A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
- Registration Number
- NCT00162123
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description First reinduction: Ipilimumab, 10 to 10 mg/kg Ipilimumab Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. First reinduction: Ipilimumab, 3 to 10 mg/kg Ipilimumab Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. Extended maintenance: Ipilimumab, 3 mg/kg Ipilimumab Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. First reinduction: Ipilimumab, 0.3 to 10 mg/kg Ipilimumab Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. Extended maintenance: Ipilimumab, 0.3 mg/kg Ipilimumab Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Extended maintenance: Ipilimumab, 10 mg Ipilimumab Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
- Primary Outcome Measures
Name Time Method 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 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. 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Surviving at 1, 1.5, and 2 Years From first dose of study drug in parent study to up to 2 years after reinduction Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
Overall Survival (OS) From first dose of study drug in parent study to death or date of last censoring. 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.
Number of Participants With On-study Immune-related Adverse Events (irAEs) 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 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.
Progression-free Survival (PFS) From day of first reinduction in current study to date of progression or death, whichever occurred first. 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.
Trial Locations
- Locations (19)
The Angeles Clinic & Research Inst.
🇺🇸Los Angeles, California, United States
University Of Chicago
🇺🇸Chicago, Illinois, United States
Indiana Oncology Hematology Consultants
🇺🇸Indianapolis, Indiana, United States
San Francisco Oncology Associates
🇺🇸San Francisco, California, United States
Local Institution
🇺🇦Dnepropetrovsk, Ukraine
University Of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Cancer Centers Of The Carolinas
🇺🇸Greenville, South Carolina, United States
Wilshire Oncology Medical Group Inc
🇺🇸Laverne, California, United States
Usc/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
St Joseph Oncology Inc
🇺🇸St Joseph, Missouri, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
The Christ Hospital Cancer Center Research
🇺🇸Cincinnati, Ohio, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Center For Oncology Research & Treatment, P.A.
🇺🇸Dallas, Texas, United States
Joe Arrington Cancer Research And Treatment Center
🇺🇸Lubbock, Texas, United States
University Of Washington Medical Center
🇺🇸Seattle, Washington, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States