NCT00601861: Interleukin-21 around melanoma surgery: one-person study

NCT00601861 was Novo Nordisk's exploratory study of recombinant interleukin-21 in stage III melanoma with lymph-node metastases, protocol NN028-1801. It used a single-arm, open-label perioperative design: approximately four weeks of subcutaneous treatment before lymph-node surgery and eight weeks afterward. Tissue from the affected nodes was central to the biological assessment. 1 2

The registry records one actual participant and attributes termination to a sponsor strategic decision, not a safety concern. That is the sponsor's stated reason for stopping, not an independent finding that the treatment was safe or effective. The planned objectives included effects on metastatic tissue and treatment tolerability. 2

With this enrollment and no verified comparative clinical outcomes in the cited record, the study cannot establish a response rate, prevention of recurrence, or survival advantage. Its contribution is the registered attempt to examine IL-21's biological effects around melanoma surgery. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00601861. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00601861. Original registration; establishes the exact study identity and registered methods.

2. ICH GCP — ICH GCP — NCT00601861. Readable reproduction of the sponsor-submitted registration, including the design and dated status fields; not an independent outcome study.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.