Clinical trial NCT00612664: Phase II, 2nd Line Melanoma - RAND Monotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
timeFrame: every 6 weeks starting at week 12 after randomization
Secondary outcomes:
measure: Safety profiles
timeFrame: throughout the study
measure: Disease response rate
timeFrame: end of study
measure: Disease control rate
timeFrame: end of study
measure: 1-year survival
timeFrame: end of study
measure: Pharmacokinetics
timeFrame: throughout the study
measure: Pharmacodynamics
timeFrame: throughout the study
measure: Biomarkers
timeFrame: throughout the study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic & Research Institute
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin And Bren Simon Cancer Center
state: Indiana
city: Baltimore
country: United States
facility: Harry & Jeanette Weinberg Cancer Inst At Franklin Square
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Inst
state: Massachusetts
city: New York
country: United States
facility: Mem Sloan-Ket Can Ctr
state: New York
city: Charlotte
country: United States
facility: Blumenthal Cancer Center, Carolinas Medical Center
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Houston
country: United States
facility: University Of Texas
state: Texas
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Aarhus C
country: Denmark
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Homburg / Saar
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Tubingen
country: Germany
facility: Local Institution
city: Wuerzburg
country: Germany
facility: Local Institution
city: Genove
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: