Phase II, 2nd Line Melanoma - RAND Monotherapy

Completed · Phase 2

Conditions studied: Melanoma

In brief

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

Key facts

Study ID

NCT00612664

Run by

Bristol-Myers Squibb

People needed

158

Starts

2008-03-01

Expected to finish

2009-10-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Angeles Clinic & Research Institute — Los Angeles, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Indiana University Melvin And Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Harry & Jeanette Weinberg Cancer Inst At Franklin Square — Baltimore, Maryland, United States
• Dana-Farber Cancer Inst — Boston, Massachusetts, United States
• Mem Sloan-Ket Can Ctr — New York, New York, United States
• Blumenthal Cancer Center, Carolinas Medical Center — Charlotte, North Carolina, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• University Of Texas — Houston, Texas, United States
• Local Institution — Calgary, Alberta, Canada
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Montreal, Quebec, Canada
• Local Institution — Aarhus C, Denmark
• Local Institution — Odense C, Denmark
• Local Institution — Lille, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Vandœuvre-lès-Nancy, France
• Local Institution — Villejuif, France
• Local Institution — Homburg / Saar, Germany
• Local Institution — Jena, Germany
• Local Institution — Kiel, Germany
• Local Institution — Mainz, Germany
• Local Institution — Mannheim, Germany

Full record on ClinicalTrials.gov

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