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Study of BMS-663513 in Patients With Advanced Cancer

This study has been terminated.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: March 29, 2006
Last updated: September 23, 2015
Last verified: September 2015
This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.

Condition Intervention Phase
Drug: BMS-663513
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Ascending Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients With Metastatic or Locally Advanced Solid Malignancies

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Assess Safety (Number and distribution and severity adverse events) of subjects [ Time Frame: Active treatment of a minimum of 3 months up until disease progression or toxicity; and long-term follow-up to assess time to progression or death will conclude 2 years after the last treatment with BMS-663513. ]

Secondary Outcome Measures:
  • Efficacy by evaluation of tumor response [ Time Frame: At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug ]
  • Assess pharmacokinetic parameters deriving from serum concentration versus time data [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 and 28, Cycle 3 Day 1 and 8, and Day 1 of every cycle the subject is on study from Cycle 4 and greater; and at study discharge. ]
  • Assess pharmacodynamic and immune response analysis [ Time Frame: up to 60 days after last dose of study drug ]

Enrollment: 115
Study Start Date: December 2005
Study Completion Date: September 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dose escalation Drug: BMS-663513
mg/kg, intravenous (IV), 0.3, 1, 3, 6, 10 or 15 mg/kg, once every 3 weeks (q 3 wks), 12 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:

  • Eastern Cooperative Oncology Group (ECOG) score of 0-1.
  • Measurable disease.
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm3
  • Platelet count >= 100K cells/mm3
  • Hemoglobin >= 9.0 g/dL
  • Total bilirubin <= 1.5 x IULN
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase <= 2.5 x institutional upper limit of normal (IULN)
  • Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma

Exclusion Criteria:

  • History of autoimmune diseases.
  • Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.
  • Active/symptomatic brain metastasis.
  • History of hepatitis B or C.
  • Concurrent malignancy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00309023

United States, California
City Of Hope National Medical Center
Duarte, California, United States, 91010
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Local Institution
Bordeaux, France, 33076
Local Institution
Paris, France, 75004
Local Institution
Paris, France, 75908
Local Institution
Saint Herblain, France, 44805
Local Institution
Villejuif Cedex, France, 94800
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT00309023     History of Changes
Other Study ID Numbers: CA186-001
Study First Received: March 29, 2006
Last Updated: September 23, 2015

Keywords provided by Bristol-Myers Squibb:
Advanced Solid Tumors processed this record on April 21, 2017