Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patients older than 18 years
Signed informed consent
Metastatic non-ocular melanoma - unresectable stage III B (T1- 4a, N2b-c), stage III C (AJCC 2009) or stage IV (AJCC 2009).
measurable disease with more than one metastatic lesion, according to RECIST v. 1.1 criteria,
One of these metastases must be resectable prior to anti-CD20 therapy.
ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
As soon as BRAF or other kinase inhibitors are standard of care, we will include only patients who cannot be considered for those therapies. E.g. patients with tumors not carrying the respective mutational profile, patients refusing this kind of therapy for any reason, patients being not eligible to those therapies due to contraindications or disease progression under such kind of therapy.
Life expectancy of 3 month or longer
Negative pregnancy test in female patients of childbearing potential and adequate contraception in female patients of childbearing age.

Exclusion Criteria:

Patients with active brain metastasis (exception: brain metastases being stable with and without corticosteroids for 2 months after treatment by surgery or radiation therapy) and immunoglobulin-deficiency will be excluded.

Subjects meeting any of the following criteria must not be enrolled in an ofatumumab study:

Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
HIV positive
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to enrollment, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
Positive serology for hepatitis C (HC) defined as a positive test for HCAb (HC antibodies), in which case reflexively perform a HC RIBA (recombinant immunoblot assay) on the same sample to confirm the result
Screening laboratory values:

hemoglobin < 8g/dL platelets <70 x 109/L leukocytes <1.5 x 109/L creatinine >2.0 times ULN (upper limit of normal) total bilirubin >1.5 times ULN liver transaminase ALT >2.5 times ULN alkaline phosphatase >2.5 times ULN

Pregnant or lactating women
Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy