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Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

NCT01515189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 831

Last updated 2019-07-31

Study results available
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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

Conditions

Interventions

BIOLOGICAL

Ipilimumab

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-17
Primary Completion
2016-02-06
Completion
2017-08-17

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515189 on ClinicalTrials.gov