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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant interleukin-21 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor size assessed according to international criteria | After 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of antibodies against recombinant human IL-21. | ||
| Markers of immunomodulation in blood. | ||
| Safety evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR; 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Box Hill | 3128 | Australia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25505948 | Result | Coquet JM, Skak K, Davis ID, Smyth MJ, Godfrey DI. IL-21 Modulates Activation of NKT Cells in Patients with Stage IV Malignant Melanoma. Clin Transl Immunology. 2013 Oct 18;2(10):e6. doi: 10.1038/cti.2013.7. eCollection 2013 Oct. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Time to progression. |
| East Melbourne |
| 3002 |
| Australia |
| Novo Nordisk Investigational Site | Heidelberg | 3084 | Australia |
| Novo Nordisk Investigational Site | Malvern | 3144 | Australia |
| Novo Nordisk Investigational Site | Nedlands | 6009 | Australia |
| Novo Nordisk Investigational Site | Parkville | 3050 | Australia |
| Novo Nordisk Investigational Site | Westmead | 2145 | Australia |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |