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

Epithelial Ovarian Cancer Clinical Trial

— EXCYTE-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068738
• Other study ID #: AC2202
• Status: Recruiting
• Start date: April 14, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Exscientia AI Limited
• Contact: Sarah Himbert-Baudis
• Phone: +43 676 852 525
• Email: shimbertbaudis[@]exscientia.co.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 125 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Biological sample collection
Collection of ascites, blood and fresh tumour tissues (if available)

Locations

Country	Name	City	State
Austria	Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe	Linz	Upper Austria
Austria	Med. Universität Wien - Universitätsklinik für Frauenheilkunde	Vienna
Germany	Evang. Kliniken Essen-Mitte gGmbH	Essen	North Rhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Exscientia GmbH	AGO Research GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

Kornauth C, Pemovska T, Vladimer GI, Bayer G, Bergmann M, Eder S, Eichner R, Erl M, Esterbauer H, Exner R, Felsleitner-Hauer V, Forte M, Gaiger A, Geissler K, Greinix HT, Gstottner W, Hacker M, Hartmann BL, Hauswirth AW, Heinemann T, Heintel D, Hoda MA, Hopfinger G, Jaeger U, Kazianka L, Kenner L, Kiesewetter B, Krall N, Krajnik G, Kubicek S, Le T, Lubowitzki S, Mayerhoefer ME, Menschel E, Merkel O, Miura K, Mullauer L, Neumeister P, Noesslinger T, Ocko K, Ohler L, Panny M, Pichler A, Porpaczy E, Prager GW, Raderer M, Ristl R, Ruckser R, Salamon J, Schiefer AI, Schmolke AS, Schwarzinger I, Selzer E, Sillaber C, Skrabs C, Sperr WR, Srndic I, Thalhammer R, Valent P, van der Kouwe E, Vanura K, Vogt S, Waldstein C, Wolf D, Zielinski CC, Zojer N, Simonitsch-Klupp I, Superti-Furga G, Snijder B, Staber PB. Functional Precision Medicine Provides Clinical Benefit in Advanced Aggressive Hematologic Cancers and Identifies Exceptional Responders. Cancer Discov. 2022 Feb;12(2):372-387. doi: 10.1158/2159-8290.CD-21-0538. Epub 2021 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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.
Secondary	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).