This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: February 9, 2006
Last updated: September 27, 2016
Last verified: September 2016
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
Intervention Model: Parallel Assignment
Masking: None (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

Enrollment: 155
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: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with previously treated Stage III (unresectable)or Stage IV melanoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00289627

  Show 54 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00289627     History of Changes
Other Study ID Numbers: CA184-008
Study First Received: February 9, 2006
Last Updated: September 27, 2016

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017