Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01611558
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01611558
Study Brief:
Protocol Section:
NCT01611558