A Single Arm Study of Ipilimumab 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:
NCT00289627
First received: February 9, 2006
Last updated: September 23, 2010
Last verified: June 2010
  Purpose

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) 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:
  • Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.

Secondary Outcome Measures:
  • estimate disease control rate
  • estimate progression free survival rate at Week 12
  • estimate PFS
  • estimate overall survival
  • estimate survival rate at one year
  • estimate duration of BOR
  • evaluate proportion of patients whose duration of response is >=24 weeks
  • estimate time to BOR
  • evaluate safety profile of ipilimumab during the induction and maintenance phases
  • evaluate health-related quality of life
  • obtain PK sample for population PK analysis

Estimated Enrollment: 150
Study Start Date: March 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ipilimumab (MDX-010, BMS-734016) Drug: ipilimumab (MDX-010, BMS-734016)
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:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with previously treated Stage III (unresectable)or Stage IV melanoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289627

  Show 61 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00289627     History of Changes
Other Study ID Numbers: CA184-008
Study First Received: February 9, 2006
Last Updated: September 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Previously treated melanoma
Unresectable Stage III
Stage IV

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 21, 2014