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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289627
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : September 28, 2016
Sponsor:
Collaborator:
Medarex
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Melanoma Drug: ipilimumab (MDX-010, BMS-734016) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
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
Study Start Date : April 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.

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

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289627


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00289627    
Other Study ID Numbers: CA184-008
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Bristol-Myers Squibb:
Previously treated melanoma
Unresectable Stage III
Stage IV
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action