Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Condition: Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasms, Second Primary; Hypersensitivity
Intervention: Ipilimumab
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall
      response associated with ipilimumab treatment
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Key Inclusion Criteria

          -  Ovarian cancer that is not refractory or resistant to platinum-based therapy
             (refactory=progression while receiving any previous platinum regimen;
             resistant=progression within 6 months of any previous platinum regimen)

          -  Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian
             cancer

          -  An Eastern Cooperative Oncology Group performance status ≤1

          -  Up to 4 prior lines of therapy for ovarian cancer

          -  Two groups are eligible:

        Group 1. Women who have not met the criteria for progressive disease following their most
        recent chemotherapeutic regimen were required to have:

          -  Demonstrated partial response or stable disease following the most recent chemotherapy
             regimen

          -  Evaluable or measurable disease, detected by baseline computed tomography (CT) or
             magnetic resonance imaging (MRI) scan

          -  Received the last dose of their most recent chemotherapeutic regimen for ovarian
             cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women
             with disease progression while receiving or following the last dose of the most recent
             chemotherapeutic regimen were required to have:

          -  Measurable disease on a CT or MRI scan performed within 28 days of first dose of
             ipilimumab.

          -  Received the last dose of their most recent chemotherapeutic regimen for ovarian
             cancer at least 4 weeks prior to the first administration of ipilimumab.

        Key Exclusion Criteria

          -  Histologic diagnosis of borderline, low malignant potential epithelial carcinoma

          -  For Group 1, women with complete response on the most recent ovarian carcinomatherapy

          -  Presence of known brain metastases

          -  Second malignancy active within the past 5 years, with the exception of locally
             curable cancers that have no need for subsequent therapy

          -  Documented history of severe autoimmune or immune-mediated symptomatic disease
             requiring prolonged systemic immunosuppressive treatment

          -  History of motor neuropathy considered to be of autoimmune origin or the of grade 2 or
             higher peripheral neuropathy

          -  History of toxic epidermal necrolysis

          -  Prior therapies with immunosuppressive agents within the last 2 years (excluding
             low-dose corticosteroids) and prior therapies with cytotoxic drugs within 4 weeks

          -  Chronic use of systemic immunosuppressive drugs, ongoing use of immunotherapy or
             biologic therapy for the treatment of cancer, or prior use of ipilimumab or any
             immune-stimulating agent.