Clinical trial · Interventional
Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma
A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma
NCT00389285CI-TRIAL-00002332completedPhase 1 / Phase 2ClinicalTrials.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)
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rIL-21 only | Drug | — | UNRESOLVED |
| rIL-21 + sorafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety profile, including incidence and severity of adverse events
- timeFrame
- During treatment and 28 days after last dose of rIL-21
Secondary outcomes (3)
- measure
- Objective response rate at recommended dose of rIL-21
- timeFrame
- Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached
- measure
- Progression-free survival at recommended dose of rIL-21
- timeFrame
- Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached
- measure
- Pharmacokinetic profiles of rIL-21 and sorafenib
- timeFrame
- rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of RCC of predominantly clear cell histology * Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only) * At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only) * Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only) Exclusion Criteria: * Presence of acute infection or other significant systemic illness * Central nervous system involvement by malignancy * History of other cancer within 5 years * Previously received rIL-21 or sorafenib
References
Publications (1)
- DERIVEDBhatia S, Curti B, Ernstoff MS, Gordon M, Heath EI, Miller WH Jr, Puzanov I, Quinn DI, Flaig TW, VanVeldhuizen P, Byrnes-Blake K, Freeman JA, Bittner R, Hunder N, Souza S, Thompson JA. Recombinant interleukin-21 plus sorafenib for metastatic renal cell carcinoma: a phase 1/2 study. J Immunother Cancer. 2014 Jan 27;2:2. doi: 10.1186/2051-1426-2-2. eCollection 2014. PMID 24829759