Overview

This trial is active, not recruiting.

Condition melanoma
Treatment ipilimumab
Phase phase 3
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date February 2012
End date February 2016
Trial size 700 participants
Trial identifier NCT01515189, 2011-004029-28, CA184-169

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
ipilimumab Yervoy
(Experimental)
Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
ipilimumab Yervoy

Primary Outcomes

Measure
Overall survival (OS)
time frame: After 540 death events have occurred (approximately 44 months after the first subject is randomized)

Secondary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Approximately 44 months after the first subject is randomized
Best Overall Response Rate (BORR)
time frame: Approximately 44 months after the first subject is randomized
Disease Control Rate (DCR)
time frame: Approximately 44 months after the first subject is randomized
Duration of Response
time frame: Approximately 44 months after the first subject is randomized
Duration of Stable Disease
time frame: Approximately 44 months after the first subject is randomized

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.