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

Phase 1

• Conditions: Melanoma; MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004029-28-HU
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-24
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>• To compare progression-free survival between doses of 3 mg/kg and 10 mg/kg by mWHO criteria<br>• To compare best overall response rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria<br>• To compare disease control rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria<br>• To evaluate duration of response and stable disease for the of 3 mg/kg and 10 mg/kg dose groups by mWHO criteria<br>• To evaluate the OS in each of the two dosing groups in the subset of subjects with brain metastases<br>;Primary end point(s): Overall Survival will be assessed;Timepoint(s) of evaluation of this end point: After 540 deaths events have occurred (interim analysis after 360 deaths have occured)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Progression Free Survival<br>- Best Overall Response Rate<br>- Disease Control Rate<br>- Duration of Response<br>- 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 )