Phase II, 2nd Line Melanoma - RAND Monotherapy

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612664
• Other study ID #: CA186-006
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2008
• Last updated: September 23, 2015
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: EthikkommissionBrazil: National Committee of Ethics in ResearchBrazil: Ministry of HealthCanada: Ethics Review CommitteeDenmark: Danish Medicines AgencyGermany: Paul-Ehrlich-InstitutFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity

Locations

Country	Name	City	State
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Montreal	Quebec
Denmark	Local Institution	Aarhus C
Denmark	Local Institution	Odense C
France	Local Institution	Lille
France	Local Institution	Paris
France	Local Institution	Paris Cedex 13
France	Local Institution	Vandoeuvre Les Nancy
France	Local Institution	Villejuif
Germany	Local Institution	Homburg / Saar
Germany	Local Institution	Jena
Germany	Local Institution	Kiel
Germany	Local Institution	Mainz
Germany	Local Institution	Mannheim
Germany	Local Institution	Tubingen
Germany	Local Institution	Wuerzburg
Italy	Local Institution	Genove
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Siena
United States	Harry & Jeanette Weinberg Cancer Inst At Franklin Square	Baltimore	Maryland
United States	Dana-Farber Cancer Inst	Boston	Massachusetts
United States	Blumenthal Cancer Center, Carolinas Medical Center	Charlotte	North Carolina
United States	University Of Texas	Houston	Texas
United States	Indiana University Melvin And Bren Simon Cancer Center	Indianapolis	Indiana
United States	The Angeles Clinic & Research Institute	Los Angeles	California
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Mem Sloan-Ket Can Ctr	New York	New York
United States	Oncology Specialists, S.C.	Park Ridge	Illinois
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety profiles		throughout the study	Yes
Secondary	Disease response rate		end of study	No
Secondary	Disease control rate		end of study	No
Secondary	1-year survival		end of study	No
Secondary	Pharmacokinetics		throughout the study	No
Secondary	Pharmacodynamics		throughout the study	No
Secondary	Biomarkers		throughout the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form