A Randomized Double-Blind Phase III Study of Ipilimumab Administeredat 3 mg/kg vs at 10 mg/kg in Subjects with Previously Treated orUntreated Unresectable or Metastatic Melanoma.

Phase 1

• Conditions: Melanoma; MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004029-28-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-21
• Study Completion: 2017-08-17
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 831

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: 0
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: 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 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: Dopo che si sono verificati 540 eventi di decesso (analisi ad interim dopo che si sono verificati 360 eventi di decesso).

Secondary Outcome Measures

Name	Time	Method
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).