Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00601861

Enrollment

Registered

2008-01-28

Start date

2008-02-13

Completion date

2008-06-25

Last updated

2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Malignant Melanoma

Brief summary

The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma

Detailed description

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.

Interventions

DRUGrecombinant interleukin-21

Fixed and equal dose for s.c. injection, 3 times weekly

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

Inclusion criteria

* Stage III melanoma * ECOG performance status 0-1

Exclusion criteria

* Signs of stage IV melanoma * Safety variables

Design outcomes

Primary

Measure	Time frame
Complete pathological response rate in the lymph nodes	After 4 weeks of treatment

Secondary

Measure	Time frame
Safety	For the duration of the trial
Immunomodulatory effects	For the duration of the trial
Relapse free survival	For up to 4 years after the final visit or until progression of the disease in order to assess the relapse free survival (RFS)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026