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CD20-Immunotargeting in Metastatic Melanoma Patients- A Prospective, Open Label, Sequential Pilot Study

Phase 2
18 Years
Open (Enrolling)
Unresectable Stage III or Stage IV Melanoma

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Trial Information

CD20-Immunotargeting in Metastatic Melanoma Patients- A Prospective, Open Label, Sequential Pilot Study

This is a prospective, multicenter, open-label, sequential, 2-cohort, phase 2 study to
assess the overall disease control rate of Ofatumumab according to criteria of RECIST
(Response Evaluation Criteria in Solid Tumors) v. 1.1. in subjects with unresectable stage
III B (T1- 4a, N2b-c), stage III C or stage IV (American Joint Committee on Cancer 2009)

Cohort 1: 10 eligible patients will be treated with ofatumumab alone. If interim analysis
shows that at least 1 confirmed overall response occurs, an additional 19 eligible patients
will be treated, for a total of 29 patients.

Cohort 2: If no confirmed overall response by ofatumumab alone-therapy is seen in the first
10 patients, cohort 2 will be opened. Initially, 13 eligible patients will be treated with a
combination of Dacarbazine plus ofatumumab. If interim analysis gives at least 2 confirmed
overall responses, additional 26 patients will be recruited.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control according to RECIST v. 1.1 criteria

Outcome Description:

Disease control according to RECIST v. 1.1 criteria until week 24

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Stephan N Wagner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna


Austria: Agency for Health and Food Safety

Study ID:

EudraCT: 2010-023277-19



Start Date:

June 2011

Completion Date:

June 2015

Related Keywords:

  • Unresectable Stage III or Stage IV Melanoma
  • Melanoma
  • Melanoma