Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy

Neovii Biotech47 enrolled

Overview

The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.

A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 4 months (includes the baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months follow-up), with post-study follow-up every 3 months for 2 years. Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM) on tumor cells and CD3 (cluster of differentiation 3) 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

catumaxomabDRUG

Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed and dated informed consent form before any protocol-specific screening procedures * Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stage IIb - IV * Optimal or sub-optimal cytoreductive surgery * Clinical complete response to platinum and taxane-based therapy consisting of at least four cycles, based on computed tomography (CT) scan and a CA-125 (cancer antigen 125) level below 35 U/mL * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Last dose of platinum and taxane-based therapy completed within 6 weeks prior to the start of catumaxomab treatment * Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility) * Willingness of patients of childbearing potential to use an effective contraceptive method (i.e. oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion Exclusion Criteria: * Acute or chronic systemic infection * Exposure to chemotherapy, radiotherapy, immunotherapy or investigational anti-cancer therapy within 6 weeks of first dose of catumaxomab other than last regimen of platinum and taxane chemotherapy as outlined in protocol * Known human immunodeficiency virus (HIV) infection * Previous treatment with non-humanized murine (rat or mouse) monoclonal antibodies (mAb) * Inadequate renal function (creatinine \> 1.5 x upper limit of normal \[ULN\]) * Inadequate hepatic function: * Alanine aminotransferase (ALT) \> 2.5 x ULN or * Aspartate aminotransferase (AST) \> 2.5 x ULN or * Bilirubin \> 1.5 x ULN * Platelets \< 100,000 cells/mm\^3 * Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 * History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within the last 6 months * No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix if adequately treated * No history of brain metastases * Any further condition or disease that would, in the opinion of the Investigator, expose the patient to undue risk

Locations (12)

Arizona Cancer Center

Tucson, Arizona, United States

Stanford University of Obstetrics and Gynecology

Stanford, California, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Outcomes

Primary Outcomes

Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days

Time frame: 21 days

Secondary Outcomes

Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy

Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.

Time frame: 2 months

Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

Time frame: Baseline

Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)

Time frame: 2 years

Number of Participants Who Survived (Post-study at 24 Month Visit)

Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die

Time frame: 2 years

Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

Time frame: 3 months

Data from ClinicalTrials.gov

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