Clinical trial · Interventional
Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Recombinant Human Interleukin-21 (rIL-21) in Subjects With Metastatic Melanoma or Metastatic Renal Cell Carcinoma
NCT00095108CI-TRIAL-00002116completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to see if an experimental drug called recombinant interleukin-21 (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Metastases | Renal Cell Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human Interleukin-21 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To determine the maximum tolerated dose (MTD) of rIL-21
- measure
- To further characterize the safety of rIL-21 at the MTD
Secondary outcomes (4)
- measure
- Characterize pharmacokinetics of rIL-21
- measure
- Evaluate immunogenicity of rIL-21
- measure
- Identify clinical or biological parameters that may correlate with clinical efficacy
- measure
- Characterize anti-tumor effect of IL-21
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years and older with stage 4 metastatic malignant melanoma or stage 4 metastatic kidney cancer * ECOG status of 0 or 1 * Patients must have adequate liver, kidney and bone marrow function Exclusion Criteria: * Known ocular melanoma * Suspected or confirmed brain metastases * Patient cannot have had a bone marrow transplant
References
Publications (0)
Data not yet available
No reference posted for this study.