The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable stage III or stage IV melanoma.
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) disease. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks
Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks. Dacarbazine administered q4w at a dose of 1000mg/m2, 4 days before next administration of Ofatumumab for 24 weeks.
Rudolfstiftung
Vienna, Austria
Medical University of Vienna
Vienna, Austria
Disease control according to RECIST v. 1.1 criteria
Disease control according to RECIST v. 1.1 criteria until week 24
Time frame: 24 weeks
Assessment of progression-free survival (PFS)
Assessment of progression-free survival (PFS) defined as the time from first day of treatment to the first documentation of disease progression or death, whichever occurs first.
Time frame: approximately 2 years
Evaluation of cell biological responses
in patients' blood and tumor samples
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
Duration of disease control
Time frame: approximately 2 years
Overall survival
Time frame: approximately 2 years
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