The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time frame: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
Overall Survival (OS)
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
Time frame: From first dose of study drug in parent study to death or date of last censoring.
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
Time frame: From first dose of study drug in parent study to up to 2 years after reinduction
Number of Participants With On-study Immune-related Adverse Events (irAEs)
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
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University Of Arizona Cancer Center
Tucson, Arizona, United States
Wilshire Oncology Medical Group Inc
Laverne, California, United States
The Angeles Clinic & Research Inst.
Los Angeles, California, United States
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
San Francisco Oncology Associates
San Francisco, California, United States
Local Institution
To Come, Connecticut, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
University Of Chicago
Chicago, Illinois, United States
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States
St Joseph Oncology Inc
Saint Joseph, Missouri, United States
...and 48 more locations
Time frame: From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
Progression-free Survival (PFS)
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.
Time frame: From day of first reinduction in current study to date of progression or death, whichever occurred first.