Back to resultsPhase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Primary Purpose
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
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.
Sites / Locations
- Yale University School Of Medicine
- AdventHealth Cancer Institute
- H. Lee Moffitt Cancer Center
- Winship Cancer Institute.
- Georgia Regents University
- Dr. Sudarshan K. Sharma, Ltd.
- Indiana University Health Melvin And Bren Simon Cancer Center
- Women'S Cancer Care
- Dana Farber Cancer Institute.
- Montefiore Medical Center
- Memorial Sloan Kettering Nassau
- The Charlotte-Mecklenburg Hospital Authority
- Duke University Medical Center
- MetroHealth Medical Center
- Peggy and Charles Stephenson Cancer Center
- Oklahoma Cancer Specialists and Research Institute, LLC
- Magee-Womens Hospital Of Upmc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm: Ipilimumab, 10 mg/kg
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
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
Best Overall Response Rate (BORR)
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01611558
Brief Title
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Official Title
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 21, 2012 (Actual)
Primary Completion Date
November 3, 2014 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm: Ipilimumab, 10 mg/kg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Primary Outcome Measure Information:
Title
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
Description
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.
Time Frame
Day 1, first dose, to within 90 days of last dose in Induction Phase
Secondary Outcome Measure Information:
Title
Best Overall Response Rate (BORR)
Description
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.
Time Frame
From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)
Title
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
Description
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.
Time Frame
From first dose to within 90 days of last study dose
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
AdventHealth Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3335
Country
United States
Facility Name
Dr. Sudarshan K. Sharma, Ltd.
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Indiana University Health Melvin And Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Women'S Cancer Care
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Dana Farber Cancer Institute.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Charlotte-Mecklenburg Hospital Authority
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Peggy and Charles Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Magee-Womens Hospital Of Upmc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
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