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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01611558
Recruitment Status : Active, not recruiting
First Posted : June 5, 2012
Results First Posted : April 19, 2016
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line Biological: Ipilimumab Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Actual Study Start Date : August 21, 2012
Actual Primary Completion Date : November 3, 2014
Estimated Study Completion Date : July 8, 2019

Arm Intervention/treatment
Experimental: 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.
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016

Primary Outcome Measures :
  1. Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher [ Time Frame: Day 1, first dose, to within 90 days of last dose in Induction Phase ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.

Secondary Outcome Measures :
  1. Best Overall Response Rate (BORR) [ Time Frame: From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years) ]
    BORR is defined as the percentage of participants who received treatment and, at any time during the study, had a best response of complete response or partial response, as confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria for patients with cancer antigen 125 (CA125) levels elevated to twice the upper limit of normal at baseline, divided by the total number of evaluable participants in the arm.

  2. Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation [ Time Frame: From first dose to within 90 days of last study dose ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01611558

United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute.
Atlanta, Georgia, United States, 30308
Georgia Regents University
Augusta, Georgia, United States, 30912-3335
United States, Illinois
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois, United States, 60521
United States, Indiana
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Women'S Cancer Care
Covington, Louisiana, United States, 70433
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Montefiore Medical Center
The Bronx, New York, United States, 10461
United States, North Carolina
The Charlotte-Mecklenburg Hospital Authority
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Magee-Womens Hospital Of Upmc
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01611558     History of Changes
Other Study ID Numbers: CA184-201
First Posted: June 5, 2012    Key Record Dates
Results First Posted: April 19, 2016
Last Update Posted: November 7, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Second Primary
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs