Phase II, 2nd Line Melanoma - RAND Monotherapy - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00612664

Purpose

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
Melanoma	Drug: Anti-CD137 (4-1BB) (BMS-663513)	Phase II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate [ Time Frame: every 6 weeks starting at week 12 after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profiles [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Disease response rate [ Time Frame: end of study ] [ Designated as safety issue: No ]
Disease control rate [ Time Frame: end of study ] [ Designated as safety issue: No ]
1-year survival [ Time Frame: end of study ] [ Designated as safety issue: No ]
Pharmacokinetics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Pharmacodynamics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Biomarkers [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator 0.1 mg/kg every 3 weeks	Drug: Anti-CD137 (4-1BB) (BMS-663513) IV solution, IV, until PD or toxicity
Arm 2: Active Comparator 1 mg/kg every 3 weeks	Drug: Anti-CD137 (4-1BB) (BMS-663513) IV solution, IV, until PD or toxicity
Arm 3: Active Comparator 1 mg/kg every 6 weeks	Drug: Anti-CD137 (4-1BB) (BMS-663513) IV solution, IV, until PD or toxicity
Arm 4: Active Comparator 5 mg/kg every 3 weeks	Drug: Anti-CD137 (4-1BB) (BMS-663513) IV solution, IV, until PD or toxicity

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612664

Show 30 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA186-006
Study First Received:	January 30, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00612664
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

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 13, 2009