Melanoma, Metastases
Conditions
Keywords
Solid tumors, Metastatic melanoma
Brief summary
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
Interventions
DRUGM200 (volociximab) in Combination with Dacarbazine (DTIC)
Sponsors
PDL BioPharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa). * Measurable disease according to Response Criteria for Solid Tumors (RECIST). * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1. * Estimated survival is greater or equal to 4 months. * Negative pregnancy test (women of childbearing potential only). * Pretreatment laboratory levels that meet specific criteria. * Signed informed consent, including permission to use protected health information.
Exclusion criteria
* Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies. * Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens. * Known sensitivity to murine proteins or chimeric antibodies or other components of the product. * Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer). * Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200. * Documented central nervous system (CNS) tumor or CNS metastasis. * History of thromboembolic events and bleeding disorders within the past year. * Medical conditions that may be exacerbated by bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a confirmed tumor response at any time during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression | — |
| Duration of tumor response | — |
| Pharmacokinetics (PK) | — |
| Immunogenicity | — |
Countries
United States
Outcome results
None listed