Clinical trial NCT06068738: Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epithelial Ovarian Cancer
Lead sponsor: Exscientia AI Limited
Sponsor class: INDUSTRY
Collaborators: name: AGO Research GmbH
First posted: 2023-10-05
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll newly diagnosed patients with advanced ovarian cancer (FIGO III and FIGO IV) where ascites can be collected during a routine primary debulking surgery, or patients with relapsed (1st, 2nd and 3rd relapse) ovarian cancer scheduled to undergo routine drainage of malignant ascites.

Brief 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


Eligibility criteria: 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%)

Primary outcomes:
measure: Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome
timeFrame: From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month.
Secondary outcomes:
measure: Technical success rate
timeFrame: From study start to study end (up to 45 month).
measure: Prognostic value of EVDR of ascites samples in PFS (Progression-free survival) prediction
timeFrame: From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first.
measure: Biomarker impact on EVDR and its prognostic value
timeFrame: From study start to study end (up to 45 month).
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe
state: Upper Austria
city: Vienna
country: Austria
facility: Med. Universität Wien - Universitätsklinik für Frauenheilkunde
city: Essen
country: Germany
facility: Evang. Kliniken Essen-Mitte gGmbH
state: North Rhine-Westphalia
city: Tübingen
country: Germany
facility: Department für Frauengesundheit/Universitäts-Frauenklinik Tübingen
Study officials:
affiliation: Exscientia GmbH
name: Nikolaus Krall, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.