Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
- Conditions
- Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
- Interventions
- Biological: Ipilimumab
- Registration Number
- NCT01611558
- Lead Sponsor
- 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
- Detailed Description
Condition: Ovarian Cancer, Second line, Third line, or Fourth line
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm: Ipilimumab, 10 mg/kg Ipilimumab 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher 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
Name Time Method Best Overall Response Rate (BORR) 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.
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 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.
Trial Locations
- Locations (17)
AdventHealth Cancer Institute
🇺🇸Orlando, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, 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
Dana Farber Cancer Institute.
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Nassau
🇺🇸New York, New York, United States
The Charlotte-Mecklenburg Hospital Authority
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Peggy and Charles Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Winship Cancer Institute.
🇺🇸Atlanta, Georgia, United States
Magee-Womens Hospital Of Upmc
🇺🇸Pittsburgh, Pennsylvania, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Women'S Cancer Care
🇺🇸Covington, Louisiana, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC
🇺🇸Tulsa, Oklahoma, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States