To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
Condition: Ovarian Cancer, Second line, Third line, or Fourth line
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Yale University School Of Medicine
New Haven, Connecticut, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
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.
Time frame: Day 1, first dose, to within 90 days of last dose in Induction Phase
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.
Time frame: From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)
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.
Time frame: From first dose to within 90 days of last study dose
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