Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
Medarex
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00289640
First received: February 9, 2006
Last updated: February 27, 2010
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: ipilimumab (MDX-010, BMS-734016)
Drug: Ipilimumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 210
Study Start Date: April 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Experimental: 2 Drug: Ipilimumab
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Experimental: 3 Drug: Ipilimumab
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289640

  Show 62 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00289640     History of Changes
Other Study ID Numbers: CA184-022
Study First Received: February 9, 2006
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Stage III (unresectable)
Stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014