NCT01515189CompletedPhase 3
A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma
Bristol-Myers Squibb101 sites in 11 countries831 target enrollmentStarted: February 17, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 831
- Locations
- 101
- Primary Endpoint
- Overall Survival (OS)
Study Overview
Brief Summary
The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unresectable Stage III or Stage IV melanoma
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- •Brain metastases with symptoms or requiring treatment
- •History of autoimmune disease
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Approximately 48 months (assessed up to February 2016)
OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.
Secondary Outcomes
- Progression Free Survival (PFS) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Duration of Response (DOR) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Duration of Stable Disease by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Best Overall Response Rate (BORR) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Disease Control Rate (DCR) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Rate of Overall Survival(Approximately 66 months)
- Overall Survival of Participants With Brain Metastases at Baseline(From date of randomization until 540 death events occurred (approximately 48 months))
Investigators
Study Sites (101)
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