Cancer, Malignant Melanoma
Conditions
Brief summary
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.
Interventions
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed surgically incurable metastatic melanoma * Patients must have measurable disease * ECOG performance status of 0 or 1 * Expected life expectancy at least 4 months
Exclusion criteria
* History of and signs/symptoms of uncontrolled brain metastases or edema. * Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.) * Radiotherapy: Radiation therapy within 4 weeks prior to entering the study. * Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size assessed according to international criteria | After 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of antibodies against recombinant human IL-21. | — |
| Markers of immunomodulation in blood. | — |
| Safety evaluation. | — |
| Time to progression. | — |
Countries
Australia
Outcome results
None listed