A Study of Volociximab in Metastatic Melanoma

Study Overview
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Brief Summary
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This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma. The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated.

Official Title
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A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma

Conditions
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Stage IV Melanoma

Intervention / Treatment
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* Drug: volociximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). Aged >=18 years old at the time of informed consent. Stage III and Stage IV unresectable melanoma with documented progression during or following the most recent prior melanoma therapy. Must have failed at least 1 prior therapy for metastatic disease. Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely accessible for pre treatment and post treatment biopsies. Must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in Stage 1 only). Must have at least 1 measurable target lesion for CT/MRI assessment, according to RECIST criteria. ECOG Performance Status <=1. Acceptable laboratory results Life expectancy >=12 weeks. Male subjects and female subjects of child bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after last infusion of study treatment. Exclusion Criteria Subjects with any other active malignancy in addition to metastatic melanoma. CNS metastases, unless stable for at least 2 months following definitive local therapy (surgery, stereotactic radiation). Subjects may not require treatment with steroids or anticonvulsants. History of any other significant medical condition, including cardiovascular, pulmonary, neurologic, or autoimmune disease; active infections (e.g., bacterial or fungal); or a psychiatric condition within 6 months of Day 1 History of hepatitis B or C. Known history of HIV infection or AIDS. History of thromboembolic or cerebrovascular events, such as stroke, transient ischemic attack, deep vein thrombosis, or bleeding disorders within 12 months prior to Day 1. Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for melanoma within 4 weeks prior to Day 1. Previous exposure to volociximab. Aspirin, high dose warfarin, or heparin use. (Note: Aspirin <=81 mg/day, low-dose warfarin 1 mg/day or low-dose heparin for IV catheter patency is allowed.) Major surgery within 4 weeks prior to Day 1. Requirement for immunosuppression, and/or systemic steroid therapy. Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior investigational drug (whichever is longer). Known hypersensitivity to murine or chimeric antibodies. Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation. Female subjects who are pregnant or currently breastfeeding.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volociximab<br>Volociximab 15 mg/kg | Drug: volociximab<br>* Volociximab, 15 mg/kg, IV infusion once a week for 8 weeks. Subjects who achieved SD or better at Day 50 ± 2 days (Week 8) were eligible to continue receiving weekly infusions of volociximab until disease progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) rate at the Week 8 visit, defined as the number of subjects who have not progressed by the Week 8 visit |  | 8 weeks intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of volociximab |  | Every infusion and follow up visit | 
| Assess safety by recording and evaluating adverse events (AEs); changes in vital signs, hematology, blood chemistry, and urinalysis parameters; and anti-volociximab antibody formation |  | Throught study and follow up period,approx. 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma, antibody, angiogenesis, volociximab