Phase 3 Trial in Subjects with Metastatic Melanoma Comparing 3 mg/kg Ipilimumab versus 10 mg/kg Ipilimumab

A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic Melanoma Revised Protocol 03 incorporating Protocol Amendment 11 + Pharmacogenetics Blood Sample Amendment- Site Specific (version 1.0 dated 10-Nov-11) + Biomarker Sub-Study Protocol amendment 06 version 1.0, dated 29-May-2012- Site-specific

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004029-28-DE

Enrollment

800

Registered

2011-12-22

Start date

2012-03-01

Completion date

Unknown

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma MedDRA version: 14.1 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864

Interventions

Product Name: IPILIMUMAB Product Code: BMS-734016 / MDX010 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IPILIMUMAB CAS Number: 477202-00-9 Current Sponsor code: BMS-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Unresectable Stage III or Stage IV melanoma • ECOG PS 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 544 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 256

Exclusion criteria

Exclusion criteria: • Brain metastases with symptoms or requiring treatment • History of automimmune disease

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to determine whether giving ipilimumab at a dose of 10 mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving ipilimumab at a dose of 3 mg/kg;Secondary Objective: Efficacy: • To compare progression-free survival between doses of 3 mg/kg and 10 mg/kg by mWHO criteria • To compare best overall response rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria • To compare disease control rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria • To evaluate duration of response and stable disease for the of 3 mg/kg and 10 mg/kg dose groups by mWHO criteria • To evaluate long term overall survival and overall survival rates in each of the two dosing groups on a yearly basis for up to 5 years after the last subject was randomized • To evaluate the OS in each of the two dosing groups in the subset of subjects with brain metastases ;Primary end point(s): Overall Survival will be assessed;Timepoint(s) of evaluation of this end point: After 540 deaths events have occurred	—

Measure

Time frame

Main Objective: The purpose of this study is to determine whether giving ipilimumab at a dose of 10 mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving ipilimumab at a dose of 3 mg/kg;Secondary Objective: Efficacy: • To compare progression-free survival between doses of 3 mg/kg and 10 mg/kg by mWHO criteria • To compare best overall response rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria • To compare disease control rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria • To evaluate duration of response and stable disease for the of 3 mg/kg and 10 mg/kg dose groups by mWHO criteria • To evaluate long term overall survival and overall survival rates in each of the two dosing groups on a yearly basis for up to 5 years after the last subject was randomized • To evaluate the OS in each of the two dosing groups in the subset of subjects with brain metastases ;Primary end point(s): Overall Survival will be assessed;Timepoint(s) of evaluation of this end point: After 540 deaths events have occurred

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Secondary

Measure	Time frame
Secondary end point(s): - Progression Free Survival - Best Overall Response Rate - Disease Control Rate - Duration of Response - Duration of Stable Disease;Timepoint(s) of evaluation of this end point: After 540 deaths have occurred (at the same time as the primary analysis )	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactEU Study Start-Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026