Phase II, 2nd Line Melanoma - RAND Monotherapy

NCT ID: NCT00612664

Last Updated: 2015-10-12

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-10-31

Brief Summary

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The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

0.1 mg/kg every 3 weeks

Group Type ACTIVE_COMPARATOR

Anti-CD137 (4-1BB) (BMS-663513)

Intervention Type DRUG

IV solution, IV, until PD or toxicity

Arm 2

1 mg/kg every 3 weeks

Group Type ACTIVE_COMPARATOR

Anti-CD137 (4-1BB) (BMS-663513)

Intervention Type DRUG

IV solution, IV, until PD or toxicity

Arm 3

1 mg/kg every 6 weeks

Group Type ACTIVE_COMPARATOR

Anti-CD137 (4-1BB) (BMS-663513)

Intervention Type DRUG

IV solution, IV, until PD or toxicity

Arm 4

5 mg/kg every 3 weeks

Group Type ACTIVE_COMPARATOR

Anti-CD137 (4-1BB) (BMS-663513)

Intervention Type DRUG

IV solution, IV, until PD or toxicity

Interventions

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Anti-CD137 (4-1BB) (BMS-663513)

IV solution, IV, until PD or toxicity

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
* Men and women, who are at least 18 years of age

Exclusion Criteria

* Ocular or mucosal melanoma
* Complete surgical resection of all identifiable sites of disease
* Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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The Angeles Clinic & Research Institute

Los Angeles, California, United States

Site Status

Yale University School Of Medicine

New Haven, Connecticut, United States

Site Status

Oncology Specialists, S.C.

Park Ridge, Illinois, United States

Site Status

Indiana University Melvin And Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Harry & Jeanette Weinberg Cancer Inst At Franklin Square

Baltimore, Maryland, United States

Site Status

Dana-Farber Cancer Inst

Boston, Massachusetts, United States

Site Status

Mem Sloan-Ket Can Ctr

New York, New York, United States

Site Status

Blumenthal Cancer Center, Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

University Of Texas

Houston, Texas, United States

Site Status

Local Institution

Calgary, Alberta, Canada

Site Status

Local Institution

Edmonton, Alberta, Canada

Site Status

Local Institution

Montreal, Quebec, Canada

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Local Institution

Aarhus C, , Denmark

Site Status

Local Institution

Odense C, , Denmark

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Local Institution

Lille, , France

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Local Institution

Paris, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Vandœuvre-lès-Nancy, , France

Site Status

Local Institution

Villejuif, , France

Site Status

Local Institution

Homburg / Saar, , Germany

Site Status

Local Institution

Jena, , Germany

Site Status

Local Institution

Kiel, , Germany

Site Status

Local Institution

Mainz, , Germany

Site Status

Local Institution

Mannheim, , Germany

Site Status

Local Institution

Tübingen, , Germany

Site Status

Local Institution

Würzburg, , Germany

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Local Institution

Genove, , Italy

Site Status

Local Institution

Milan, , Italy

Site Status

Local Institution

Napoli, , Italy

Site Status

Local Institution

Padua, , Italy

Site Status

Local Institution

Siena, , Italy

Site Status

Countries

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United States Canada Denmark France Germany Italy

Related Links

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Other Identifiers

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CA186-006

Identifier Type: -

Identifier Source: org_study_id

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