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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00612664 |
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
Condition | Intervention | Phase |
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Melanoma |
Drug: Anti-CD137 (4-1BB) (BMS-663513) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 160 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Active Comparator
0.1 mg/kg every 3 weeks
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Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
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Arm 2: Active Comparator
1 mg/kg every 3 weeks
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Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
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Arm 3: Active Comparator
1 mg/kg every 6 weeks
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Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
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Arm 4: Active Comparator
5 mg/kg every 3 weeks
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Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA186-006 |
Study First Received: | January 30, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00612664 History of Changes |
Health Authority: | United States: Food and Drug Administration; Austria: Ethikkommission; Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health; Canada: Ethics Review Committee; Denmark: Danish Medicines Agency; Germany: Paul-Ehrlich-Institut; France: Afssaps - French Health Products Safety Agency; Italy: Ethics Committee |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |