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Combination of Anti-CD137 & Ipilimumab in Patients With 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: NCT00803374
Recruitment Status : Withdrawn
First Posted : December 5, 2008
Last Update Posted : November 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable

Condition or disease Intervention/treatment Phase
Melanoma Drug: AntiCD137 Drug: Ipilimumab Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma
Study Start Date : November 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: 0.1 mg/kg Drug: AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Name: BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
Experimental: 0.3 mg/kg Drug: AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Name: BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
Experimental: 1.0 mg/kg Drug: AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Name: BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
Experimental: 3.0 mg/kg Drug: AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Name: BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
Experimental: 10 mg/kg Drug: AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Name: BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010


Outcome Measures

Primary Outcome Measures :
  1. Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests [ Time Frame: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received ]

Secondary Outcome Measures :
  1. Evidence of clinical improvement in tumor burden confirmed by CT or MRI [ Time Frame: Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically confirmed malignant melanoma
  • Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
  • Willing to undergo up to 3 biopsies of an accessible lesion

Exclusion Criteria:

  • Active/symptomatic brain metastases
  • Primary ocular melanoma or primary tumor of unknown origin
  • Concurrent autoimmune disease
  • Previous treatment with a CD137 agonist or CTLA-4 inhibitor
Contacts and Locations

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): NCT00803374


Locations
United States, California
Local Institution
Los Angeles, California, United States, 90025
United States, Connecticut
Local Institution
New Haven, Connecticut, United States, 06520
United States, Florida
Local Institution
Tampa, Florida, United States, 33612
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02114
Local Institution
Boston, Massachusetts, United States, 02115
Local Institution
Boston, Massachusetts, United States, 02215
United States, New York
Local Institution
New York, New York, United States, 10021
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00803374     History of Changes
Other Study ID Numbers: CA186-007
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: November 2011

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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs