Study of BMS-663513 in Patients With Advanced Cancer

September 23, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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
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.
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
up to 60 days after last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CA186-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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