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Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma

This study has been completed.
Sponsor:
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00920907
First received: June 9, 2009
Last updated: March 28, 2013
Last verified: February 2012
History of Changes
  Purpose

The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes


Condition Intervention Phase
Advanced Melanoma
 Biological: Ipilimumab
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Parallel, Open-Label Study to Compare the Pharmacokinetics of Ipilimumab (BMS-734016) Process C to Process B in Subjects With Advanced Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetics of ipilimumab Process B and Process C derived from serum concentration versus time data [ Time Frame: Up to Week 4 (Day 22) on treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessments based on adverse event reports, vital sign measurements, physical examinations, clinical laboratory tests, and development of human anti-human antibodies [ Time Frame: Up to Week 48 on treatment ] [ Designated as safety issue: Yes ]
  • Tumor response evaluations [ Time Frame: Up to Week 48 on treatment ] [ Designated as safety issue: Yes ]
  • Absolute lymphocyte count assessed as pharmacodynamic marker pre- and post- treatment [ Time Frame: Up to Week 48 on treatment ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: August 2009
Study Completion Date: October 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab (Process B)
Reference
 Biological: Ipilimumab
Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks
Other Names:
  • BMS-734016
  • MDX010
Experimental: Ipilimumab (Process C)
Test
 Biological: Ipilimumab
Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks
Other Names:
  • BMS-734016
  • MDX010

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of malignant melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Measurable/evaluable disease per modified World Health Organization (mWHO) criteria

Exclusion Criteria:

  • Active Brain Metastasis
  • Primary ocular or mucosal melanoma
  • Prior Autoimmune disease
  • Inadequate hematologic, hepatic or renal function
  • Use of immunosuppressants
  • Prior treatment with a CD137 agonist or CTLA-4 inhibitor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920907

Locations
United States, California
The Angeles Clinic & Research Inst.
Los Angeles, California, United States, 90025
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Florida
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
St Luke'S Hospital And Health Network
Bethlehem, Pennsylvania, United States, 18015
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00920907     History of Changes
Other Study ID Numbers: CA184-087
Study First Received: June 9, 2009
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

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 May 19, 2013