Suspended

A Single Arm, Single-centre, Open-label, Exploratory Trial of Recombinant Interleukin-21 Administered Subcutaneously for 4 Weeks as Neo-adjuvant Treatment Prior to Sentinel Lymph Node/Complete Lymph Node Dissection Followed by 8 Weeks of Adjuvant Treatment in Subjects With Stage III Malignant Melanoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

recombinant interleukin-21

Drug
Who is being recruted

Melanoma+9

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2008
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 13, 2008

Actual date on which the first participant was enrolled.

The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The trial was terminated as a result of a strategic decision by the sponsoring company.

Official TitleA Single Arm, Single-centre, Open-label, Exploratory Trial of Recombinant Interleukin-21 Administered Subcutaneously for 4 Weeks as Neo-adjuvant Treatment Prior to Sentinel Lymph Node/Complete Lymph Node Dissection Followed by 8 Weeks of Adjuvant Treatment in Subjects With Stage III Malignant Melanoma
NCT00601861
Principal SponsorNovo Nordisk A/S
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

1 patient to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

2 inclusion criteria required to participate
Stage III melanoma
ECOG performance status 0-1
2 exclusion criteria prevent from participating
Signs of stage IV melanoma
Safety variables

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Novo Nordisk Investigational Site

Berlin, GermanyOpen Novo Nordisk Investigational Site in Google Maps
SuspendedOne Study Center