Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01611558|
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : April 19, 2016
Last Update Posted : July 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line||Biological: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Completion Date :||July 3, 2019|
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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01611558
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|