Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer

Study Overview
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Brief Summary
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Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

Detailed Description
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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.

Official Title
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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

Conditions
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Ovarian Cancer, Epithelial Ovarian Cancer

Intervention / Treatment
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* Drug: Catumaxomab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Catumaxomab<br>* 10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of all specific postoperative complications newly observed during a period of 30 days after surgery |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and efficacy endpoints |  | EOS is on day 30, post study period additional 23 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, catumaxomab, phase II, intraoperative, adjuvant, trifunctional antibody