Phase II, 2nd Line Melanoma - RAND Monotherapy
A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma
1 other identifier
interventional
158
6 countries
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
32 active sites
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
First Submitted
Initial submission to the registry
January 30, 2008
CompletedFirst Posted
Study publicly available on registry
February 12, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedOctober 12, 2015
September 1, 2015
1.6 years
January 30, 2008
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (4)
Arm 1
ACTIVE COMPARATOR0.1 mg/kg every 3 weeks
Arm 2
ACTIVE COMPARATOR1 mg/kg every 3 weeks
Arm 3
ACTIVE COMPARATOR1 mg/kg every 6 weeks
Arm 4
ACTIVE COMPARATOR5 mg/kg every 3 weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
The Angeles Clinic & Research Institute
Los Angeles, California, 90025, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068, United States
Indiana University Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Harry & Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, 21237, United States
Dana-Farber Cancer Inst
Boston, Massachusetts, 02115, United States
Mem Sloan-Ket Can Ctr
New York, New York, 10021, United States
Blumenthal Cancer Center, Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
University Of Texas
Houston, Texas, 77030, United States
Local Institution
Calgary, Alberta, T2N 4N2, Canada
Local Institution
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution
Montreal, Quebec, H4J 1C5, Canada
Local Institution
Aarhus C, 8000, Denmark
Local Institution
Odense C, DK-5000, Denmark
Local Institution
Lille, 59037, France
Local Institution
Paris, 75010, France
Local Institution
Paris, 75651, France
Local Institution
Vandœuvre-lès-Nancy, 54511, France
Local Institution
Villejuif, 94805, France
Local Institution
Homburg / Saar, 66421, Germany
Local Institution
Jena, 07740, Germany
Local Institution
Kiel, 24105, Germany
Local Institution
Mainz, 55131, Germany
Local Institution
Mannheim, 68167, Germany
Local Institution
Tübingen, 72076, Germany
Local Institution
Würzburg, 97080, Germany
Local Institution
Genove, 16132, Italy
Local Institution
Milan, 20141, Italy
Local Institution
Napoli, 80131, Italy
Local Institution
Padua, 35128, Italy
Local Institution
Siena, 53100, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2008
First Posted
February 12, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
October 12, 2015
Record last verified: 2015-09