This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Novo Nordisk Investigational Site
Box Hill, Australia
Novo Nordisk Investigational Site
East Melbourne, Australia
Novo Nordisk Investigational Site
Heidelberg, Australia
Novo Nordisk Investigational Site
Malvern, Australia
Tumor size assessed according to international criteria
Time frame: After 8 weeks
Serum levels of antibodies against recombinant human IL-21.
Markers of immunomodulation in blood.
Safety evaluation.
Time to progression.
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Novo Nordisk Investigational Site
Nedlands, Australia
Novo Nordisk Investigational Site
Parkville, Australia
Novo Nordisk Investigational Site
Westmead, Australia