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



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/9/2017
Start Date:August 21, 2012
End Date:July 8, 2019

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A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects

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

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.
We found this trial at
17
sites
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Atlanta, Georgia 30322
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Boston, Massachusetts 02115
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Charlotte, North Carolina 28203
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Covington, Louisiana 70433
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hinsdale, Illinois 60521
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73104
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Orlando, Florida 32804
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Tampa, Florida 33612
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The Bronx, New York 10467
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