Efficacy Study of IL-21 to Treat Metastatic Melanoma

August 10, 2023 updated by: Novo Nordisk A/S

An Open-label, Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 (Phase 1) Followed by an Open-label Treatment Study (Phase 2a) in Patients With Stage IV Malignant Melanoma

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: recombinant interleukin-21

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Box Hill, Australia, 3128
    - Novo Nordisk Investigational Site
  - East Melbourne, Australia, 3002
    - Novo Nordisk Investigational Site
  - Heidelberg, Australia, 3084
    - Novo Nordisk Investigational Site
  - Malvern, Australia, 3144
    - Novo Nordisk Investigational Site
  - Nedlands, Australia, 6009
    - Novo Nordisk Investigational Site
  - Parkville, Australia, 3050
    - Novo Nordisk Investigational Site
  - Westmead, Australia, 2145
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor size assessed according to international criteria Time Frame: After 8 weeks	After 8 weeks

Secondary Outcome Measures

Outcome Measure
Time to progression.
Safety evaluation.
Serum levels of antibodies against recombinant human IL-21.
Markers of immunomodulation in blood.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR; 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)