Phase II, 2nd Line Melanoma - RAND Monotherapy

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Drug: Anti-CD137 (4-1BB) (BMS-663513)

• Registration Number: NCT00612664
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-01-30
• Study First Posted: 2008-02-12
• Study Start: 2008-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Disposition First Submitted: 2011-06-21
• Status Verified: 2015-09
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Anti-CD137 (4-1BB) (BMS-663513)	5 mg/kg every 3 weeks
Arm 1	Anti-CD137 (4-1BB) (BMS-663513)	0.1 mg/kg every 3 weeks
Arm 3	Anti-CD137 (4-1BB) (BMS-663513)	1 mg/kg every 6 weeks
Arm 2	Anti-CD137 (4-1BB) (BMS-663513)	1 mg/kg every 3 weeks

Primary Outcome Measures

Name	Time	Method
Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate	every 6 weeks starting at week 12 after randomization

Secondary Outcome Measures

Name	Time	Method
Biomarkers	throughout the study
Safety profiles	throughout the study
Disease response rate	end of study
Disease control rate	end of study
1-year survival	end of study
Pharmacokinetics	throughout the study
Pharmacodynamics	throughout the study

Trial Locations

Locations (11)

Blumenthal Cancer Center, Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Harry & Jeanette Weinberg Cancer Inst At Franklin Square; 🇺🇸 Baltimore, Maryland, United States

Yale University School Of Medicine; 🇺🇸 New Haven, Connecticut, United States

Local Institution; 🇮🇹 Siena, Italy

The Angeles Clinic & Research Institute; 🇺🇸 Los Angeles, California, United States

Mem Sloan-Ket Can Ctr; 🇺🇸 New York, New York, United States

Oncology Specialists, S.C.; 🇺🇸 Park Ridge, Illinois, United States

University Of Texas; 🇺🇸 Houston, Texas, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Dana-Farber Cancer Inst; 🇺🇸 Boston, Massachusetts, United States

Indiana University Melvin And Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States