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Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00803374
First received: December 4, 2008
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Melanoma
 Drug: AntiCD137
Drug: Ipilimumab
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
BMS Clinical Trials Disclosure  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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00803374     History of Changes
Other Study ID Numbers: CA186-007
Study First Received: December 4, 2008
Last Updated: November 18, 2011
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