Phase II, 2nd Line Melanoma - RAND Monotherapy

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Anti-CD137 (4-1BB) (BMS-663513)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>0.1 mg/kg every 3 weeks | Drug: Anti-CD137 (4-1BB) (BMS-663513)<br>* IV solution, IV, until PD or toxicity<br>|
| Active Comparator: Arm 2<br>1 mg/kg every 3 weeks | Drug: Anti-CD137 (4-1BB) (BMS-663513)<br>* IV solution, IV, until PD or toxicity<br>|
| Active Comparator: Arm 3<br>1 mg/kg every 6 weeks | Drug: Anti-CD137 (4-1BB) (BMS-663513)<br>* IV solution, IV, until PD or toxicity<br>|
| Active Comparator: Arm 4<br>5 mg/kg every 3 weeks | Drug: Anti-CD137 (4-1BB) (BMS-663513)<br>* IV solution, IV, until PD or toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profiles |  | throughout the study | 
| Disease response rate |  | end of study | 
| Disease control rate |  | end of study | 
| 1-year survival |  | end of study | 
| Pharmacokinetics |  | throughout the study | 
| Pharmacodynamics |  | throughout the study | 
| Biomarkers |  | throughout the study |