NCT00309023

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2005

Typical duration for phase_1

Geographic Reach
3 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

March 29, 2006

Last Update Submit

September 23, 2015

Conditions

Tumors

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Assess Safety (Number and distribution and severity adverse events) of subjects

    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 Outcomes (3)

  • Efficacy by evaluation of tumor response

    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

    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

    up to 60 days after last dose of study drug

Study Arms (1)

dose escalation

EXPERIMENTAL
Drug: BMS-663513

Interventions

BMS-663513DRUG

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

dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

City Of Hope National Medical Center

Duarte, California, 91010, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Bordeaux, 33076, France

Location

Local Institution

Paris, 75004, France

Location

Local Institution

Paris, 75908, France

Location

Local Institution

Saint-Herblain, 44805, France

Location

Local Institution

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

urelumab

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 31, 2006

Study Start

December 1, 2005

Primary Completion

December 1, 2008

Study Completion

September 1, 2009

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

FR(5)US(6)CA(1)