Melanoma
Conditions
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
Interventions
DRUGAnti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Disease response rate | end of study |
| Disease control rate | end of study |
| 1-year survival | end of study |
| Safety profiles | throughout the study |
| Pharmacodynamics | throughout the study |
| Biomarkers | throughout the study |
| Pharmacokinetics | throughout the study |
Countries
Canada, Denmark, France, Germany, Italy, United States
Outcome results
None listed