test

Phase II Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer

Conditions

Cancer

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

Primary Objective:
-To assess the incidence of grade 3 or higher drug related adverse event in the study population during the induction period of ipilimumab (Day 1 of treatment to Week 24).
Secondary Objective:
-To assess the best overall response rate (BORR) in the study population by mWHO, immune-related response criteria (irRC), and CA125 Rustin Criteria. [Rustin, GJ 1996; Gordon, JS 2003]


Participation Guidelines

Age:
18 Years and older
Gender:
Female

Eligibility Criteria

Inclusion Criteria:

  • All subjects must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Histologic documentation of the tumor is required via the pathology report from either original diagnosis or subsequent relapses.
  • All subjects must have received a platinum-taxane based chemotherapy regimen as their frontline therapy for ovarian carcinoma. Subjects may also have received subsequent platinum based regimens but cannot be refractory or resistant.
  • Subjects are allowed to receive, but are not required to receive, up to 3 additional lines of
    ovarian carcinoma therapy. A line of therapy is defined as a regimen used to treat initial
    disease (frontline) or following disease progression (second or subsequent line). A
    change in regimen for reasons of toxicity or maintenance in the absence of disease
    progression does not constitute a new line of therapy.
  • All subjects must have Eastern Cooperative Oncology Group (ECOG) performance status.
  • All subjects enrolled in this trial must be treated at the participating centers and be
    accessible for treatment and follow-up.
  • Women > 18 years of age.

Exclusion Criteria:

  • Subjects with a histologic diagnosis of borderline, low malignant potential epithelial carcinoma.
  • Subjects with complete response (CR) on the most recent ovarian carcinoma therapy for this study.
  • Known brain metastasis.
  • Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged systemic immunosuppressive (ie, steroids) treatment.
  • Subjects with a history of motor neuropathy considered of autoimmune origin (eg, Guillain-Barré syndrome).
  • Subjects with a history of toxic epidermal necrolysis (TEN).
  • Human Immunodeficiency Virus (HIV), active Hepatitis B, or active Hepatitis C infection, based on testing performed during the screening period of this study. In the event of a reactive HIV or anti-HCV antibody test, results of confirmatory testing must be awaited before treatment allocation.
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the
    understanding or rendering of informed consent or completing questionnaires.
  • Serious uncontrolled medical disorder that, in the opinion of the investigator, would
    impair the ability of the subject to receive study therapy.
Sponsor:
Bristol-Myers Squibb Company
Dates:
02/11/2013
Last Updated:
Study HIC#:
1207010549