Epithelial Ovarian Cancer, Ovarian Cancer
Conditions
Keywords
ovarian cancer, catumaxomab, phase II, intraoperative, adjuvant, trifunctional antibody
Brief summary
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
Detailed description
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.
Interventions
DRUGCatumaxomab
10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
Sponsors
Neovii Biotech
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed and dated informed consent form before any protocol-specific screening procedures * patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV) * Karnofsky index \> or equal 70 * female at an age of 18 years or older * negative pregnancy test
Exclusion criteria
* exposure to prior cancer therapy specific for ovarian cancer * previos treatment with non-humanized mouse or rat monoclonal antibodies * known / suspected hypersensitivity to catumaxomab or similar antibodies * second malignangcy within the last 5 years * presence of constant immunosuppressive therapy * presence of symptomatic heart failure or occlusive arterial diseases * inadequate renal or hepatic function * presence of any acute or chronic systemic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of all specific postoperative complications newly observed during a period of 30 days after surgery | 30 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| safety and efficacy endpoints | EOS is on day 30, post study period additional 23 months |
Countries
Austria, Germany
Outcome results
None listed