Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer

Condition: Ovarian Cancer, Second line, Third line, or Fourth line

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.