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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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 ]

Enrollment:	158
Study Start Date:	March 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 0.1 mg/kg every 3 weeks	Drug: Anti-CD137 (4-1BB) (BMS-663513) IV solution, IV, until PD or toxicity
Active Comparator: Arm 2 1 mg/kg every 3 weeks	Drug: Anti-CD137 (4-1BB) (BMS-663513) IV solution, IV, until PD or toxicity
Active Comparator: Arm 3 1 mg/kg every 6 weeks	Drug: Anti-CD137 (4-1BB) (BMS-663513) IV solution, IV, until PD or toxicity
Active Comparator: Arm 4 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 32 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form 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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00612664 History of Changes
Other Study ID Numbers:	CA186-006
Study First Received:	January 30, 2008
Last Updated:	January 24, 2011
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Ethics Committee

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

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

ClinicalTrials.gov processed this record on May 19, 2013