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CompletedNCT00336986Updated Aug 14, 2023

Efficacy Study of IL-21 to Treat Metastatic Melanoma

A Phase 2 interventional study of recombinant interleukin-21 in Cancer and Malignant Melanoma, sponsored by Novo Nordisk A/S. Completed at 7 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer
  • Malignant Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 54 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Interventions

  • Drugrecombinant interleukin-21
06

What researchers measure

Primary outcomes

  1. Tumor size assessed according to international criteria

    Time frame: After 8 weeks

Secondary outcomes

  1. Serum levels of antibodies against recombinant human IL-21.

  2. Markers of immunomodulation in blood.

  3. Safety evaluation.

  4. Time to progression.

07

Study locations

7 sites
  • Novo Nordisk Investigational Site
    Box Hill, 3128, Australia
  • Novo Nordisk Investigational Site
    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
08

References and documents

Publications

  • 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. PubMed 25505948 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00336986
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jun 15, 2006
Start date
Sep 2004
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Aug 14, 2023

Study contacts

Global Clinical Registry (GCR; 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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