Multicenter, Single-arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer
An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage
design. The surgical procedure on Day 0 will be performed according to AGO State of the Art,
followed by one intraoperative and four postoperative intraperitoneal administrations of
catumaxomab within 16 days. The Discharge Visit will be performed when the patient is
leaving the hospital but not earlier than 1 day after the last infustion, followed by the
End of Study Visit on Day 30.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells.
Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new
antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages,
dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to
preclinical data, trifunctional antibodies activate these different immune effector cells,
which can trigger a complex anti-tumor immune response.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the rate of all specific postoperative complications newly observed during a period of 30 days after surgery
30 days after surgery
Jahlid Sehouli, MD
Klinikum Charité, 13355 Berlin