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Clinical Trials/NCT00289640
NCT00289640
Completed
Phase 2

A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Bristol-Myers Squibb26 sites in 2 countries210 target enrollmentApril 2006
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ConditionsMelanoma
Interventionsipilimumab (MDX-010, BMS-734016)Ipilimumab
Drugsipilimumab (MDX-010, BMS-734016)Ipilimumab

Overview

Phase
Phase 2
Intervention
ipilimumab (MDX-010, BMS-734016)
Conditions
Melanoma
Sponsor
Bristol-Myers Squibb
Enrollment
210
Locations
26
Primary Endpoint
estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
July 2007
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Intervention: ipilimumab (MDX-010, BMS-734016)

2

Intervention: Ipilimumab

3

Intervention: Ipilimumab

Outcomes

Primary Outcomes

estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.

Secondary Outcomes

  • estimate progression free survival rate at Week 12 assessment and other timepoints
  • estimate disease control rate at various time points
  • estimate overall survival
  • estimate survival rate at one year
  • evaluate health-related quality of life
  • obtain pharmacokinetic samples for population PK analysis

Study Sites (26)

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