Study of BMS-663513 in Patients With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dose escalation

Group Type EXPERIMENTAL

BMS-663513

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No