy line (for r/r patients). | Other: Biological sample collection<br>* Collection of ascites, blood and fresh tumour tissues (if available)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome | EVDR will be compared to the clinical outcome, determined based on local practice | From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Percentage of ascites samples meeting inclusion and exclusion criteria that meet the quality criteria as per Exscientia SOPs (Standard Operating Procedures). | From study start to study end (up to 45 month). | 
| Prognostic value of EVDR of ascites samples in PFS (Progression-free survival) prediction | False positive and false negative rate in PFS prediction at 6 and 12 month | From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first. | 
| Biomarker impact on EVDR and its prognostic value | Hazard rate associated with established biomarkers and interaction between these markers and EVDR outcome | From study start to study end (up to 45 month). |