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

NN028-1614

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.

2004-09-01

2007-10-01

2007-10-01

Completed

Early phase I

54

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

2023-08-14