A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma
1. Must give written informed consent and any authorizations required by local law
(e.g., Protected Health Information [PHI]).
2. Aged >=18 years old at the time of informed consent.
3. Stage III and Stage IV unresectable melanoma with documented progression during or
following the most recent prior melanoma therapy.
4. Must have failed at least 1 prior therapy for metastatic disease.
5. Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely
accessible for pre treatment and post treatment biopsies.
6. Must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in
Stage 1 only).
7. Must have at least 1 measurable target lesion for CT/MRI assessment, according to
8. ECOG Performance Status <=1.
9. Acceptable laboratory results
10. Life expectancy >=12 weeks.
11. 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.
1. Subjects with any other active malignancy in addition to metastatic melanoma.
2. 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.
3. 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
4. History of hepatitis B or C.
5. Known history of HIV infection or AIDS.
6. 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.
7. Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for
melanoma within 4 weeks prior to Day 1.
8. Previous exposure to volociximab.
9. 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.)
10. Major surgery within 4 weeks prior to Day 1.
11. Requirement for immunosuppression, and/or systemic steroid therapy.
12. Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior
investigational drug (whichever is longer).
13. Known hypersensitivity to murine or chimeric antibodies.
14. Any condition that, in the opinion of the Investigator, makes the subject unsuitable
for study participation.
15. Female subjects who are pregnant or currently breastfeeding.