Suspended

An Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin

What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Adnexal Diseases

Until 80 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 2004

See protocol details

Summary

Principal SponsorUnither Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against cancer cells. The purpose of this research study is to determine if immunotherapy with oregovomab can create an immune response and enable the body to fight the disease and help ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer will be screened for study participation pre-surgery and, if eligible, will receive oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for about a year following chemotherapy. Patients who experience disease progression will be discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples collected to assess the immune response to oregovomab.

Official TitleAn Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin

NCT00086632

Principal SponsorUnither Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Until 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

7 inclusion criteria required to participate

A histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III - IV, expressing the tumor-associated antigen CA125 as measured by a serum CA125 level ≥ 35 U/mL and tumor tissue which has been demonstrated by immunohistochemical methods to express CA125. All patients must provide primary tumor (and lymph node and ascites samples, if available) samples for cellular immunology assays and characterization

A functional performance status of ≤2 on the ECOG scale

Are randomized into the study no more than eight (8) weeks postoperatively

Have an expected survival of at least 6 months

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13 exclusion criteria prevent from participating

Have received radiotherapy or chemotherapy

Have circumstances at the time of entry onto the protocol would not permit completion of study or require follow-up

Have other invasive malignancies, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy

Have significant cardiovascular abnormalities [uncontrolled hypertension, Congestive Heart Failure (CHF) New York Heart Association (NYHA) Classes II-IV, see Appendix C), uncontrolled angina, myocardial infarction within the past six months or uncontrolled arrhythmias]. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers