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

NCT ID: NCT01611558

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-21
• Study Completion Date: 2019-07-03

Brief Summary

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

Detailed Description

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

Conditions

Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm: Ipilimumab, 10 mg/kg

Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: BIOLOGICAL

Interventions

Ipilimumab

Intervention Type: BIOLOGICAL

Other Intervention Names

Yervoy; BMS-734016

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Yale University School Of Medicine

New Haven, Connecticut, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute.

Atlanta, Georgia, United States

Georgia Regents University

Augusta, Georgia, United States

Dr. Sudarshan K. Sharma, Ltd.

Hinsdale, Illinois, United States

Indiana University Health Melvin And Bren Simon Cancer Center

Indianapolis, Indiana, United States

Women'S Cancer Care

Covington, Louisiana, United States

Dana Farber Cancer Institute.

Boston, Massachusetts, United States

Memorial Sloan Kettering Nassau

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

The Charlotte-Mecklenburg Hospital Authority

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, United States

Magee-Womens Hospital Of Upmc

Pittsburgh, Pennsylvania, United States

Countries

United States

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

CA184-201

Identifier Type: -

Identifier Source: org_study_id